Shen Wan Hongyuan: Maintaining the Reputation-B (02256) “Buy” Rating, the first self-developed new drug was approved for marketing

The Zhitong Finance App learned that Shen Wan Hongyuan released a research report saying that on December 22, Heyu-B (02256) announced that the CSF-1R inhibitor pimitinib was approved for marketing by the China Drug Administration for surgical removal of adult patients with symptomatic tenosynovial cytoma (TGCT) that may cause functional limitations or serious complications. The first self-developed new drug was approved for marketing, beginning a new commercialization journey. At the same time, it is progressing steadily in the research pipeline, achieving a virtuous cycle of “self-hematopoiesis” and maintaining a “buy” rating.

Shen Wan Hongyuan's main views are as follows:

The first self-developed new drug pimitinib is on the market. Merck will drive the commercialization process in the future

Pimitinib (trade name: Betgemax) is an oral, highly selective, and highly effective small-molecule CSF-1R inhibitor independently developed by the company. In previous global phase III ALVER study results, pimitinib showed the best ORR in its class, and the safety advantages were obvious. Long-term follow-up data published at ESMO (European Society of Medical Oncology) in 2025 showed that in patients treated with pimitinib at 14.3 months of median follow-up, ORR increased significantly from 54% at 25 weeks to 76.2%, with 4 cases achieving complete remission. The product just now is the company's first new drug approved for marketing. It has previously reached an exclusive commercial cooperation with Merck, and after approval, Merck will promote the commercialization of this product as soon as possible. With the differentiated advantages of pimitinib in terms of product strength and Merck's strong global commercialization capabilities, the bank is optimistic about the quantity of this product after launch.

Preliminary backline data on oral small molecule PD-L1 inhibitors in combination with vormetinib have been released

On December 8, at the 2025 ESMOAsia Conference (Asian Annual Meeting of the European Society of Oncology Medicine), phase II data on ABSK043 combined with vormetinib to treat advanced non-small cell lung cancer with EGFR mutations and PD-L1 positivity showed good safety and tolerability. Based on these results, the China Drug Administration agreed to conduct first-line treatment studies of this program. Previous studies have shown that in EGFR mutations combined with high PD-L1 expression, the combination regimen of PD-1/PD-L1 monoclonal antibody and EGFR-TKI is limited due to serious toxic side effects. The company's small molecule joint program showed initial positive results and is expected to change the treatment difficulties of this population.

A number of pipelines are progressing steadily. Recently, the company announced a number of developments in the research pipeline: ① The company's IND application for the small molecule KRAS G12D inhibitor ABSK141 was approved by the China Drug Administration, and the product showed potential best-in-class oral bioavailability in pre-clinical studies; ② the FGFR2/3 inhibitor ABSK061 completed the first patient administration in a phase II clinical trial to treat achondroplasia in children. This product is the first FGFR2/3 selective inhibitor to enter clinical trials, which is expected to achieve better clinical safety windows and curative effects.

Profit forecast: The bank maintains its previous profit forecast. Net profit due to mother is expected to be 63 million 151 million and 133 million respectively in 2025-2027, corresponding PE is 131X/55X/62X.

Risk warning: risk of R&D failure or falling short of expectations; risk of performance fluctuations; risk of worsening competition.