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加科思-B(01167.HK):KRAS G12C抑制剂关键性临床获批开展

Gacos-B (01167.HK): KRAS G12C inhibitor approved for key clinical trials

國金證券 ·  Sep 7, 2022 00:00  · Researches

Incident On September 6, 2022, the company announced that the candidate KRAS G12C inhibitor JAB-21822 was approved by the NMPA for second-line and above advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutations. Comment KRAS G12C inhibitors have been approved for key clinical trials, and we look forward to subsequent NDA submissions. (1) JAB-21822 is an inhibitor developed for the KRAS G12C mutation type. This time, it was approved for carrying out a multicenter, single-arm, open-label phase II study on NSCLC patients. (2) The company previously announced phase I clinical data at the ASCO conference. Among non-small cell lung cancer patients treated with G12C mutations, the objective response rate was 56.3%, and the disease control rate was 90.6%. JAB-21822 has shown good tolerability and has the potential to have better dosage characteristics compared to competing products. For JAB-21822, the company is simultaneously exploring the curative effects of single drugs and combination drugs in China, the United States, and Europe. In addition to NSCLC, single drugs are also being investigated clinically for pancreatic duct cancer and colorectal cancer. Combined use includes clinical trials with EFGR monoclonal antibodies and the company's self-developed SHP2 inhibitor JAB-3312. (3) The company has a rich layout for KRAS targets, and pipeline reserves JAB-22000 for KRAS G12D and JAB-23400 for KRASmulti. Expected to submit an IND application in 2023, JAB-23400 is the company's first oral bioactive inhibitor that can inhibit multiple mutation types including KRAS G12X, G13D, and Q61H. SHP2 is leading the way in R&D, and the potential for joint development strategies is showing. (1) The company has stocked two SHP2 inhibitors JAB-3068 and JAB-3312 developed using a modified binding site drug design platform, and successfully authorized AbbVie to commercialize it outside of mainland China, Hong Kong and Macau. (2) SHP2 inhibitors focus on combined development, and clinical use with ① KRAS G12C ② EGFR ③ PD-1 inhibitors is being developed for the treatment of non-small cell lung cancer. (3) Clinical progress has been made in combination with KRAS G12C: the global phase I clinical trial completed the dose escalation portion; the Chinese phase I/IIa clinical obtained IND approval. The first patient administered the drug in May and local reactions were observed. Profit forecast and investment advice We maintain our profit forecast. We expect the company's revenue to be 0.17/0.19/0.31 billion yuan in 2022/23/24, up 10.72%/11.76%/63.16% year over year. Maintain a “buy” rating. Risk indicates the risk that a product will not be launched as expected; the risk of candidate product development failure; and the risk of a shortage of R&D expenses.

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