China

As biopharma derisks its business with China ‘rebalancing’ strategies, Syngene could convert majority of such pilots into full program contracts amid a challenging FY2025. The CRDMO also expects business discussions pertaining to a newly acquired US biologics site to mature into commercial opportunities.

Two potentially first-in-class molecules signify Zai Lab’s renewed drive for the in-house discovery of drugs that it requires “to be innovative, differentiated and to have the potential to make a big difference for patients,” its global R&D head tells Scrip.

CSPC’s SYS6010, the first monospecific EGFR-targeting antibody-drug conjugate in the clinic for advanced NSCLC, has shown Phase I promise, but could face close competition with another China-originated bispecific.

Akeso explains the circumstances behind the release of preliminary overall survival data from a head-to-head Phase III trial with ivonescimab in lung cancer, which some investors viewed as disappointing.

Novotech's CEO talks about rising interest for trials in regions with “regulatory agility” and “strategic insulation” from geopolitical complexity, especially among emerging and mid-sized biotech sponsors. Operational "reassessment” among some sponsors on exposure to China-based CROs/CRDMOs is another area he discussed.

Akeso’s penpulimab will be the second to hit the US market for nasopharyngeal carcinoma, but the first to win FDA approval for the indication based on clinical findings in US patients.

Over the past few months, Chinese developers of CNS and cardiometabolic therapies have attracted the interest of domestic investors, amid generally modest funding activity.

Arbele has emerged as a global leader in the Cadherin 17 area, not only in clinical progress but also for its “secret recipe” for application in T-cell engagers, its CEO tells Scrip.

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.