This week’s China healthcare and pharma roundup from PharmaBoardroom content partner Selesta covers Gilead’s USD 350mn bet on in vivo CAR-T, GenFleet and Bao Pharma advancing Hong Kong IPOs, Fosun’s USD 670mn global out-licensing deal, new funding rounds for Vibrant and InxMed, and major clinical wins including Akeso’s NSCLC bispecific, AstraZeneca/Daiichi’s ADC approval, Betta and Xuanzhu’s ALK inhibitors, Wantai’s domestic HPV vaccine launch, RemeGen’s IgA nephropathy data, and Nextranslate’s RSV mRNA vaccine moving into trials.

 

Transactions & BD (In/Out Licensing)

Gilead Acquires In Vivo CAR-T Pioneer Interius BioTherapeutics

Key Words: in vivo CAR-T

  • The News: Gilead’s (NASDAQ:GILD) Kite Pharma has acquired Interius BioTherapeutics for USD 350 million, gaining its lentiviral vector platform for direct in vivo CAR-T and CAR-NK generation. This acquisition accelerates Gilead’s development of next-generation cell therapies, eliminating the need for complex ex vivo manufacturing.
  • Key Highlights: Interius’ lead candidate, INT2104, is in Phase I trials for B-cell malignancies and has demonstrated complete B-cell depletion in preclinical models with a single intravenous administration. A second program, INT2106, targets CD19+ B cells in autoimmune diseases, broadening the platform’s applications to non-oncology indications.

 

GenFleet Passes HKEX Listing Hearing with KRAS Inhibitor Portfolio

Key Words: HKEX IPO, KRAS inhibitors

  • The News: GenFleet Therapeutics has received approval for its Hong Kong Stock Exchange (HKEX) IPO after passing the listing committee hearing, with CITIC Securities as sole sponsor. The company focuses on oncology and autoimmune diseases.
  • Key Highlights:
    • Key assets include the KRAS G12C inhibitor GFH925 (approved for NSCLC) and KRAS G12D inhibitor GFH375 (in Phase II trials).
    • GenFleet retains ex-China rights to GFH925 while out-licensing Greater China rights to Innovent Biologics (HKEX:1801), with ongoing European Phase II trials evaluating its combination with cetuximab.
    • The company reported net losses of RMB 508.3 million (USD 71 million) in 2023 and RMB 677.6 million (USD 94 million) in 2024, driven by R&D investments exceeding RMB 300 million (USD 42 million) annually.

 

Bao Pharma Files for Hong Kong IPO With HKD 4.87B Valuation

Key Words: HKEX IPO, synthetic biology

  • The News: Bao Pharmaceuticals submitted its listing application to the Hong Kong Stock Exchange (HKEX) with a valuation of HKD 4.87 billion (USD 616 million).
  • Key Highlights:
    • Key assets include KJ017 (recombinant hyaluronidase for subcutaneous drug delivery) and SJ02 (long-acting FSH for fertility treatment).
    • The company has raised RMB 1.53 billion (USD 214 million) across six funding rounds.
    • IPO proceeds will fund global trials, manufacturing expansion, and pipeline advancement.

 

Fosun Licenses Immunology Drug FXS6837 to Sitala in USD 670M Deal

Key Words: out-licensing, DPP-1 inhibitor, global commercialization

  • The News: Fosun Pharma (HKEX:2196 / SHSE:600196) has out-licensed global ex-China rights for FXS6837, a small-molecule immunology drug in Phase II trials, to UK-based Sitala in a deal worth up to USD 670 million, including USD 25 million upfront and USD 480 million in sales milestones.
  • Key Highlights: FXS6837 targets immune-mediated disorders and modulates key immune pathways, including complement factor B (CFB), based on preclinical data. Fosun also gains USD 5 million in Sitala equity at no cost and will receive tiered royalties on global sales.

 

Vibrant Completes Series A Funding to Advance TCE Therapies

Key Words: T-cell engager (TCE), IND applications, Series A funding

  • The News: Vibrant Therapeutics, a Guangzhou-based biotech, raised tens of millions of USD in Series A funding led by Trinity Innovation Fund and HongShan (formerly Sequoia China). The funding will support the development of its T-cell engager (TCE) platform for solid tumors.
  • Key Highlights: Vibrant combines computational design and wet-lab validation to develop bispecific antibodies targeting tumor microenvironment (TME) antigens. The company plans to file IND applications for its first multispecific antibody programs in 2026.

 

InxMed Secures USD 34M to Develop Solid Tumor Resistance Therapies

Key Words: Series C funding, tumor resistance, FAK inhibitors, combination therapies

  • The News: InxMed completed a USD 34 million Series C round led by Fosun Health Capital to advance its therapies targeting tumor resistance mechanisms in solid cancers.
  • Key Highlights:
    • InxMed focuses on focal adhesion kinase (FAK) inhibitors and combination therapies for treatment-refractory malignancies.
    • The company has raised over USD 130 million since its founding in 2018 and is exploring global partnerships for its clinical-stage programs.

 

Clinical Development

Akeso’s Ivonescimab Shows OS Benefit in Phase III NSCLC Study

Key Words: PD-1/VEGF bispecific antibody, EGFR mutations, NSCLC, TKI resistance

  • The News: Akeso Biopharma (HKEX:9926) announced that its PD-1/VEGF bispecific antibody ivonescimab achieved significant overall survival (OS) benefits in the Phase III HARMONi-A trial for EGFR-mutant non-small cell lung cancer (NSCLC) after tyrosine kinase inhibitor (TKI) failure.
  • The Data:
    • Ivonescimab met both the primary progression-free survival (PFS) endpoint (7.06 vs. 4.8 months, HR=0.46) and the key secondary OS endpoint in Chinese patients.
    • Global partner Summit Therapeutics reported consistent efficacy in the international HARMONi trial, showing a 48% risk reduction in PFS (HR=0.52) and early positive trends in OS (HR=0.79).
    • The dual mechanism of targeting PD-1 and VEGF pathways addresses EGFR TKI resistance, a critical unmet need in approximately 50% of Asian NSCLC patients with EGFR mutations.

 

AZ, Daiichi’s TROP2 ADC Approved in China for HR+/HER2- Breast Cancer

Key Words: TROP2 ADC, HR+/HER2- breast cancer, NMPA approval

  • The News: AstraZeneca (LSE:AZN) and Daiichi Sankyo’s (TSE:4568) TROP2-targeting antibody-drug conjugate (ADC), datopotamab deruxtecan, received NMPA approval for HR-positive, HER2-negative metastatic breast cancer after endocrine therapy and chemotherapy failure.
  • The Data: Approval was based on Phase III TROPION-Breast01 trial results:
    • 37% reduction in progression risk versus chemotherapy.
    • Median progression-free survival (mPFS) of 6.9 months (vs. 4.9 months for chemotherapy).
    • Favorable safety profile with grade 3+ adverse events in 21% of patients (half the rate of chemotherapy).

 

Betta Pharma’s Ensartinib Clears Phase III Adjuvant NSCLC Trial

Key Words: ALK inhibitor, adjuvant therapy, NSCLC

  • The News: Betta Pharmaceuticals (SHSE:300558) announced that its ALK inhibitor ensartinib met the primary endpoint in a Phase III trial for postoperative adjuvant treatment of ALK-positive non-small cell lung cancer (NSCLC). The company plans to submit a New Drug Application (NDA) for this indication to expand ensartinib’s label beyond its existing approvals.
  • The Data:
    • Ensartinib demonstrated statistically significant improvement in disease-free survival (DFS) compared to placebo, addressing the unmet need of preventing recurrence in early-stage ALK-positive NSCLC patients’ post-surgery.
    • Already approved in China for first-line (2022) and second-line (2020) metastatic ALK+ NSCLC, ensartinib’s new adjuvant data strengthens its position as a comprehensive treatment option across different stages of ALK-driven lung cancer.
    • The drug, jointly developed with its US subsidiary Xcovery, became the first China-discovered ALK inhibitor approved in the US (December 2024) for first-line metastatic use.

 

Xuanzhu Bio’s ALK Inhibitor Approved for First-Line NSCLC in China

Key Words: ALK inhibitor, NSCLC, first-line treatment, brain metastases, NMPA approval

  • The News: Xuanzhu Biopharma secured NMPA approval for its next-generation ALK inhibitor XZP-3621 for treatment-naive ALK-positive NSCLC.
  • The Data:
    • XZP-3621 outperformed existing ALK inhibitors in response rates and safety.
    • Demonstrated activity against resistance mutations and achieved effective blood-brain barrier penetration for brain metastases.

 

Wantai Bio Reveals Price of its Chinese 9-Valent HPV Vaccine

Key Words: HPV vaccine

  • The News: Wantai Biopharm (SHSE:603392) launched China’s first domestically developed 9-valent HPV vaccine at RMB 499 per dose, significantly undercutting imported alternatives.
  • The Data:
    • Equivalent immunogenicity and safety to MSD’s vaccine in trials, with superior antibody levels against HPV types 52 and 58.
    • Two-dose regimen for adolescents aged 9-17 improves accessibility, while expanded age range to 45 addresses China’s bimodal HPV infection pattern.

 

RemeGen’s Telitacicept Meets the Mark in IgA Nephropathy Trial

Key Words: BLyS/APRIL dual-target, IgA nephropathy, proteinuria, autoimmune therapies

  • The News: RemeGen’s (HKEX:9995) BLyS/APRIL dual-target fusion protein telitacicept achieved the primary endpoint in a Phase III trial for IgA nephropathy, reducing proteinuria by 55% versus placebo.
  • The Data:
    • Weekly 240 mg dosing demonstrated significant reductions in 24-hour urine protein-to-creatinine ratio at 39 weeks.
    • IgA nephropathy affects 2.37 million patients in China, with 30-40% progressing to end-stage renal disease.

 

Nextranslate Bio’s RSV mRNA Vaccine NT-INF-001 Secures Clinical Trial Approvals in US and China

Key Words: RSV mRNA vaccine, clinical trial approvals

  • The News: On August 28, 2025, Nextranslate Bio (Hangzhou) Co., Ltd. announced that its RSV mRNA vaccine NT-INF-001 received clinical trial approval from the CDE (NMPA) in China. This follows its December 2024 approval by the US FDA, marking a key milestone as the vaccine achieves regulatory acceptance in both major markets.
  • The Data
    • NT-INF-001 is an RSV mRNA vaccine developed using Nextranslate Bio’s proprietary platform, featuring AI-driven codon optimization to enhance antigen expression and immunogenicity.
    • These approvals underscore NT-INF-001’s outstanding quality, safety, and efficacy, reinforcing Nextranslate Bio’s position in the global mRNA vaccine space.

 

Prepared by the Selesta Research Team.

research@selesta.ai

Selesta is a healthcare and life science advisory firm dedicated to serving Asia’s emerging entrepreneurs and businesses.

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