Event

On March 25, 2022, the company announced that the self-developed CD73 monoclonal antibody candidate JABBX102 has received IND approval from the State Drug Administration and will start a phase I clinical trial in patients with advanced solid tumor in China.

Comment

Based on the allosteric site inhibitor platform, research and development helps to promote the clinical breakthrough of "difficult drug targets". 1) CD73 is an important target of tumor adenosine pathway, and no drug has been approved for this target in the world. Preclinical data show that JAB-BX102 has dose activity and has the potential to treat solid tumors. In addition, JAB-BX102 was approved by FDA for phase Ⅰ / Ⅱ a clinical trials in October 2021. 2) the company reserves two SHP2 inhibitors, JAB-3068 and JAB-3312, developed with the aid of allosteric binding site drug design platform, and authorizes Aberdeen to commercialize outside mainland China, Hong Kong and Macau. 3) Clinical progress of JAB-3068: in the United States, the clinical phase of single drug Ⅰ was basically completed. The maximum tolerable dose and RP2D have been determined; in China, phase an of single-drug Ⅱ has been completed, and Ⅱ an is expected to be completed in the second half of 2022; and the first patient administration of combined PD-1 in the treatment of advanced solid tumors was completed in April 2021. 3) Clinical progress of JAB-3312: dose exploration for patients with Ⅰ phase solid tumor was completed in China and the United States, and the maximum dose and RP2D were determined. The Ⅰ / Ⅱ phase trial in combination with KRAS G12C inhibitor, PD-1 monoclonal antibody, EGFR inhibitor and MEK inhibitor was launched in China and the United States.

The target layout of KRAS is comprehensive, and the candidate drug JAB-21822 is expected to be submitted to NDA in 2023.

1) there are four KRAS inhibitors in the research pipeline, namely JAB-21822, JAB-22000, JAB-23000 and JAB-23400. 2) the research and development of JAB-21822 for G12C mutation is in the clinical stage. In head-to-head animal experiments with Amgen Inc and Mirati KRAS G12C inhibitors, JAB-21822 showed excellent competitive characteristics and good tolerance, and had better dose characteristic potential compared with competitive products. 3) Clinical progress of JAB-21822: phase a Ⅱ of monotherapy for non-small cell lung cancer in China will be submitted for registration in 2022, or may become the company's first commercial product; phase Ⅰ / Ⅱ of patients with advanced colorectal cancer treated with EGFR antibody cetuximab will complete FPI in February 2022.

Profit forecast and investment advice

According to the latest clinical progress, we have raised the revenue of 2022 JAB-21822 for 23 years, an increase of 13% and 12%. Assuming that it is commercialized in 2024, it is estimated that the annual revenue of 1.70 Universe in 2022-23-24 is 1.90 / 310 million yuan, an increase of 3.78%, 11.76% and 63.16% over the same period last year. Maintain a "buy" rating.

Risk hint

The risk of KRAS G12C inhibitors on the market is lower than expected; the risk of failure in the development of candidate products; the risk of shortage of R & D expenses.