Main points of investment

Orebatinib's sales reached 95.93 million yuan from its listing to the end of June this year, and commercialization has entered an accelerated period:

From the end of November last year when it was approved for listing to the end of June this year, Orebatini's sales reached 95.93 million yuan.

Considering (1) the inclusion of the 2022 edition of the guidelines for diagnosis and treatment of CSCO malignant Hematological Diseases and the guidelines for Integrated diagnosis and treatment of tumors in China, (2) the coverage of Huimin Insurance in 34 cities in as many as 10 provinces and cities, and (3) the acceptance of NDA for the treatment of drug-resistant and / or intolerant CML in first-and second-generation TKI, and the indication is expected to be fully approved, the process of commercialization is expected to accelerate. In addition, the company and Tanner have launched an innovative patient-specific Drug use Program (NPP) that will support Orebatinib to provide access to the drug to designated patients in more than 130 countries that have not yet been approved for marketing.

Clinical development is progressing smoothly, and many milestones are worth looking forward to: in the first half of the year, the company released clinical data of APG-2575 in Chinese CLL/SLL patients at ASCO. ORR reached 67.4%, and the tolerance was good, adverse events were controllable, no dose-limiting toxicity was observed at the highest dose of 800mg, and the risk of tumor lysis syndrome (TLS) was extremely low under daily dose increasing administration. At the same time, the company published phase 1 clinical data of APG-2575 in Chinese NHL patients on EHA; of the 11 assessable CLL patients, 8 were assessable in the 200mg or higher dose group, with ORR as high as 87.5%, of which 3 were CR. In addition, the company announced on ASCO that APG-115 combined with Pablizumab (K) has proven efficacy in patients with IO-resistant or recurrent melanoma, including 11% of ORR, 2 cases of CR and 57% of DCR. The company expects to complete the APG-2575 treatment of CLL/SLL registered clinical patients in the first half of 2023. At the same time, the company is actively promoting communication with FDA on global key registered phase 2 clinical trials, including Orebatinib, APG-2575 and APG-115.

There is plenty of cash on hand, which is basically the same as at the end of last year: the R & D expenditure in the first half of the year increased slightly to 340 million yuan from 320 million yuan in the same period last year. The net loss increased slightly to 410 million yuan from 380 million yuan last year. As of June 30, the company had cash and cash balance of about 1.7 billion yuan on hand, which was basically the same as that at the end of last year, mainly due to bank loans of about 470 million yuan in the first half of the year.

Risk tips: research and development progress is not as expected, market competition intensifies, policy risks and so on.