Research Express | Anke Bio hosts over 30 institutions for research, Trastuzumab revenue doubles, R&D investment increases by over 20%

Basic Research Overview

2025 Performance and Business Highlights

During this research, the company’s Board Secretary Mr. Li Kun and CFO Mr. Hu Chenghao first introduced the 2025 operating results. Data shows that the company achieved a net profit of 747.3387 million yuan for the year, a year-over-year increase of 4.40%; net profit attributable to shareholders of the listed company was 735.1927 million yuan, up 4.00% year-over-year. Despite industry-wide pressure and dual challenges from policies and markets, the company achieved growth in both revenue and net profit, mainly thanks to the rebound in core product sales and improvements in internal refined management.

Specifically, core products: gene therapy drugs increased by 7.38% year-over-year, reversing last year’s decline; blood circulation and pain relief patches grew by 16.75%; the commercialization of trastuzumab (brand name: Ansertin®) accelerated, with sales revenue in 2025 increasing significantly by 108.33% year-over-year. Meanwhile, the company reduced costs and increased efficiency, with management expenses down 9.77% year-over-year; R&D investment increased by 20.52%, supporting innovation. Additionally, the company completed the divestment of forensic business, shrinking non-core segments, and reached strategic cooperation with Baojing Pharmaceutical (2659.HK) and Weisheng Pharmaceutical (2561.HK), laying out long-acting follicle-stimulating hormone alpha N01 injection (Shengnuowa®), and injection of Longpe Growth Hormone (brand name: Weizhen Gao®) in the assisted reproduction and growth development fields.

Core Issues and Company Responses

Weizhen Gao®: Progress in Registration Access and Market Deployment

Regarding the registration approval process and market strategy for Weizhen Gao®, the company stated that this product, as the world’s only long-acting growth hormone proven superior to Japanese formulations through clinical trials, is currently positioned in the high-end market during importation, focusing on “optimal efficacy.” The local production technology transfer with WuXi Biologics is underway, expected to be approved by 2028. After commercialization, the product’s competitiveness will further improve, potentially attracting more patients.

In vivo CAR-T Field: Dual-platform Layout, Active Clinical Progress

In the in vivo CAR-T field, the company’s invested firms Bosengji and Afana are both involved. Afana’s in vivo CAR-T using LNP delivery has entered investigator-initiated clinical trials (IIT); Bosengji’s CD19 LV009 injection, utilizing innovative in vivo lentivirus transfection technology, has shown high-efficiency transfection of resting T cells in preclinical studies, with two patients enrolled in IIT studies. Additionally, Bosengji Anke’s PA3-17 injection (CD7-CART) has been included in breakthrough therapy designation, currently in critical Phase II trials, with plans to complete patient enrollment within a year. Six patients have been enrolled so far, five of whom achieved CR; if progress continues smoothly, a pre-NDA communication application may be submitted by the end of 2026, aiming to be the first domestically marketed product in this field.

Trastuzumab: Rapid Sales Growth, Clear 2026 Goals

Regarding the promotion of trastuzumab (Ansertin®), the company introduced that after approval at the end of 2023, sales revenue in 2025 increased by 108.33% year-over-year, achieving profitability for the product. For potential policy adjustments in 2026, the company stated that if not included in national centralized procurement, they will actively expand the market; if included, as a latecomer, they are expected to benefit significantly. Some regional distribution channels have already been adjusted to dealer models, with sales targets for 2026 set for substantial growth in both revenue and profit.

Chinese Patent Medicine and Polypeptide Raw Material Drugs: Steady Growth Expected in 2026

In the Chinese patent medicine sector, 2025 saw a 16.75% increase in blood circulation and pain relief patches. The sugar-free snake gall川贝液 (a proprietary product) benefits from stable raw material supply, and the company is advancing the development of similar products and optimizing traditional Chinese medicine rubber paste processes, expecting steady growth in 2026. The polypeptide raw material drug sector has been under pressure due to centralized procurement in recent years; the company is developing polypeptide formulations to create a “raw material + formulation” synergy, and leveraging Shanghai Innovation Research Institute to develop innovative polypeptide drugs to improve performance.

Other Innovation Pipeline Progress

Bispecific antibody HK010 (PDL1×4-1BB) is currently in Phase Ib/IIa clinical trials, with some safety studies completed and efficacy exploration underway. Bosengji’s in vivo CAR-T platform is engaging with overseas companies at international conferences, reaching strategic cooperation agreements with two firms. Its technological advantages include high tissue specificity, efficient transfection of resting T cells, and excellent pharmacokinetics.

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Editor: Xiaolang Kuaibao