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On July 21, the Drug Review Center (CDE) of the State Drug Administration of China announced that Kangfang Bio's class 1 new drug AK117 injection spution seision was declared for clinical trials and accepted by CDE.
this is a monoclonal antibody targeting CD47, which has previously been approved by IND in the United States and completed its first patient intake and administration in Australia in May this year.
note, CD47 has become a hot target for oncology immunotherapy, and earlier this month, Sessen Pharmaceuticals obtained an exclusive license for a immunotherapy targeting CD47-SIRP alpha in Greater China for up to $120 million.
CD47 antibody ZL-1201, independently developed by Reding Pharmaceuticals, was also recently approved for clinical practice in China.
screenshot source: CDE official CD47 is overexpressed in a variety of cancer cells.
CD47 is like a cell label "Don't eat me", when the protein expression level is high, macrophages will not swallow these cells, to avoid "mistakenly hurt" to normal cells.
previous studies have shown that both CD47 targeted therapy monodrug therapy and other immunotherapy use, for solid and hematomahave have good anti-tumor effect.
that's why this target is a hot topic for immunotherapy.
at present, China has a number of pharmaceutical companies are developing CD47 targeted therapy, involved in enterprises including Reding Pharmaceuticals, Cinda Bio, Hengrui Pharmaceuticals, Yiming Anke, Tianyi Biology and so on.
three anti-CD47 monoclonal antibodies have entered phase 1 clinical trials, and three disspecific antibodies targeting CD47 are in the early clinical phase.
, E.S. Pharmaceuticals earlier this month obtained an exclusive license from EpicentRx for RRx-001, an oncological immunotherapy that targets CD47-SIRP alpha, in Greater China.
, the product is currently in the overseas phase 3 clinical trial satcom on small cell lung cancer (SCLC) indications.
part of the CD47 targeted therapy Kangfang Biology was established in 2012, is committed to the development of first-in-class" and "best-in-class" innovative therapies, has been officially landed on the Hong Kong Stock Exchange in April this year.
the company has more than a dozen product pipelines, including PD-1/CTLA-4 double anti-AK104, a PD-1 antibody AK105, and potentially pioneering PD-1/VEGF double-anti-AK112.
References: China's National Drug Administration and the Official Website of the Drug Review Center. Retrieved Jul 21, 2020, from. #