ANKE BIO(SZ:300009) Quan Jing Wang·2025-12-29 10:19Core Viewpoint - Anhui Anke Biotechnology (Group) Co., Ltd. is set to experience a peak in new drug launches in 2026, with a dual focus on self-developed innovative drugs and agency-represented blockbuster products, covering key therapeutic areas such as oncology, rare diseases, and assisted reproduction, which will reshape the company's performance growth pattern [1] Group 1: Self-Developed Drugs - The long-acting growth hormone pipeline is expanding, with the collaboration with Weisheng Pharmaceutical on Longpei Growth Hormone entering the production review stage, expected to launch between late 2025 and early 2026, significantly improving patient compliance with a once-weekly dosing frequency [1] - Two major self-developed products are anticipated to achieve market breakthroughs in 2026: PA3-17 injection, a CD7 CAR-T therapy for T-lymphoblastic leukemia/lymphoma, is included in the CDE's breakthrough therapy category, with a pivotal Phase II trial starting in October 2025 and a conditional market application expected around 2026 [2] - An anti-VEGF humanized monoclonal antibody has completed Phase III clinical trials and plans to submit for market approval in 2026, providing an important treatment option for advanced malignant tumors [2] - The HER2-targeted innovative drug HuA21 injection has completed Phase Ib/II clinical trials and aims to advance to Phase III clinical application in 2026, potentially overcoming existing treatment resistance in HER2-positive breast cancer [2] Group 2: Agency-Represented Drugs - The long-acting follicle-stimulating hormone "Shengnuo" is highlighted as China's first approved long-acting follicle-stimulating hormone injection, developed through a collaboration between Anke Biotechnology and Baoji Pharmaceutical, achieving a convenient "one injection covers one week" treatment [3] - Phase III clinical trials show that key indicators such as the number of eggs retrieved and live birth rates are comparable to short-acting formulations, with the average injection frequency reduced to 2.6 times [3] - A dedicated promotion team of 300 has been established, with expectations for significant revenue contributions in 2026, filling a market gap in the domestic long-acting follicle-stimulating hormone sector, which has a market size exceeding 6 billion yuan [3] Group 3: Overall Impact - Anke Biotechnology's robust positioning in growth hormones, anti-tumor, and assisted reproduction fields has established a dual product matrix of "self-developed + agency" [3] - The concentrated launch of multiple new drugs in 2026 is expected to enrich clinical treatment options, enhance the accessibility of domestic drugs, and potentially drive the company's performance to achieve exponential growth, solidifying its core competitiveness in the biopharmaceutical niche [3]