華源證券：康方生物 HARMONi 數據進一步更新 維持 “買入” 評級

According to the Zhitong Finance APP, Huayuan Securities released a research report stating that it maintains a "Buy" rating for AKESO (09926), expecting the company's operating revenue for 2025-2027 to be 3.419 billion, 5.598 billion, and 8.577 billion yuan respectively. Using the DCF method, assuming a perpetual growth rate of 3% and a WACC of 7.06%, the company's reasonable equity value is HKD 187.5 billion (with an exchange rate of 1 RMB = 1.07 HKD). Given the company's outstanding innovation pipeline and strong commercialization, the clarity of overseas clinical certainty is gradually improving.

AKESO released its 2025 semi-annual report, achieving revenue of 1.412 billion yuan in H1 2025, a year-on-year increase of 37.75%, with a net profit attributable to the parent of -570 million yuan; R&D expenses were 731 million yuan, a year-on-year increase of 23.06%, sales expenses were 670 million yuan, a year-on-year increase of 29.84%, and management expenses were 134 million yuan, a year-on-year increase of 34.00%. In addition, AKESO announced overseas data for Ivosidenib at the 2025 WCLC conference, showing further improvement in OS, with an OSHR of 0.78, and an OSHR of 0.70 in the North American population, which is even more prominent.

Commercialization is steadily growing, with the performance growth driven by the volume increase of Ivosidenib and Cadonilimab. Benefiting from the rapid volume increase of the two core bispecific antibodies, Cadonilimab and Ivosidenib, after entering medical insurance, the company achieved revenue of 1.412 billion yuan in H1 2025, a year-on-year increase of 37.75%. In terms of product sales revenue, the sales revenue was 1.401 billion yuan, a year-on-year increase of 49.20%, indicating smooth commercialization progress. With subsequent product approvals and new indications, the company continues to make efforts in oncology, autoimmune diseases, metabolism, and other fields, which is expected to bring sufficient performance increments.

The WCLC conference updated OS data for Ivosidenib, showing more significant benefits for the North American population. On September 7, 2025, local time, AKESO's independently developed world-first PD-1/VEGF bispecific antibody Ivosidenib's overseas partner Summit Therapeutics released the updated data of the first global multicenter Phase III clinical HARMONi study at the World Lung Cancer Conference (WCLC 2025): 1) The OS of the HARMONi study further improved, HR=0.78 (P=0.0332), showing a significant improvement trend compared to the previous analysis results in May; 2) The OSHR for the North American population is 0.70; 3) The HARMONi study has achieved clinically meaningful and statistically significant PFS results; in the HARMONi study, the clinical research endpoints including OS and PFS for Western and Asian patients were highly consistent, and also highly consistent with the clinical research data of HARMONi-A.

The firm believes that as the follow-up time extends, the survival benefit trend of Ivosidenib is developing positively, adding strong leverage for the successful FDA approval of Ivosidenib. Currently, the ongoing clinical trials for Ivosidenib include: 1) Lung cancer, first-line NSCLC, first-line sq-NSCLC, NSCLC progressing after EGFR-TKI treatment, first-line PD-L1 positive NSCLC, first-line PD-L1 high expression NSCLC, etc.; 2) Others, first-line biliary cancer, first-line PD-L1 positive head and neck squamous cell carcinoma, first-line TNBC, first-line pancreatic cancer, etc Pay attention to the follow-up progress of the expansion of indications for Ivosidenib