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Henlius’s potential best-in-class small molecule drug receives its first clinical trial approval

On March 4, the CDE (Center for Drug Evaluation) website showed that Henlius’ HLX97 clinical trial application was approved for the treatment of advanced/metastatic solid tumors. This is the third domestically produced KAT6A/B inhibitor to receive clinical trial approval. Source: CDE Official Website HLX97 is a novel, potentially best-in-class oral histone acetyltransferase (KAT6A/B) inhibitor . KAT6A/B is a highly promising target for the treatment of solid tumors such as breast cancer, and its abnormalities are closely associated with the development and progression of various hematologic malignancies and solid tumors. HLX97 regulates the proliferation, differentiation, and apoptosis of tumor cells by precisely inhibiting the activity of KAT6A/B. It has pharmacokinetic characteristics of rapid onset and rapid clearance and high selectivity. It aims to maximize the anti-tumor activity of the drug while reducing the blood toxicity of the product, and is expected to bring new treatment options to patients with cancers such ...
- Source: drugdu
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- March 5, 2026
New anti-aging drug approved for clinical trials

On March 2nd, RC017 , an innovative drug developed by Nanjing Ruichu Pharmaceuticals targeting the mechanisms of aging to treat eye diseases , officially received FDA approval for clinical trials in the United States. Notably, this is the first time in FDA history that a Chinese anti-aging innovative drug clinical trial application has been approved. RC017 is one of the core pipelines of Ruichu Pharmaceuticals, focusing on “targeting aging mechanisms.” The company employs a unique “three-platform R&D strategy,” focusing on key biological pathways such as chronic inflammation, clearance of senescent cells, and cell reprogramming. Research shows that with age, the common molecular basis of many degenerative diseases converges on chronic inflammatory pathways, and the RC series of drugs is based on the identification and intervention of emerging first-in-class inflammation-related targets. Founded in June 2021 and headquartered in Nanjing, Ruichu Pharmaceuticals is a leading Chinese company focused on the biology of ...
- Source: drugdu
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- March 5, 2026
First in the world and first in China, Yahong Pharmaceutical’s non-invasive treatment for cervical precancerous lesions, Cervita, has been approved

(China, March 3, 2026) Asarum Pharmaceuticals (stock code: 688176.SH), a global innovative pharmaceutical company focusing on urogenital tumors and women’s health, announced that its core product APL-1702 (trade name: Cevira®, generic name: Hexyl valerate hydrochloride ointment for cervical photodynamic therapy) has received a Drug Registration Certificate issued by the National Medical Products Administration of China, officially approving its market launch. This product is the world’s first non-surgical, non-invasive treatment for patients with cervical intraepithelial neoplasia grade 2 (CIN2), filling a clinical gap in this treatment area and redefining a potentially huge blue ocean market for non-invasive treatments. Currently, cervical cancer remains a major threat to women’s health worldwide. According to a 2023 market survey, the number of patients with high-grade squamous intraepithelial lesions (CIN2) diagnosed by histopathology in my country exceeds 700,000, of which approximately 60% are CIN2. It is projected that the incidence, screening rate, and diagnosis rate will ...
- Source: drugdu
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- March 5, 2026
Its investee company’s PA3-17 injection has received clinical approval for a new indication, expanding the applicable population to children and adolescents

Anke Biotechnology(300009) announced on the evening of March 4 that its investee companies, Boshengji Pharmaceutical Technology (Suzhou) Co., Ltd. and Boshengji Anke Cell Technology Co., Ltd. (collectively referred to as “Boshengji Anke”), received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration. The application for a new indication for its independently developed PA3-17 injection was approved, and it was agreed to conduct clinical trials for the treatment of relapsed/refractory T-lymphoblastic leukemia/lymphoma in children and adolescents. PA3-17 injection is the world’s first CD7-targeting autologous CAR-T cell therapy product independently developed by Boshengji Anke and approved for clinical trials. It has been included in the “Breakthrough Therapy” list by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. The product is currently undergoing a pivotal Phase II clinical trial for adult patients with relapsed/refractory T-lymphoblastic leukemia/lymphoma. The approval of this clinical trial for PA3-17 injection ...
- Source: drugdu
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- March 5, 2026
Subsidiary’s Imicizumab Injection Receives Clinical Trial Approval

Xin Nuowei(300765) announced on the evening of March 4 that its controlling subsidiary, CSPC Jushi Biopharmaceutical Co., Ltd., recently received a “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration for emecizumab injection (SYS6053), agreeing to conduct clinical trials as a biosimilar of emecizumab. SYS6053 is a modified humanized IgG4 monoclonal antibody with a bispecific antibody structure that bridges coagulation factors IXa and X. It is a biosimilar of the original drug, Shuyoule®, and is indicated for patients with hemophilia A. This product is classified as a therapeutic biological product .For Category 3.3 applications, the research and development follows the relevant guidelines for biosimilars. Pharmaceutical and non-clinical research results show that the biosimilar is highly similar to the original reference drug in terms of quality, safety and efficacy, supporting the conduct of subsequent clinical studies. Xin Nuowei notes that after obtaining clinical trial approval, drugs still need ...
- Source: drugdu
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- March 5, 2026
TOKYO INTERPHEX Week

Organiser：Reed Exhibitions Time：May 20 – 22, 2026 Address：3-21-1 Ariake, Koto-ku, Tokyo 135-0063, Japan Exhibition hall：Tokyo Big Sight International Exhibition Center Product range: Biomaterials: Amplification equipment, DNA extraction equipment, proteome extraction and purification, DNA analysis equipment, proteome analysis equipment, nuclear magnetic resonance (NMR), automated workstations, automatic dispensers, cell analysis equipment, incubators, cold storage, nutrient media, stirrers, pipettes, assay kits, regenerative medicine, drug development, biomaterials, biological contracts, pharmaceutical intermediates, cosmetic ingredients, fine chemicals, additives, excipients, plant extracts. Instruments & Equipment: Analytical instruments, laboratory equipment and accessories, chemical reagents. Bioengineering: Bioprocessing, biochemistry, biotechnology and products, analytical methods, nanobiotechnology and products, optics and technology. Bioinformatics & Services: Bioinformatics, biotechnology services. Medical & Pharmaceutical Applications: Medicine and pharmaceuticals, biologics, biosimilars and biobetters. Environmental Applications: Environmental biotechnology, agricultural applications, agricultural products / plant biotechnology, animal husbandry. Pharmaceutical Excipients: Pharmaceutical packaging materials, pharmaceutical excipients, excipient-related equipment; Excipients: antimicrobial preservatives, antioxidants, capsules / encapsulation, coating agents, colors and dispersions, drug delivery systems, emulsifiers / ...
- Source: drugdu
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- March 5, 2026
Gusekirumab Injection Accepted by CDE, Multiple Pipelines Advancing Simultaneously

Abstract : On March 3, 2026, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced on its official website that the clinical trial application for Gusekimumab injection (acceptance number: CXSL2600293), independently developed by Nanjing Shunxin Pharmaceutical Co., Ltd., a subsidiary of Chia Tai Tianqing Pharmaceutical Group, had been formally accepted, with a registration category of Class 3.3 biological products. At the same time, several other Class 1 innovative biological drugs independently developed by Chia Tai Tianqing, including the HER2 bispecific antibody TQB2930, the HER2 dual-epitope ADC TQB2102, and the EGFR/c-Met bispecific antibody TQB2922, also appeared frequently on the CDE’s acceptance list, demonstrating the company’s strong R&D capabilities in the field of biological drugs. picture I. Gusekimumab Injection: Targeting IL-23, Expanding into the Autoimmune Field On March 3, the CDE (Center for Drug Evaluation) updated its “Accepted Drug Information” section, showing that Chia Tai Tianqing Pharmaceutical ...
- Source: drugdu
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- March 4, 2026
Yifan Pharmaceutical’s teriparatide injection has been accepted by the CDE (Center for Drug Evaluation), adding a new domestic player to the osteoporosis treatment field

Abstract : On March 3, 2026, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced on its official website that the clinical trial application for teriparatide injection (acceptance number: CXSL2600294), independently developed by Yifan Pharmaceutical (Shanghai) Co., Ltd., has been formally accepted, and its registration category is Class 3.3 biological products. As the world’s first approved bone-forming anti-osteoporosis drug, the domestic research and development process of teriparatide has accelerated again, and it is expected to provide more accessible treatment options for osteoporosis patients at high fracture risk in China. picture I. CDE Acceptance: Domestic Teriparatide Achieves New Progress On March 3, the CDE (Center for Drug Evaluation) updated its “Accepted Product Information” section, showing that the clinical trial application for teriparatide injection submitted by Yifan Pharmaceutical (Shanghai) Co., Ltd. has been accepted. The drug type is therapeutic biological product, and the application type is new ...
- Source: drugdu
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- March 4, 2026
//news.yaozh.com/archive/47318.html PD-1 sales surge

Recently, TopAlliance Biosciences released its 2025 preliminary financial results, reporting total revenue of RMB 2.498 billion, a 28.23% increase year-on-year ; net profit attributable to shareholders of the parent company was RMB -874 million, and net profit attributable to shareholders of the parent company after deducting the impact of share-based payments was RMB -798 million, representing a 37.70% reduction in losses year-on-year. TopAlliance Biosciences stated that in 2025, the company continued to implement the “Improving Quality, Efficiency and Returns” action plan. While significantly improving its commercialization capabilities, the company continuously strengthened cost control and resource focus, and made efficient investments to reduce unit production costs and improve sales efficiency, resulting in a reduction in losses compared to the same period last year . The sales revenue of the core product, toripalimab injection, in the domestic market increased significantly by approximately 37.72% year-on-year, which was the main driver of revenue growth. ...
- Source: drugdu
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- March 4, 2026
A major breakthrough! Roche’s oral BTK inhibitor achieves its third Phase III clinical trial victory, a game-changer in the multi-billion dollar MS (manufactured pharmaceuticals) market.

On March 2, Roche officially announced that its investigational BTK inhibitor, fenebrutinib, successfully met its primary endpoint in the pivotal Phase III clinical trial (FENhance 1) for relapsing-remitting multiple sclerosis (RMS). This means that all three pivotal Phase III clinical trials of fenebrutinib have been successfully completed, giving Roche a significant advantage. Image source: Roche official website According to information disclosed by Roche, in patients with relapsing multiple sclerosis (RMS), fenetinib significantly reduced the annual relapse rate (ARR) by 51% compared to teriflunomide, with a treatment duration of at least 96 weeks. This result echoes the 59% ARR reduction reported in the previous FENhance 2 study; Roche even provided a striking conversion: the two studies combined roughly equate to “one relapse every 17 years.” Multiple sclerosis (MS) is a chronic autoimmune disease in which the patient’s immune system mistakenly attacks the myelin sheath of the central nervous system (brain and ...
- Source: drugdu
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- March 4, 2026

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