Hongyun Biotech Co. Ltd. raised ¥100 million (US$15.5 million) in a series B round to move its new generation EGFR inhibitor, RC-01, to the IND stage in China and the U.S. for non-small-cell lung carcinoma (NSCLC). The plan is to finish the IND filing by the end of this year and start the trial in 2022.
Sinocelltech Group Ltd. won market approval from China’s NMPA for SCT-800, a B-domain deleted recombinant human coagulation factor VIII, for the prophylactic treatment of severe hemophilia A in adolescent and adult patients. This marks the first homegrown drug for treating hemophilia A in China.
China’s NMPA gave conditional approval to Henan Sincere Biotech Co. Ltd.’s dual-targeting, oral HIV drug, azvudine, to treat HIV-1-infected adult patients with high viral loads. Azvudine could challenge lamivudine, a drug extensively used for treating HIV infection.
Jiangsu Hengrui Medicine Co. Ltd. reported positive interim data from its phase III trial for SHR-3680, an androgen receptor antagonist, demonstrating that it reduced the risk of disease progression or death in metastatic hormone-sensitive prostate cancer patients with high-volume disease burden.
Innovent Biologics Inc. and Ascentage Pharma Group Corp. Ltd. inked a three-component collaboration that comes with joint commercialization of an NDA-stage Bcr-Abl inhibitor and co-development of combination therapies, as well as Innovent taking a stake in Ascentage. The collaboration involves a deal worth up to $145 million and a $50 million investment.
China’s Center for Drug Evaluation has released the guideline on developing oncology drugs with a clinical value-oriented approach, part of its ongoing efforts to encourage the development of truly innovative oncology drugs in China.
The lack of data surrounding the efficacy of Chinese COVID-19 vaccines against the Delta variant has had many questioning them, especially after a recent study showed that one of those vaccines, Sinovac Biotech Ltd.’s Coronavac, was less effective than Pfizer Inc. and Biontech SE’s Comirnaty in Chile.
Harbour Biomed Therapeutics Ltd. said its anti-FcRn monoclonal antibody, batoclimab, generated top-line phase II data in generalized myasthenia gravis, and the company expects to move into a phase III study by the end of this year, with final data reported in April 2022.
The China NMPA’s Center for Drug Evaluation accepted Lepu Biopharma Co. Ltd.’s new drug application (NDA) for anti-PD-1 antibody candidate HX-008 (pucotenlimab). That comes after the company filed for an IPO in Hong Kong.
Junshi Biosciences Co. Ltd. entered an agreement with Immorna Biotechnology Co. Ltd. to establish a joint venture (JV) as part of its efforts to expand into the mRNA sector.
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