China

While Henlius Biotech’s PD-L1-targeting antibody-drug conjugate HLX43 is struggling to catch up with Pfizer’s PF-08046054, the global frontrunner in the space, a key differentiation of the China-originated asset could lie in PD-L1-negative patients.

China’s imposed large retaliatory tariffs on US pharmaceuticals on 10 April, but some domestic firms with in-licensed, US-origin assets were already moving to localized manufacturing.

Results from a China Phase III trial show the potential of RemeGen's fusion protein telitacicept in generalized myasthenia gravis. But study design differences make direct comparisons with argenx's FcRn inhibitor Vyvgart challenging.

Chinese biopharma companies’ alliance strategies are transitioning from immediate cash needs to more strategic management of portfolios, as MNCs continue to hunt for derisked assets.

Menarini's Asia-Pacific CEO talks to Scrip about how the Italian group is tailoring its portfolio and pricing approach to local markets making strong strides in primary care and consumer health, while also charting a distinct path in rare diseases and oncology. The China market is also a key focus including as a potential source of innovation as is partnering, where the group has a rich history.

AstraZeneca remains committed to investing in R&D and alliances in China, where Susan Galbraith, the UK major’s head of oncology R&D, sees innovation eventually reaching parity with the US and Europe.

After a more than three-year hiatus, China's Hengrui has signalled its return to multiregional Phase III trials as it looks to globalize its innovative pipeline. Meanwhile, a number of other Chinese players have announced plans to kick off Phase III trials this year and beyond.

RemeGen is planning to complete enrolment in the global Phase III RemeMG study with telitacicept in generalized myasthenia gravis by the end of 2025 or early 2026. The Chinese firm has already sidelined two other global Phase III trials with the molecule to prioritize the indication.

UK pharma will invest $2.5bn in Beijing R&D hub, build a vaccine manufacturing site with BioKangtai, and partner in chronic disease with Syneron and in oncology/immunology with Harbour BioMed.

While diverging from partner Merck & Co. in its study dosage of sacituzumab tirumotecan, Kelun has garnered the world’s first approval, in China, for a TROP2-targeting antibody-drug conjugate, for the treatment of lung cancer.

Chinese biotech TYK Medicines says its EGFR inhibitor outperformed AstraZeneca’s same-class blockbuster Tagrisso in a pivotal Phase II trial for first-line use in brain metastases resulting from EGFR mutation-positive non-small cell lung cancer.

Following approvals in China, Trinomab and Keymed have become world-first movers in tetanus prophylaxis and seasonal allergic rhinitis, respectively. But Lepu and RDO Pharm have seen their hopes for approval of an EGFR-targeting antibody-drug conjugate and an imaging agent fizzle.

Multiple Chinese companies are progressing targeted protein degraders, with oncology the dominant indication and two assets already in Phase III for breast cancer.

Shanghai-listed Amoytop will take over the non-US operations of Skyline Therapeutics for $58m in total potential payments, in a deal revealing Amoytop’s ambitions to muscle into the gene therapy field.

Finding a balance between out-licensing, refocusing on internal strengths and addressing unmet needs were identified at a recent Shanghai conference as some of the key strategies for Chinese biopharma firms looking to truly globalize.

In one sign of renewed interest in AI tools from Chinese biotechs, Harbour BioMed has linked with InSilico Medicine for antibody discovery. Meanwhile, Antengene and AIM Vaccine will use DeepSeek's AI technology to support drug and vaccine development.

SinoCellTech's PD-1 inhibitor finotonlimab has become the first immuno-oncology drug to be approved in China for first-line head and neck squamous cell carcinoma regardless of PD-L1 expression.

YolTech’s early clinical stage in vivo gene editing therapy YOLT-204 may provide off-the-shelf treatment in transfusion dependent β-thalassemia without conditioning chemotherapy and HSCT.

Innogen is hoping the approval of its once-weekly GLP-1 drug Diabegone will allow it to chip away at Ozempic’s dominance in the Chinese diabetes market.

A combination of heightened competition, destocking at vaccination clinics and a slowing economy resulted in a disappointing year for major Chinese vaccine companies.