This week’s Asia healthcare and pharma roundup from PharmaBoardroom content partner Selesta covers the AACR 2025 ADC pipeline list from China, Puhe out-licensing global rights of a PRMT5 inhibitor to Bayer, AbbVie accusing Genmab of ADC trade secret theft on ADC technology used by ProfoundBio, and Singapore’s A*STAR investing in TW-based HoneyBear to accelerate ARC cancer drug development.
United Labs out-licenses GLP-1/GIP/GCG triple agonist to Novo Nordisk for US$2bn
United Labs (3933 HK) announced that it has out-licenced the ex. Greater China rights of UBT251, a GLP-1/GIP/GCG triple agonist for obesity and T2D, to Novo Nordisk (NOV US). United Labs is eligible to receive US$200mn upfront, up to US$1.8bn milestones, and tiered royalties. Multiple Chinese companies have struck out-licensing deals for GLP-1 therapies, including Hengrui’s (600276 CH) GLP-1 portfolio, Hansoh’s (3692 HK) HS-10535, Sciwind’s ecnoglutide, and Eccogene’s ECC5004.
Hengrui out-licenses oral Lp(a) inhibitor to Merck in a US$2bn deal
Hengrui has (600276 CH) granted Merck (MRK US) the ex. Greater China rights of HRS-5346 – an oral small molecule Lp(a) inhibitor currently in Ph II in China. Hengrui will receive US$200mn upfront and is eligible to receive up to US$1.77bn milestones, as well as royalties. Another Lp(a) inhibitor licensing transaction was struck in 2024 between CSPC (1093 HK) and AstraZeneca (AZN US) on YS2302018. CSPC will receive upfront of US$100mn, and up to US$1.92bn milestones plus tiered royalties.
[AACR 2025] ~100 innovative ADCs from Chinese biotech/pharma
AACR 2025 include ~200 presentations/abstracts related to Chinese companies. In the ADC sector, the vast majority of reports come from Chinese biotech/pharma companies, with ~100 innovative ADCs spanning diverse technology pathways and target innovations. See inside for the list of ADC pipeline candidates in AACR 2025 from China.
Chinese Pharmacopoeia 2025 Edition to take effect on Oct 1, 2025
China NMPA announced that the 2025 edition of the Chinese Pharmacopoeia will officially come into force on October 1, 2025. China NMPA also issued guidelines for compliance before and after implementation, highlighting: MAHs using drug registration standards must promptly conduct comparative studies to assess whether their standards align with the new pharmacopoeia requirements. All new drug registration applications must comply with the 2025 Chinese Pharmacopoeia standards upon submission.
South Korea to invest US$344mn in mRNA vaccine development for pandemics
South Korea government announced that it will invest 505.2bn KRW (US$344mn) during 2025-28 to create an mRNA vaccine development platform to ensure the stable supply of vaccines in preparation for a pandemic.
ADC biotech Duality Bio passes listing hearing of HKEx
Duality Bio, an ADC-dedicated biotech, passed the listing hearing of HKEx. Duality has 2 core products, DB-1303/BNT323 (HER2 ADC) and DB-1311/BNT324 (B7-H3 ADC), as well as 5 other clinical-stage ADCs and two bispecific ADCs. Currently, 5 of its clinical-stage assets have obtained IND approvals from both US FDA and China NMPA. It has established multiple global collaborations with total deal value exceeding US$6bn.
Deals and Transactions
United Labs out-licenses GLP-1/GIP/GCG triple agonist for obesity to Novo Nordisk for US$2bn
United Labs (3933 HK) announced that it has entered into an exclusive license agreement with Novo Nordisk (NOV US) for UBT251, a triple agonist of the receptors of GLP-1, GIP, and GCG in early-stage clinical development for the treatment of obesity, type 2 diabetes, and other diseases. Under the agreement, Novo Nordisk will obtain ex. Greater China rights to develop, manufacture, and commercialize UBT251. United Labs is eligible to receive an upfront payment of US$200mn, potential payments of up to US$1.8bn upon achieving development and sales milestones, and tiered royalties based on annual net sales in the licensed territory.
UBT251 is a long-acting synthetic peptide triple agonist targeting GLP-1, GIP, and GCG receptors, showing potent preclinical activity. Classified as a Class 1 innovative drug in China, UBT251 is being developed for adult type 2 diabetes, overweight/obesity, MAFLD, and CKD in China; and adult type 2 diabetes, overweight/obesity, and CKD in the US. A Ph II trial for obesity/overweight has been initiated in China. In a Ph Ib trial, weekly UBT251 at the highest subcutaneous dose of 6mg led to an average 15.1% weight loss from baseline after 12 weeks.
Multiple Chinese pharma/biotech companies are developing GLP-1 based therapies for obesity, several of which have struck out-licensing deals. In May 2024, Hengrui (600276 CH) out-licensed the ex. Greater China rights of its proprietary GLP-1 portfolio (HRS-7535, HRS9531, HRS-4729) to Hercules for US$6bn+ in total potential payments. In Dec 2024, Hansoh (3692 HK) out-licensed to Merck (MRK US) the global exclusive rights of HS-10535 (a preclinical oral small-molecule GLP-1 receptor agonist) for US$2bn+. In May 2024, Sciwind out-licensed the South Korean rights for ecnoglutide to HK Inno.N for an upfront payment of US$70mn, along with up to US$2.4bn potential milestones, plus royalties. In Nov 2023, Eccogene out-licensed the small-molecule GLP-1 agonist ECC5004 (AZD5004) to AstraZeneca (AZN US) in a deal worth up to US$1.825bn.
Source: Company announcements
Hengrui out-licenses oral Lp(a) inhibitor HRS-5346 for cardiovascular diseases to Merck in a US$2bn deal
Merck (MRK US) and Hengrui (600276 CH) announced an exclusive license agreement for HRS-5346, an investigational oral small molecule Lipoprotein(a), or Lp(a), inhibitor currently being evaluated in a Ph II trial in China. Under the agreement, Hengrui has granted Merck exclusive rights to develop, manufacture and commercialize HRS-5346 worldwide, excluding Greater China. Hengrui will receive an upfront payment of US$200mn and is eligible to receive milestone payments on certain development, regulatory and commercial milestones up to US$1.77bn, as well as royalties on net sales of HRS-5346, if approved. The transaction is expected to close in 2Q25.
Produced in the liver, Lp(a) is a type of lipoprotein that carries cholesterol, fats and proteins in the blood. Lp(a) can accumulate in blood vessel walls, forming atherosclerotic plaques similar to LDL cholesterol. These plaques can limit blood flow to vital organs and result in conditions such as heart attack, stroke and other cardiovascular diseases. Elevated Lp(a) is a genetically determined condition and an independent risk factor for cardiovascular disease. ~1.4bn people worldwide have elevated levels of Lp(a).
Another Lp(a) inhibitor licensing transaction was struck in 2024 between CSPC (1093 HK) and AstraZeneca (AZN US) on YS2302018, an early stage, novel small molecule Lp(a) inhibitor, with the aim of developing this as a novel lipid-lowering therapy with potential in a range of cardiovascular disease indications alone or in combination, including with the oral small molecule PCSK9 inhibitor, AZD0780. CSPC will receive an upfront payment of US$100mn from AstraZeneca. CSPC is also eligible to receive up to US$1.92bn for further development and commercialization milestones plus tiered royalties.
Source: Company announcement
Puhe out-licenses global rights of a PRMT5 inhibitor to Bayer
Puhe BioPharma and Bayer (BAYN DE) announced that they have entered into a global license agreement for Puhe’s oral, small molecule PRMT5 inhibitor that selectively targets MTAP-deleted tumors. Under the agreement, Bayer obtains an exclusive worldwide license to develop, manufacture and commercialize the MTA-cooperative PRMT5 inhibitor. Bayer has enrolled the first participant in a Ph I first-in-human dose escalation study under the development named BAY 3713372 for the treatment of MTAP-deleted solid tumors.
PRMT5 and a specific gene called MTAP play important roles in cell metabolism and are critical for cell survival. MTAP deletions, which occur in ~10-30% of all cancers, lead to elevated levels of MTA in tumor cells and BAY 3713372 is designed to bind the PRMT5-MTA complex thus specifically exploiting tumor vulnerability.
BAY 3713372 is an oral, potent selective MTA-cooperative PRMT5 inhibitor being evaluated as a potential new targeted treatment option for patients with MTAP-deleted solid tumors. BAY 3713372 has unique characteristics including brain penetrance, which allows targeting of CNS metastases and primary brain tumors.
Globally, 20+ PRMT5 inhibitors have entered clinical development. Among them, the most advanced candidates are in Ph II trials, with three products leading the way from BMS (BMY US), Amgen (AMG US), and Epizyme (EPZM US). In China, multiple domestic companies have also advanced their PRMT5 inhibitors into clinical stages, including CytosinLab, Genhouse, Beigene (BGNE US/6160 HK), CSPC (1093 HK), and Simcere (2096 HK).
Source: Company announcement, ClinicalTrial.gov
Merck expands partnership with Abbisko for global rights of bone-tumor treatment pimicotinib with an option fee of US$85mn
Merck (MRK US) announced a partnership with Abbisko (2256 HK) to market the bone-tumor treatment pimicotinib globally with an option fee of US$85mn, expanding its commercialization rights for the drug beyond Asia. The two companies will explore additional indications for pimicotinib, such as chronic graft-versus-host disease, after a recent late-stage study showed that the treatment significantly improved the response rate compared with placebo among patients with tenosynovial giant cell tumor, a benign tumor that grows around the joints.
Merck entered into an agreement with Abbisko in 2023 for the commercialization rights in Greater China. Pimicotinib has been granted breakthrough therapy designation by China NMPA and US FDA.
Source: Company announcement
Abbisko and Allist partner on PD-L1 + KRAS-G12C combo for NSCLC
Abbisko (2256 HK) and Allist (688578 CH) announced that they have entered into a cooperation agreement to explore the combination of Abbisko’s investigational oral PD-L1 inhibitor ABSK043, with Allist’s KRAS-G12C inhibitor gleichasib, for the treatment of NSCLC patients with KRAS-G12C mutation.
The two companies previously disclosed a separate collaboration to explore the combination of ABSK043 and furmonertinib (IVESA), developed by Allist, for the treatment of advanced NSCLC. First patient was dosed in Dec 2024. Results from an updated Ph I study showed that ABSK043 demonstrated a favorable safety profile and impressive anti-tumor activity as a single agent, with response rates higher in the subset of patients with high PD-L1 expression, and EGFR or KRAS mutations.
ABSK043 is a novel, orally bioavailable, highly selective small molecule PD-L1 inhibitor owned by Abbisko. In preclinical models, ABSK043 has demonstrated anti-tumor efficacy comparable to approved PD-L1 antibodies. There are currently no approved orally bioavailable PD-1/PD-L1 small molecule drugs. ABSK043 is currently being explored in an ongoing Ph I clinical trial for advanced solid tumors in Australia and China.
Gledrasib (AST-24081) is a KRAS G12C inhibitor. A number of clinical trials are currently ongoing in China, the US, and EU for patients with advanced solid tumors harboring KRAS G12C mutation, including combination therapy trials with SHP2 inhibitor AST-24082 in NSCLC and monotherapy trials in pancreatic cancer. Additionally, the pancreatic cancer indication has received orphan drug designation in the US and breakthrough therapy designation in China.
Source: Company announcement
Singapore’s A*STAR invests in TW-based HoneyBear, accelerating ARC cancer drug development
HoneyBear Biosciences announced a significant collaboration with Singapore’s A*STAR (Agency for Science, Technology and Research). HoneyBear has successfully secured two key licenses from A*STAR to support the development of ARC (Antibody Radionuclide Conjugates) for cancer treatment. This is A*STAR’s first investment in a Taiwanese biotech.
The agreement includes exclusive antibody license from A*STAR SIgN (Singapore Immunology Network) for ARC development, and multi-cistronic expression vector technology from A*STAR BTI (Bioprocessing Technology Institute) to enhance antibody production efficiency.
Source: Company announcement
Akeso and Transthera partner on combo of tinengotinib w/ PD-1/CTLA-4 or PD-1/VEGF BsAb
Akeso (9926 HK) and Transthera have entered into a strategic collaboration to jointly advance an open-label, multicenter Ph II clinical study to evaluate the combination of Akeso’s PD-1/CTLA-4 BsAb cadonilimab or PD-1/VEGF BsAb ivonescimab with Transthera’s innovative multi-target small-molecule kinase inhibitor tinengotinib (TT-00420) for the treatment of advanced HCC. The clinical protocol for this collaboration has recently received approval from China NMPA.
Tinengotinib is an innovative, global Ph III stage spectrum-selective kinase inhibitor that exerts antitumor effects by targeting tumor cells and improving the tumor microenvironment. Ongoing clinical trials in the US and China have revealed the potential of Tinengotinib to be efficacious in various solid tumors. It was granted the Orphan Drug Designation and Fast Track Designation by US FDA for the treatment of CCA. In July 2023, tinengotinib was granted the Breakthrough Therapy Designation by China NMPA.
Cadonilimab is the world’s first approved bispecific immunotherapy for cancer. Previous studies have shown its significant efficacy and favorable safety profile in treating HCC. Data demonstrated that cadonilimab combined with FOLFOX-HAIC as neoadjuvant therapy for resectable multinodular HCC achieved a 100% DCR with manageable safety. Furthermore, cadonilimab combined with lenvatinib as a 1L treatment for advanced HCC showed superior antitumor activity compared to approved therapies, effectively controlling tumor progression and offering long-term survival benefits over current treatment options.
Ivonescimab is a novel global first-in-class PD-1/VEGF bispecific immunotherapy. Ivonescimab was granted marketing approval by China NMPA for the treatment of EGFR mutated locally advanced or metastatic nsNSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab’s first indication has been approved in China, and Akeso is conducting 6 registrational trials versus anti-PD-1/L1 therapeutics. Akeso is also conducting multiple clinical trials of ivonescimab covering 17 indications including GC, HCC and CRC.
Source: Company announcement
Eisai to divest China rights of PPI Pariet to CBC-backed Peak Pharma for US$100mn
Eisai (4523 JP) announced that it has entered into an agreement to divest the rights for PPI (proton pump inhibitor) Pariet (rabeprazole sodium) in China to Beijing Peak Biology Pharma, a CBC Group-controlled company. Peak Pharma has commenced marketing activities, while Eisai will manage the transfer of manufacturing and marketing authorizations during a transition period. Under the agreement, Eisai will receive RMB 725mn (US$100mn) as contractual upfront payments, as well as the rights to receive a sales milestone payment.
Pariet is a PPI discovered and developed by Eisai, approved in 100+ countries and regions worldwide. Pariet was approved in China in 2000 and is indicated for gastrointestinal disorders including gastric ulcer, duodenal ulcer, and reflux esophagitis.
Source: Company announcement
Gavi terminates COVID vaccine deal with Clover, demanding US$224mn refund
Clover (2197 HK) received from Gavi (a global vaccine alliance) a one month’s prior written notice which asserts a unilateral termination of the advance purchase agreement and a letter of claim which claims for a repayment by Clover of the advanced payment of US$224mn. Clover rejected such claim for a repayment, believing it is without merit based on the terms of the advance purchase agreement.
In 2021, Gavi signed an advance purchase agreement with Clover for its SCB-2019 protein-based adjuvanted vaccine candidate against COVID-19. The agreement will make up to 414mn doses available to participants of the COVAX Facility.
Source: Company announcement
Bio-Thera out-licenses biosimilars of ustekinumab and golimumab to Dr. Reddy’s for Southeast Asia market
Bio-Thera (688177 CH) and Dr. Reddy’s (RDY US) announced that they have reached commercialization and license agreements for BAT2206 (ustekinumab biosimilar), and BAT2506 (golimumab biosimilar). Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2206 and BAT2506. Dr. Reddy’s will be responsible for seeking regulatory approvals as well as commercialization in the licensed territories in Southeast Asia, including Cambodia, Indonesia, Malaysia, Philippines, Thailand, Vietnam. In addition, Dr. Reddy’s will also receive the exclusive commercial rights of BAT2206 in Colombia.
BAT2206 is a proposed biosimilar of Stelara (ustekinumab, IL-12/IL-23). Stelara is currently approved for the treatment of 1) moderate to severe plaque psoriasis in adults and children above the age of 6 years whose condition has not improved with, or who cannot use, other systemic psoriasis treatments, 2) active psoriatic arthritis, alone or combined with methotrexate, in adults, when the condition has not improved enough with other treatments called DMARDs, 3) moderately to severely active Crohn’s disease in adults whose condition has not improved enough with other treatments for Crohn’s disease or who cannot receive such treatments, 4) moderately to severely active ulcerative colitis in adults whose condition has not improved enough with other treatments for ulcerative colitis or who cannot receive such treatments.
BAT2506 is a Simponi biosimilar (golimumab, TNF-α). Simponi is approved in the US for moderate to severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis and moderate to severely active UC.
Source: Company announcement
Roche and Merck collaborate to advance precision treatment for lung cancer in China
Roche (ROG SWX) and Merck (MRK US) jointly announced that they have officially signed an agreement to collaborate on the commercialization of Tepotinib in the mainland China market. Tepotinib is the world’s first approved MET inhibitor, which was approved for marketing in China in 2023, targeting specific sites such as METex 14 skipping mutations for the precision treatment of patients with NSCLC.
Source: Company announcement
Kaken and Alumis collaborate on TYK2 inhibitor ESK-001 dermatology in Japan
Kaken Pharma (4521 JP) and Alumis (ALMS US) announced that they have entered into a collaboration and licensing agreement to develop, manufacture and commercialize ESK-001, a highly selective, next-generation oral TYK2 inhibitor for dermatology indications in Japan, with the option to expand the license to include rheumatological and gastrointestinal diseases.
Under the agreement, Alumis will receive US$40mn in upfront and near-term co-development payments in 2025-26, up to US$140mn additional payments based on the achievement of milestones, and field option payments. Alumis is also eligible to receive tiered royalties ranging from the low double-digits into the twenties on aggregate net sales of ESK-001 in Japan. Kaken will be responsible for the clinical development, regulatory approvals and commercialization of ESK-001 in Japan, and Alumis will retain rights of ESK-001 in all other geographies. Kaken will also contribute to a portion of the global development costs of ESK-001.
Alumis’ lead clinical candidate, ESK-001, is a highly selective, next-generation oral TYK2 inhibitor that is designed to correct immune dysregulation across a spectrum of diseases driven by proinflammatory mediators, including IL-23, IL-17, and IFN. ESK-001’s selective targeting is designed to deliver maximal inhibition while minimizing off-target binding and effects. ESK-001 is currently being evaluated in the Ph III ONWARD clinical program, which consists of two parallel global Ph III, multi-center, randomized, double-blind placebo-controlled 24-week clinical trials, ONWARD1 and ONWARD2, including trial sites in Japan, designed to evaluate the efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis. Patients completing Week 24 will have the opportunity to participate in a long-term extension trial ONWARD3, which will evaluate durability and maintenance of response and long-term safety. In parallel with the Ph III clinical program, Alumis is developing a once-daily modified release oral formulation of ESK-001 designed to replace the current immediate release oral formulation that is dosed twice daily.
Source: Company announcement
Industry and Regulatory
Chinese Pharmacopoeia 2025 Edition to take effect on Oct 1, 2025
China NMPA announced that the 2025 edition of the Chinese Pharmacopoeia will officially come into force on October 1, 2025. China NMPA also issued guidelines for compliance before and after implementation, highlighting the following key points:
- MAHs (Marketing Authorization Holders) using drug registration standards must promptly conduct comparative studies to assess whether their standards align with the new pharmacopoeia requirements;
- For drugs requiring updates to registration standards, MAHs must submit supplemental applications, filings, or reports under post-market change regulations before the implementation date;
- All new drug registration applications must comply with the 2025 Chinese Pharmacopoeia standards upon submission;
- For applications already submitted but pending review by Oct 1, 2025, regulatory authorities will evaluate them against the 2025 Chinese Pharmacopoeia. Applicants must provide any additional technical materials in a single submission;
- Drugs approved between the publication date (Mar 26, 2025) and the effective date (Oct 1, 2025) under the old standards must meet the 2025 requirements within 6 months of approval.
Source: China NMPA
South Korea to invest US$344mn in mRNA vaccine development for pandemics
The Ministry of Science and ICT of South Korea announced that it confirmed the review results of the appropriateness of the business plan for the “Pandemic Preparedness mRNA Vaccine Development Support Project” during the second National Research and Development Project Evaluation Committee. The project will invest 505.2bn KRW (US$344mn) in 2025-28. This project aims to develop an mRNA vaccine platform to ensure the stable supply of vaccines in preparation for a pandemic. The government will support the mRNA vaccine from the preclinical phase to product approval.
The Korea Disease Control and Prevention Agency aims to secure a rapid development platform for mRNA vaccines through this project, enabling the rapid development of vaccines within 200 days in the event of a future pandemic. The plan is to quickly develop vaccines to establish health security and expand into various infectious diseases, cancer vaccines, and treatments for rare diseases.
Source: The Ministry of Science and ICT of South Korea
AbbVie accuses Genmab of ADC trade secret theft on ADC technology used by ProfoundBio
Abbvie (ABBV US) has filed a lawsuit against Genmab (GMAB US), accusing Genmab of being intentionally and wilfully blind to the theft of trade secrets. The case centers on ADC technology used by ProfoundBio. Genmab acquired ProfoundBio for US$1.8bn in 2024.
Abbvie alleges that ProfoundBio initially failed to produce a viable ADC pipeline, and instead, took a shortcut by tapping a former Abbvie employee, Julia Gavrilyuk, for knowledge. Gavrilyuk and Tae Han had worked together at Stemcentrx and, after that biotech was acquired by Abbvie. In 2018, Han cofounded ProfoundBio. The lawsuit claims Han was aware Gavrilyuk’s work at Abbvie involved precisely the type of ADC linkers ProfoundBio needed. Genmab has vowed to vigorously defend itself against the claims.
Source: Company announcement
Registration and Approval
Junshi’s PD-1 approved for 1L NPC in Singapore
Junshi (1877 HK/688180 CH) announced that the NDA for PD-1 toripalimab (Singapore brand name: LOQTORZI) in combination with cisplatin and gemcitabine for 1L treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic NPC has been approved by the Singapore HSA (Health Sciences Authority). Toripalimab has become the first and only approved immuno-oncology treatment for NPC in Singapore.
The approval is primarily based on the results from JUPITER-02, the first international multi-center, double-blind, randomized Ph III clinical study in NPC immunotherapy with the largest sample size. JUPITER-02 is also the world’s first Ph III clinical study with pre-set statistical verification (Type I error control) demonstrating a significant OS benefit for 1L immunotherapy combined with chemotherapy compared to chemotherapy alone in NPC. The results of the study showed that, compared to chemotherapy alone, toripalimab in combination with chemotherapy reduced the risk of disease progression by 48% and the risk of death by 37%. The mPFS in the toripalimab plus chemotherapy group was prolonged by 13.2mo compared to chemotherapy alone, from 8.2mo to 21.4mo. In addition, patients treated with this combined therapy achieved a higher ORR and longer DoR, with a CR rate of 26.7%, and no new safety signal was identified. Long-term survival follow-up data was presented at ASCO 2024, with a 5-year survival rate of 52%.
Source: Company announcement
Qingfeng’s suraxavir approved in China as the first domestic influenza drug
China NMPA released the market approval of suraxavir tablets, a Class I innovative drug co-developed by Qingfeng Pharma and Ginkgo Pharma, for the treatment of influenza A and B in individuals aged 12 and above. However, it is not indicated for patients at high risk of flu-related complications.
Suraxavir is China’s first domestic influenza antiviral drug targeting PA (polymerase acidic) protein of the influenza virus, sharing the same MoA as Xofluza (baloxavir marboxil). A key advantage is that patients only need to take a single dose for the entire course of treatment. The first batch of the drug will be commercially available in China market by May 2025.
In Jan 2025, the Ph III trial data for suraxavir were published in Nature Medicine. The study enrolled 591 patients, including ~80% adults and ~20% children/adolescents. Results showed that compared to the placebo group, suraxavir significantly shortened the median time to symptom relief by 21hr and reduced viral shedding time by 25hr, with no reports of SAE.
Source: China NMPA
Eli Lilly’s Nectin-4 ADC LY4052031 approved for clinical trials in China
Eli Lilly (LLY US) has received approval from China NMPA for its IND application of LY4052031 to enter clinical trials. The drug, an ADC targeting Nectin-4, is designed to treat late-stage or metastatic urothelial cancer and other solid tumors. This marks the first time an ADC from Eli Lilly has been approved for clinical trials in China.
Preclinical studies have shown that LY4052031 exhibits strong cytotoxicity against tumor cells with both high and low expression of Nectin-4. The drug has also demonstrated potent in vivo efficacy in various tumor models expressing Nectin-4 and resistant to MMNE. Overall, LY4052031 shows specificity, selectivity, potency, and efficacy as a next-generation therapy for Nectin-4-positive tumors.
Globally, there are 10+ Nectin-4 ADCs entering clinical development, with only enfortumab vedotin from Pfizer (PFE US) currently approved for commercialization. SHR-A2102 from Hengrui (600276 CH) and 9MW2821 from Mabwell (688062 CH) have advanced to Ph III clinical trials.
Source: China NMPA, ClinicalTrial.gov
Hengrui’s Nectin-4 ADC SHR-A2102 approved for Ph II trials in China in advanced solid tumors
Hengrui (600276 CH) received clinical trial approval from China NMPA for Nectin-4 ADC SHR-A2102. The approval grants permission to initiate a multicenter, open-label Ph II clinical study evaluating the safety, tolerability, and efficacy of SHR-A2102 in combination with other anti-tumor therapies for advanced solid tumors.
SHR-A2102 is a proprietary Nectin-4 ADC developed by Hengrui, carrying a TOPi (topoisomerase I inhibitor) payload. Several trials are ongoing in China for UC, EC, NSCLC, and advanced gynecologic malignancies. In Dec 2024, SHR-A2102 monotherapy was included in China’s BTD (Breakthrough Therapy Designation) list for platinum-refractory, PD-(L)1-resistant UC. In Apr 2024, US FDA granted FTD (Fast Track Designation) for advanced UC.
Source: China NMPA
AstraZeneca’s PTHR1 agonist eneboparatide for chronic hypoparathyroidism approved for China clinical trials
AstraZeneca’s (AZN US) innovative peptide drug, eneboparatide, has been approved for clinical trials in China. The drug, developed by Alexion (ALXN US), a subsidiary of AstraZeneca, is indicated to treat chronic hypoparathyroidism, a rare endocrine disorder.
The approval comes after AstraZeneca acquired Amolyt, a biotech specializing in rare endocrine diseases, for US$10.5bn in 2024. This acquisition granted AstraZeneca the rights of eneboparatide, a peptide drug with a novel mechanism of action. Eneboparatide is a PTHR1 agonist that restores the function of PTH (parathyroid hormone), managing symptoms in HypoPT patients while preserving renal function and bone health. The drug has already received Fast Track and Orphan Drug designations from US FDA and Orphan Drug designation from EMA.
Source: China NMPA, company announcement
CStone files MAA of PD-L1 for Stage III NSCLC in EU
CStone (2616 HK) announced the submission of MAA to EMA for sugemalimab, seeking approval for the treatment of patients with unresectable stage III NSCLC who have not progressed following concurrent or sequential platinum-based CRT (chemoradiotherapy). This marks CStone’s 2nd regulatory submission for sugemalimab to EMA, following its initial approval in EU for metastatic sqNSCLC and nsNSCLC in 2024.
The submission is supported by data from the GEMSTONE-301 Ph III trial, a multicenter, randomized, double-blind study evaluating sugemalimab as consolidation therapy in patients with unresectable stage III NSCLC post-CRT. Results demonstrated 36% reduction in risk of disease progression or death, significantly improved PFS; 56% reduction in risk of death, with a strong positive trend toward OS benefit; consistent clinical benefits across subgroups, regardless of prior CRT modality (concurrent or sequential); and favorable safety profile, with no new safety signals identified.
To date, China NMPA has approved sugemalimab for five indications, including 1) in combination with chemotherapy for 1L treatment metastatic sqNSCLC and nsNSCLC; 2) or unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based CRT; 3) R/R extranodal NK/T-cell lymphoma; 4) in combination with fluorouracil and platinum-based chemotherapy as 1L treatment of unresectable locally advanced, recurrent or metastatic ESCC; and 5) in combination with fluoropyrimidine- and platinum-containing chemotherapy as 1L treatment for unresectable locally advanced or metastatic G/GEJ adenocarcinoma with a PD-L1 expression.
Source: Company announcement
HEC’s innovative encofosbuvir for HCV approved in China
HEC Pharma (1558 HK) announced that its encofosbuvir tablets (0.3g) has been approved by China NMPA for marketing. The drug is a Class I innovative drug in China. In combination with netanasvir phosphate capsules, the drug is indicated for the treatment of HCV (Hepatitis C virus) infection in adults with genotypes 1, 2, 3, and 6 in primary or interferon-treated cases, which may or may not be comorbid with compensated cirrhosis.
Previously, HEC’s emitasvir phosphate capsules, a Class I innovative drug, was approved for launching in 2020 in China and has been shortlisted in the NDRL.
Source: Company announcement
Kelun-Biotech’s novel RDC for bone metastases approved for clinical trials in China
Kelun-Biotech (6990 HK) announced that it has received clinical trial approval for the IND application of SKB107 from China NMPA. SKB107 is a novel RDC jointly developed with the Department of Nuclear Medicine of the Affiliated Hospital of SMU. It utilizes a small molecule as the targeting ligand, combined with a suitable conjugation technology, chelator, and therapeutic radionuclide, and is intended to be indicated for the treatment of bone metastases in solid tumors.
Source: Company announcement
Henlius files MAA for pertuzumab biosimilar in EU for BC
Henlius (2696 HK) announced that the MAA for HLX11 (pertuzumab biosimilar) has been validated by EMA for the following indications: 1) in combination with trastuzumab and chemotherapy in the neoadjuvant treatment of adult patients with HER2+, locally advanced, inflammatory, or early-stage BC at high risk of recurrence; and the adjuvant treatment of adult patients with HER2+ early BC at high risk of recurrence; 2) in combination with trastuzumab and docetaxel in adult patients with HER2+ metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
HLX11, which was independently developed by Henlius, is a pertuzumab biosimilar. It is indicated for the neoadjuvant/adjuvant treatment of HER2+ early BC, the treatment of HER2+ metastatic BC, and/or for other indications consistent with those on the label of the original biologic. In Sep 2024, an international multi-center Ph III study of HLX11 met the primary study endpoint. In Dec 2024, the NDA for HLX11 was accepted by China NMPA. In Jan 2025, the BLA for HLX11 was accepted by US FDA. In Jun 2022, Henlius entered into a license and supply agreement with Organon (OGN US), pursuant to which, Henlius granted an exclusive license to Organon to commercialize HLX11 globally ex. Greater China.
Source: Company announcement
IASO Bio’s BCMA CAR-T approved in Macau for R/R MM
IASO Bio announced that the NDA for FUCASO (equecabtagene autoleucel) has been approved in Macau for adult patients with R/R MM who have received 3+ lines of prior therapies, including at least one proteasome inhibitor and an immunomodulatory agent.
This is the first NDA approval for FUCASO outside mainland China. FUCASO was approved by China NMPA in 2023 for adult patients with R/R MM who have received 3+ lines of prior therapies, including at least one proteasome inhibitor and an immunomodulatory agent. The Macau NDA approval is based on data from the pivotal FUMANBA-1 trial, a China-based, multi-site, Ph I/II registrational study evaluating the efficacy and safety of equecabtagene autoleucel in patients with R/R MM. The NDAs for FUCASO was formally accepted by the pharmaceutical authorities in Singapore and Hong Kong in Jan and Feb 2025, respectively.
FUCASO is an innovative fully human anti-BCMA CAR-T cell therapy which uses lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully human scFv, CD8a hinge and transmembrane, and 4-1BB co-stimulatory and CD3ζactivation domains. Based on rigorous molecular structure screening and comprehensive in vitro and in vivo functional evaluations, FUCASO demonstrates rapid and potent efficacy, accompanied by exceptional long-term persistence in vivo, enabling patients to achieve higher and deeper responses, providing continuous protection and care for patients with MM.
Source: Company announcement
Viva’s Langhua passes its 4th US FDA cGMP inspection
Langhua Pharma, a wholly-owned subsidiary of Viva Biotech (1873 HK), has passed its 4th on-site cGMP inspection by US FDA. Following the inspection, the company received an EIR (Establishment Inspection Report), confirming compliance with US FDA requirements. The inspection conducted in 2H24 assessed 6 major systems: quality, materials, production, packaging and labelling, equipment and facilities, and laboratory control.
Langhua operates as a one-stop CDMO, offering small molecule drug solutions from APIs to FDFs. With a presence in Shanghai, Ningbo, and Taizhou, the company boasts over 13,000 square meters of laboratory space and a research team 700+ members. It has secured regulatory approvals from multiple authorities, including US FDA, China NMPA, EDQM, PMDA, ANVISA, and WHO, while also passing the PSCI audit.
Source: Company announcement
Ractigen’s RAG-01C IND approved in China as the first saRNA to enter clinical stage in the country
Ractigen announced that its proprietary saRNA (small activating RNA) RAG-1C for the treatment of PVR (proliferative vitreoretinopathy) has received IND approval from China NMPA. RAG-1C becomes China’s first saRNA drug to enter clinical trials.
RAG-01C is designed to boost expression of a cell cycle inhibitory gene in proliferating cells of the eye following surgery or injury via RNAa in order to stop development of scarred tissue and breaks in the retina. RAG-01C is intended to provide better surgical outcomes and limit the need for recurrent surgeries by preventing PVR formation. The approved Ph I trial is a multicenter, randomized, double-blind, dose-escalation first-in-human study designed to evaluate the safety, tolerability, PK, and preliminary efficacy of RAG-1C in preventing PVR progression post-vitrectomy.
Previously, Ractigen’s first saRNA candidate, RAG-01, obtained IND approval from US FDA and demonstrated positive preliminary efficacy and safety data in an ongoing Ph I trial in Australia. RAG-1C is the company’s 2nd saRNA program to advance into clinical development.
Source: China NMPA
Zoye Med’s first-in-class AI-powered percutaneous surgical robot approved in China
Zoye Medical has received Class III medical device certification from China NMPA for the world’s first AI-powered surgical robot capable of performing percutaneous procedures with submillimeter accuracy.
The AI-powered surgical navigation robot incorporates several ground-breaking technologies that set new standards in minimally invasive procedures. Its proprietary 3D structured light fusion positioning system uses advanced scanning technology to achieve modeling accuracy of submillimeter, a fourfold improvement over traditional CT-guided methods. The system’s hand-eye coordinated robotic arm features sophisticated force-feedback algorithms that allow surgeons to seamlessly switch between autonomous operation and manual control.
Source: Company announcement
SineuGene’s first-in-class TRIM72 gene therapy granted IND approval for ALS in the US
SineuGene announced that US FDA has approved its IND application for SNUG01 – a first-in-class TRIM72 (Tripartite Motif Protein 72)-targeted gene therapy candidate for ALS (amyotrophic lateral sclerosis). The approval authorizes a global Ph I/IIa clinical trial designed to evaluate SNUG01’s safety, tolerability, and preliminary efficacy in adults with ALS through a dose-escalation and expansion study.
SNUG01 utilizes a rAAV9 (recombinant adeno-associated virus serotype 9) capsid to deliver the human TRIM72 gene via intrathecal administration. Preclinical studies demonstrate TRIM72’s ability to counteract ALS pathogenesis through several synergistic mechanisms such as reducing oxidative stress by scavenging ROS (reactive oxygen species), restoring mitochondrial homeostasis, suppressing stress granule dysregulation, inhibiting neuroinflammatory cascades, and enhancing neuronal membrane repair capacity.
In an IIT at Peking University Third Hospital, SNUG01 demonstrated a favorable safety and tolerability profile, along with early efficacy signals in both functional clinical assessments and key biomarkers of neurodegeneration. These results enhance the translational validation of TRIM72, bridging target discovery, preclinical models, and human proof-of-concept.
Source: Company announcement
Funding and Capital Markets
Duality Bio passes listing hearing of HKEx
Duality Bio, a biotech dedicated to the development of ADC, passed the listing hearing of HKEx, with Morgan Stanley, Jefferies and CITIC Securities being its joint sponsors.
Duality has self-discovered 2 core products, namely DB-1303/BNT323 (HER2 ADC) and DB-1311/BNT324 (B7-H3 ADC), as well as 5 other clinical-stage ADCs, two bispecific ADCs and multiple other preclinical ADCs. Currently, 5 of its clinical-stage assets have obtained IND approvals from both US FDA and China NMPA.
- DB-1303/BNT323: An ADC candidate targeting HER2+ cancers including EC and BC. It is currently undergoing two registrational trials (one global and one in China), with another global registrational study planned. The first indication (HER2-expressing EC) is expected to seek accelerated US FDA approval as early as 2025.
- DB-1311/BNT324: An ADC candidate targeting B7H3+ cancers, including SCLC, CRPC, and ESCC.
The company’s innovative ADC assets have attracted partnerships with leading biopharma companies, establishing multiple global collaborations, including with BioNTech (BNTX US), Beigene (6160 HK/BGNE US), Adcendo (ADCT US), GSK (GSK US), and Avenzo. The total value exceeds US$6bn, with US$400mn received as of Feb 19, 2025.
Source: HKEx
Synthgene completes B+ round financing led by Leader VC
Synthgene, a Medtech specializing in POCT diagnostic products and molecular tumor diagnostics, announced the completion of its B+ round financing. The investment was led by Leader VC, with the specific amount undisclosed.
Founded in 2018, Synthgene is a technology-driven Medtech that provides comprehensive upstream raw material solutions for the life sciences sector. The management team, consisting of PhD graduates from Nanjing University, has long been dedicated to R&D in gene-based nucleic acid drugs and upstream raw materials for IVD. The company has established key platform technologies, including mAb preparation, mRNA in vitro transcription synthesis, and oligonucleotide synthesis.
Source: Company announcement
Anda Biotech closes Series A funding to advance personalized cancer vaccine pipeline
Anda Biotech, a pioneer in AI-driven neoantigen therapies, announced the completion of a Series A financing round, raising tens-of-millions RMB. The investment was co-led by Leading Capital and Puyao Xinye Investment, with participation from Linchuang Sinan, Botong Venture Capital, and DFJ. Proceeds will be used to accelerate clinical trials for its lead candidate PCNAT-01, a personalized pancreatic cancer vaccine, and advance preclinical programs.
Founded in 2018, the Shenzhen-based company pioneers in AI-powered novel antigen therapeutics. Its proprietary “AD-INN” platform integrates deep learning algorithms with multi-omics data, single-cell sequencing, organoid-on-chip models, and digital twin technology to establish a fully automated R&D loop from novel antigen discovery to vaccine validation.
Source: Company announcement
Hisky Medical completes Series D funding raising RMB100mn+
Hisky Medical announced the completion of its Series D financing round, raising RMB100mn+ (US$14mn+). The round was led by Riverhead Capital, with participation from Hunan Medical Development Fund and Guangzhou Biotech Island Life Science Innovation Fund. The proceeds will be used to accelerate the global commercialization of its medical imaging platforms and fuel R&D in next-generation non-invasive diagnostic technologies.
Founded in 2010 in Wuxi, Jiangsu Province, and originating from Tsinghua University, Hisky Medical pioneers accessible precision diagnostics. The company’s core products – iLivTouch non-invasive liver assessment system, CelTouch confocal microprobe imaging system, and EQTouch premium ultrasound platform – leverage proprietary acoustic and optical technologies to revolutionize screening and management of liver, metabolic, and respiratory diseases. With certifications from US FDA, CE, PMDA, TGA, KFDA, and RZN, Hisky’s devices are marketed across 60+ countries, serving tens of millions of patients through partnerships with leading hospitals and health screening centers worldwide.
Source: Company announcement
Drug/Medtech R&D
AACR 2025 abstracts published with ~100 innovative ADC pipeline candidates from Chinese biotech/pharma
The American Association for Cancer Research (AACR) Annual Meeting 2025 is set to be held April 25 to 30 in Chicago. Abstracts have been published on the website and include ~200 presentations/abstracts related to Chinese companies. In the ADC sector, the vast majority of reports come from Chinese biotech/pharma companies, with ~100 innovative ADCs spanning diverse technology pathways and target innovations.
Bispecific ADCs are currently one of the hottest directions in the ADC sector. Companies such as Bliss Bio, Biocytogen, BioRay, VelaVigo, DAC Biotech, Hengrui (600276 CH), CStone (2616 HK), Chuangchun High-tech (000661 CH), Alphamab (9966 HK), Kyinno, Lianjin Bio, GeneQuantum, CSPC (1093 HK), Phrontline, Simcere (2096 HK), Innovent (1801 HK), DualityBio, and Affinity Bio are actively developing innovative bispecific ADCs. Dual-toxin ADCs are also emerging as a novel frontier. Kanghong (002773 CH), DAC Biotech, Alphamab and Affinity Bio are advancing dual-toxin ADC platforms.
Source: AACR 2025
Innovent doses first patient in Ph III trial of HER2 ADC IBI354 for PROC
Innovent (1801 HK) announced that the first patient has been dosed with its HER2 ADC IBI354 in a randomized, controlled, multicenter Ph III trial (HeriCare-Ovarian01), for PROC (platinum-resistant ovarian cancer) with HER2 expression. HeriCare-Ovarian01 is the first Ph III trial in China to investigate PROC with HER2 expression (IHC 1+, 2+ or 3+). The study will evaluate the safety and efficacy of IBI354, compared with investigator’s choice of chemotherapy for PROC with HER2 expression. The primary endpoints are PFS and OS.
Previously, in a multicenter Ph I/II study in patients with advanced solid tumors, a total of 87 patients with PROC were enrolled and were treated with 6-12mg/kg doses of IBI354. 67 (77.0%) participants had previously received at least 3 anti-tumor regimens. As of July 24, 2024, ORR was 40.2% and DCR was 81.6%. Among them, ORR reached 52.5% and DCR reached 90.0% in 40 ovarian cancer participants treated with 12mg/kg Q3W. ORR reached 55.6% and DCR reached 88.9% in 27 subjects with HER2 IHC 1+ (12mg/kg Q3W dose group). The median follow-up time of 12mg/kg Q3W dose group was 6.5mo as of the cut-off date, and PFS and DoR were not mature. In the Ph I/II clinical study (N=368), IBI354 demonstrated an excellent safety profile. No DLT was occurred up to 18mg/kg dose group. The overall incidence of Grd 3+ TRAEs was 21.5%, the incidence of TRAEs leading to dose interruption was 12.2%, the incidence of TRAEs leading to dose reduction was 2.4%, the overall incidence of TRAEs leading to discontinuation was 1.6%, and no TRAE leading to death reported.
Source: Company announcement
GenFleet publishes promising Ph II data for KRAS G12C Inhibitor w/ cetuximab for 1L NSCLC
GenFleet announced the latest Ph II data of KROCUS study, fulzerasib (GFH925, KRAS G12C inhibitor) in combination with cetuximab for 1L NSCLC at the mini oral presentation of the 2025 ELCC (European Lung Cancer Conference) annual meeting.
The KROCUS study is an EU multi-center Ph Ib/II trial initiated in Mar 2023. As of Jan 14, 2025, 47 patients were enrolled and 45 received at least one post-treatment tumor assessment: ORR reached 80% and DCR reached 100%. The post-treatment evaluation revealed 3 patients achieved CR; 33 others reached PR, including one with 100% tumor shrinkage; 57.8% of patients exhibited≥50% tumor shrinkage. As data cut-off date, the median follow-up was 12.8mo, and the mPFS was 12.5mo. 34% of enrolled patients had baseline brain metastasis, and ORR was 71.4% per RECIST 1.1 among brain-metastatic patients who received at least one post-treatment tumor assessment; all non-target lesions of brain-metastatic patients disappeared or remained stable in the course, and brain target lesions of 5 patients exhibited shrinkage.
The combination therapy displayed a highly favorable safety/tolerability profile, with a lower incidence of TRAEs than that of fulzerasib monotherapy for 2L+ NSCLC treatment; Grd 3+ TRAEs occurred at a considerably lower rate than that of fulzerasib monotherapy (no Grd 4 or 5 TRAEs in KROCUS study).
Fulzerasib is the first China domestic KRAS G12C inhibitor that has its NDA submission accepted and granted with Priority Review Designation by China NMPA. Fulzerasib also received Breakthrough Therapy Designations in 2025 for advanced KRAS G12C-mutant NSCLC patients that have received at least one systemic therapy and CRC patients who have received at least two systemic therapies.
Source: Company announcement
ArkBio completes China Ph III trial for new-generation methylphenidate drug AK0901 in ADHD
ArkBio announced the successful completion of the Ph III clinical study of AK0901, a novel drug for the treatment of ADHD (attention deficit hyperactivity disorder). ArkBio in-licensed the Greater China rights of AK0901 from Commave in 2021 for US$105.5mn in upfront, regulatory milestones and sales milestones, along with tiered royalties. AK0901 (Azstarys) received US FDA approval in 2021 as the new-generation methylphenidate drug in nearly two decades, demonstrating superior safety and clinical efficacy, and a potential as best-in-class therapeutic drug for the treatment of pediatric ADHD.
AK0901, a novel methylphenidate-based drug, is the first and only drug combining two active components of immediate-release d-MPH (dexmethylphenidate) and prodrug SDX (serdexmethylphenidate). It works by inhibiting the reuptake of dopamine and norepinephrine in the synaptic cleft, enhancing neurotransmitter efficiency to alleviate ADHD symptoms.
The Ph III study of AK0901 in China was led jointly by Beijing Anding Hospital affiliated with Capital Medical University and Peking University Sixth Hospital, with the participation of eight clinical centers nationwide. The study aimed to evaluate the efficacy, safety, and tolerability of oral AK0901 in children with ADHD aged 6 to 12. The study results met both primary and key secondary endpoints and reached statistical significance in all the visiting time points compared to placebo, which provides a strong scientific basis for future treatment of Chinese ADHD patients.
Source: Company announcement
AstraZeneca initiates Ph I/II trial of BCMA/CD19 CAR-T acquired through Gracell M&A in SLE
AstraZeneca registered a Ph I/II clinical trial for AZD0120 (GC012F) in patients with relapsed SLE (systemic lupus erythematosus). The trial plans to enroll 150 relapsed SLE patients, with completion targeted for 2029. Compared to single-target CD19 CAR-T therapies, AZD0120’s BCMA/CD19 bispecific CAR-T design enables more comprehensive clearance of autoantibody-producing B cells and plasma cells.
Developed by Gracell (acquired by AstraZeneca for US$1.2bn in 2023), the FasTCAR platform addresses key industry challenges of 1) manufacturing efficiency: reduces production time from weeks to just 1 day, significantly lowering costs and improving accessibility; 2) enhanced persistence: enriches stem cell memory T cells, improving durability and allowing lower dosing; and 3) safety profile: reduced toxicity while maintaining efficacy.
AZD0120, as a core product developed on the FasTCAR platform, leverages its dual-targeting BCMA/CD19 design to: 1) broaden patient coverage – by simultaneously targeting autoantibody-producing B cells (via CD19) and long-lived plasma cells (via BCMA); 2) minimize relapse risk – through comprehensive immune cell clearance, reducing antigen escape observed in single-target therapies.
Source: ClinicalTrial.gov
Huitai announces positive topline data for anti-pulmonary fibrosis inhaled drug HTPEP-001 in Ph I trial
Huitai Biomedcine (688617 CH) announced the successful completion of the Ph I trial for its inhaled drug candidate HTPEP-001, with positive topline data achieved in all subjects and all primary and secondary endpoints met.
The randomized, double-blind, placebo-controlled Ph I trial evaluated the safety and tolerability of HTPEP-001 in healthy volunteers across escalating doses ranging from 1mg to 24mg. The PK profile of HTPEP-001 in healthy subjects, as well as local irritability tests related to inhalation administration, were consistent with preclinical model results. All dose groups demonstrated favorable safety and tolerability. All TRAEs were mild and resolved by the end of the study. No AEs related to nebulized inhalation were observed, nor were there any AEs commonly reported from other drugs with similar MoA. Notably, the 24mg dose tested in this trial was significantly higher than the theoretical effective dose, further supporting the drug’s wide therapeutic window.
Source: Company announcement
Henlius doses first patient in Japan under the Ph III trial of HER2 mAb HLX22 for 1L GEJ/GC
Henlius (2696 HK) announced the first patient in Japan has been dosed in an international multi-center Ph III clinical study of HLX22 (anti-HER2 mAb) in combination with trastuzumab and chemotherapy (XELOX) vs. trastuzumab and chemotherapy (XELOX) with or without pembrolizumab for 1L HER2+ locally advanced or metastatic GEJ/GC. This Ph III clinical study is also ongoing in mainland China.
In this double-blind, randomized, controlled multicenter Ph III study, eligible participants will be randomized at 1:1 to the experimental arm (treated with HLX22 (15mg/kg) in combination with trastuzumab and chemotherapy) or the control group (placebo plus trastuzumab and chemotherapy w/ or w/o pembrolizumab). The primary endpoints are PFS assessed by IRRC per RECIST v1.1 and OS, and the secondary endpoints include investigator-assessed PFS, IRRC or investigator-assessed ORR, PFS2, DOR, quality of life, safety, immunogenicity and pharmacokinetic characteristics.
HLX22 is an innovative anti-HER2 mAb in-licensed from AbClon in 2016, and subsequently self-developed by Henlius with potential indications including GC, BC and other solid tumours. In Mar 2025, HLX22 was granted Orphan Drug Designation for the treatment of GC by US FDA.
Source: Company announcement
Disclaimer
Selesta is a unique boutique healthcare and life science firm dedicated to serving Asia’s emerging entrepreneurs and businesses.
© 2025 Selesta
