According to the Insight database, in 2025, the development progress of over 2,600 new drugs (excluding improved new drugs and biosimilars) changed globally, with 20 companies having more than 15 drugs in clinical progress. Against a backdrop of fierce competition among global pharmaceutical companies, Sino Biopharmaceutical Limited (1177.HK), leveraging its strong R&D capabilities, advanced the development of 40 new drugs throughout the year, securing the 4th position in global new drug progress rankings and outperforming many multinational pharmaceutical giants. 

Data Description: Source: DXY Insight Database Global New Drugs module. Criteria: "Global Highest Stage" ≥ Phase I clinical (including clinical trials with unknown phases), "Project Status" is active, "Global Highest Status Time" is from January 1, 2024 to December 31, 2024, "Drug Type" is new drug (excluding improved new drugs and biosimilars), "R&D Institution" is company (excluding universities, hospitals, research institutes). Early-stage clinical = Phase I + Phase I/II; Late-stage clinical = Phase II, Phase II/III, Phase III; Marketing approval = Approved for marketing + Application for marketing. 

Among the more than 2,600 new drugs with clinical progress globally in 2025, 131 were approved for the first time, officially beginning their commercialization journey. Another 111 had marketing applications submitted, and over 250 were undergoing Phase III clinical trials. Driven by both in-house R&D and in-licensing, Sino Biopharmaceutical Limited saw progress in a total of 40 new drugs, nearly 10 more than in 2024. 

In terms of progress, Sino Biopharmaceutical Limited had two Class 1 new drugs approved for marketing. On December 9, 2025, Cumociclib Capsules (Saitanxin^®), the world's first CDK2/4/6 inhibitor, was officially approved in combination with Fulvestrant for the treatment of patients with HR+/HER2- locally advanced or metastatic breast cancer who have previously received endocrine therapy. As a new-generation triple CDK inhibitor independently developed by CTTQ Pharma, Cumociclib offers a novel treatment solution for clinical resistance to CDK4/6 inhibitors and for mitigating issues of myelosuppression. 

In August of the same year, Zongertinib Tablets (Hernexeos^®), jointly promoted in mainland China by Sino Biopharmaceutical Limited and Boehringer Ingelheim, was officially approved for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) activating mutations who have previously received at least one systemic therapy. As the world's first and currently only oral targeted drug approved in China for treating HER2-mutant advanced NSCLC, Zongertinib took only one year from the submission of its marketing authorization application in January 2025 to reaching patients, demonstrating the "China speed" of rapidly implementing innovative therapies. 

In 2025, Sino Biopharmaceutical Limited completed a total of five pharmaceutical deals. Among them, the acquisition of LaNova Medicines in July not only marked the first major domestic M&A deal in the innovative drug sector but also accelerated the innovative development of its own pipeline. Following the acquisition, LaNova Medicines' technology platforms, including bispecific antibodies and Antibody-Drug Conjugates (ADCs), were integrated into Sino Biopharmaceutical Limited, further strengthening the company's R&D capabilities in cutting-edge molecular types and tumor immunology, and re-accelerating the company's comprehensive innovation and international business. 

In 2025, Sino Biopharmaceutical Limited made comprehensive efforts in biologic drug types such as bispecific antibodies, PROTACs, and ADCs. During the year, three bispecific antibodies entered the Phase III clinical stage: the HER2 bispecific antibody TQB2930, the PD-1/TGFβ bispecific antibody TQB2868, and the CD3/CD20 bispecific antibody TQB2825. In addition, three Proteolysis-Targeting Chimeras (PROTACs) and four Antibody-Drug Conjugates (ADCs, including bispecific ADCs) are undergoing early-stage clinical trials. In 2025, a total of 18 new drugs received clinical trial approval for the first time, covering core therapeutic areas such as oncology, metabolism, surgery/analgesia, and respiratory diseases. 

Source: DXY Insight Database Official WeChat Account