Akeso Inc. became the fifth company to score an approval for a homegrown PD-1 antibody in China, with penpulimab cleared for relapsed or refractory (r/r) classic Hodgkin’s lymphoma (cHL). The company is seeking more approvals for nasopharyngeal and lung cancers in both China and the U.S. to stand out in the increasingly competitive PD-1 space.
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.
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.
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 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.
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.
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