Two marketing applications were approved, and the commercial product portfolio was extended to the non-oncology field for the first time: On September 30, the company announced that Ketanil was approved for first-line treatment of gastric cancer. This is the second indication that Ketanil has been approved in China. According to data from the International Agency for Research on Cancer (IARC), there were about 0.48 million new cases of gastric cancer in China in 2020, ranking third among all cancer types. Therefore, we expect that approval of this indication will significantly expand the potential target audience for ketanil. If health insurance negotiations are successful at the end of the year, it is expected that it will quickly enter hospitals next year and penetrate the target market with great potential. On the same day, the company's anti-PCSK9 inucimab (AK102) was approved for marketing in adult patients with essential hypercholesterolemia and mixed dyslipidemia who were unable to achieve LDL-C goals after receiving statins. This is the company's first commercial product in the non-oncology field, and the second domestically produced PCSK9 monoclonal antibody approved for marketing; as another competitor in the same marketing review stage was not approved, the current competitive pattern of the product is good. Based on the above approval, we raised the POS assumption for the corresponding indications to 100%, and the POS-adjusted peak sales forecast for Kaitani and Inussi was raised to 5.2 billion/1.2 billion yuan respectively.
Intensive publication of clinical data: In addition to the Evoxide head-to-head K drug research data announced at the WCLC conference (previous report), the company also recently published a number of important data at EADV, ESMO and other conferences. The recommendations focus on: 1) Phase II results of IL-17 gumocimab treatment for moderate to severe plaque psoriasis showed that the Gumoci treatment group significantly improved the response rate of PASI90, PASI75, and SpGA0/1 in week 12, and the efficacy was maintained until the 68th week. Previously, the key registered phase III clinical study of Gumoch in the treatment of moderate to severe plaque psoriasis had reached all efficacy endpoints, including PASI100 and SpGA0/1. 2) Excellent data from the Phase II study on first-line treatment of multiple solid tumors by Evosi was presented at the ESMO conference, including first-line MSS/PMMR mCRC (+ CD47), first-line TNBC, and first-line PD-L1+HNSCC (+ CD47), which is expected to further expand the clinical application space and extend the life cycle of the product.
Target price increase: We raised the company's 2024-26 revenue by 6-10% to reflect recent approval of new products/new indications and positive clinical developments. Our latest DCF target price is HK$87.0, corresponding to a potential increase of 26% over the next 12 months. Key catalysts include the status of health insurance negotiations between Ketanil and Ivorax, the progress of domestic marketing approval for new indications, and the progress of the Phase III overseas study of Evosi.
