China

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.

Degron and TargetRx’s targeted protein degrader programs helped the firms garner new venture capital backing, while VelaVigo and Conjustar were among the others bagging new funding for antibody- and peptide-drug conjugates.

The China/US hematologic cancer-focused firm said the offering should give it runway into 2028, perhaps time enough to bring its top two pipeline assets to market in the US.

Roche's Shanghai-based Accelerator now includes close to 20 Chinese startups across multiple areas including novel modalities and AI-based research, fitting into the Swiss major's strategy of partnering in core areas to access innovation.

Acepodia’s dual-payload antibody-drug conjugates can link multiple tumor-killing agents without antibody modification. Apart from a GPC3-targeting candidate, the Taiwan-US biotech is also working on a bispecific antibody ADC with two different payloads, its CEO tells Scrip in an interview.

Throughout 2024, Chinese firms as sole sponsors initiated a total of seven global Phase III trials that including US sites. BeiGene, Genfleet and InnoCare are expected to add four similar studies this year.

The new year has already brought multiple deals for China-originated antibody-drug conjugates in the DLL3 class, which companies in the country dominate.

CARsgen's anti-Claudin 18.2 CAR-T therapy satricabtagene autoleucel has met its endpoint in a pivotal Phase II trial in later-stage gastric/gastroesophageal junction adenocarcinoma, paving the way for a China NDA filing.

CytoCares’ CEO shares plans for CC312, a potentially first-in-class trispecific antibody for autoimmune disorders it sees as differentiated from global rivals.

Some five years on from the first approval of a novel drug originated in China, 10 first-in-class drugs of Chinese origin have been commercialized. But the results have been mixed, with few actual or potential blockbusters.

In addition to C-Ray Therapeutics’ $100m-plus series A+ round, Allink Biotherapeutics and IMPACT Therapeutics closed VC/PE-backed financing deals worth $42m and $34m, respectively. Other Chinese biotechs also sealed smaller deals.

China’s fresh approval of a sublingual form of Simcere's edaravone/dexborneol brain cytoprotective agent for acute ischemic stroke is paving the way for an international Phase III study in this indication.