A roundup of some of the biggest stories coming out of China’s pharma industry, including the news that AstraZeneca may be seeing the other side of country’s probes; the counter-sanction of US biotech Illumina; Bio X Cell’s new Beijing distribution centre, and the European approval of Shanghai Henlius Biotech’s extensive-stage small cell lung cancer therapy

 

AstraZeneca shares rise as China probe update reassures (Reuters)

AstraZeneca on Thursday said it could face a fine of up to $4.5 million in China over suspected unpaid import taxes, raising investor hopes that the impact of several probes in the country could be minor and leading its shares to rise about 5%.
The stock was hit hard last year by news of a string of investigations into the company’s executives and activities in China, which is the crown jewel of the company’s international business, accounting for 12% of total sales in 2024.

China investigates reports of bulk-buy medicine quality problems (Reuters)

Authorities in China are investigating reports of quality problems with some drugs eligible for distribution through the country’s public hospitals, the National Healthcare Security Administration said. In a notice, issued early this week, the agency said it would lead a team to Shanghai to gather feedback on the country’s drug bulk-buy procurement programmes that focus on off-patent medicines.
It said the agency “attached great importance” to reports that some drugs purchased through bulk-procurement might have quality problems.

China’s first counter-sanction on US biotech industry marks a turning point in tech war (South China Morning Post)

China’s Ministry of Commerce announced on Tuesday the inclusion of a major US biotech company on its “unreliable entity list” while stating that the firm’s “discriminatory measures against Chinese enterprises” harmed the legitimate rights and interests of Chinese companies.

Leading American genomic sequencing firm Illumina is the first biotech company on Beijing’s list. More than 60 per cent of the world’s genetic sequencing data is generated by Illumina’s machines.

Several multinational pharmaceuticals launch multiple new drugs in China amid policy boost (Global Times)

Several foreign drugmakers have announced debuts for their new drugs in the Chinese market since the beginning of 2025, as the Chinese government continues to push for opening-up in the healthcare sector.

On Monday, US-based Johnson & Johnson (J&J) announced that its Balversa (erdafitinib), a kinase inhibitor for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma, was approved by China’s National Medical Products Administration (NMPA).

Dr Reddy’s and Shanghai Henlius sign agreement for HLX15 (Pharmaceutical Technology)

Dr Reddy’s Laboratories has signed a licence agreement with Shanghai Henlius Biotech to develop and commercialise HLX15, a daratumumab biosimilar candidate to Johnson & Johnson’s (J&J) Darzalex & Darzalex Faspro. Darzalex & Darzalex Faspro are indicated to treat multiple myeloma.

The partnership leverages Dr. Reddy’s worldwide commercial network along with Henlius’ expertise in biosimilar development.

 

Bio X Cell expands global reach with new distribution centre in China (BioSpectrum Asia)

Bio X Cell, the world’s leading provider of functional antibodies for translational research, is strengthening its global distribution network with the opening of a new distribution centre in Beijing, China. This expansion marks the latest step in Bio X Cell’s growing international presence, complementing its flagship distribution centre in Germany, as well as partnerships that extend the Bio X Cell name to Singapore and Korea, along with its headquarters and manufacturing facility in New Hampshire.

The new Beijing distribution centre will enhance service to researchers and institutions across China by increasing inventory availability to expedite order fulfillment. By establishing a stronger regional presence in APAC, Bio X Cell aims to better support its customers in one of the world’s most dynamic and rapidly growing biomedical research markets.

 

Zydus and Beihai Biotech ink agreement to supply oncology drug to US market (BioSpectrum Asia)

Indian pharmaceutical firm Zydus Lifesciences has announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE has entered into an exclusive licensing, supply and commercialisation agreement with China’s Zhuhai Beihai Biotech Co., for BEIZRAY (Albumin Solubilised Docetaxel Injection), a 505(B)(2) product for the US market.

Under the terms of this agreement, Beihai Biotech will be responsible for the manufacturing and supply of the product. Zydus will be responsible for commercialisation of the product in the US.

Beihai Biotech shall receive upfront payments, sales targets-based milestone payments and a share of BEIZRAY’s net profits earned in the US as per the terms of the agreement.

 

BostonGene Collaborates with BeiGene to Advance Biomarker Discovery in Mantle Cell Lymphoma (BioSpace)

BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, today announced a collaboration with BeiGene Ltd., a global oncology company that intends to change its name to BeOne Medicines Ltd. The collaboration centers on identifying tumor-based biomarkers associated with response and resistance in Mantle Cell Lymphoma (MCL).

This initiative seeks to explain the molecular drivers of therapeutic response and resistance in MCL, a rare and aggressive subtype of B-cell lymphoma, which presents unique challenges due to its high relapse rates and frequent resistance to conventional therapies.

 

Merck halts Gardasil shipments to China, withdraws $11B sales target as demand nosedives (FiercePharma)

The continued decline of Merck & Co.’s HPV vaccine Gardasil in China has come to a head as the New Jersey drug giant is halting shipments to the world’s second-most populous country.

Thanks to ongoing market challenges, Merck is temporarily cutting off Gardasil deliveries to China from February through at least the middle of 2025. The move should help the drugmaker clear out excess doses of the vaccine cluttering its inventory, Merck said (PDF) in an earnings presentation Tuesday.

 

Shanghai Henlius Biotech’s lung cancer drug gets EU approval (China Daily)

Hong Kong-listed Shanghai Henlius Biotech Inc, a subsidiary of Fosun Pharma, announced on Wednesday that its anti-PD-1 mAb, HANSIZHUANG, or serplulimab, has been approved by the European Commission to treat extensive-stage small cell lung cancer for adult patients.

The approval makes the medicine, which is marketed as Hetronifly in Europe, as the first and only anti-PD-1 mAb approved in the EU for the treatment of extensive-stage small cell lung cancer. The approval covers all 27 EU member states as well as the European Economic Area countries, including Norway, Iceland, and Liechtenstein.