media – Page 28 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

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
GB19 Injection Approved for Clinical Trials of Cutaneous Lupus Erythematosus

Kexing Biopharmaceutical(688136) announced on March 4 that its wholly-owned subsidiary, Shenzhen Kexing Biopharmaceutical Co., Ltd., has independently developed an innovative drug targeting BDCA2 (blood dendritic cell antigen 2).The drug “GB19 Injection” received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration, which approved it to conduct clinical trials for the indication of cutaneous lupus erythematosus (CLE). According to the announcement, GB19 injection targets BDCA2, a target specifically expressed on the surface of plasmacytoid dendritic cells (pDCs), and its mechanism of action differs significantly from existing clinical drugs targeting the B cell pathway. By specifically binding to BDCA2, it can inhibit the production of type I interferon by pDC cells, intervening in the abnormal activation loop between innate and adaptive immunity. Preclinical studies have shown that GB19 possesses good in vitro activity, immunogenicity, high bioavailability, and maintains target inhibition for over 90 days, exhibiting excellent safety profile. ...
- Source: drugdu
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- March 4, 2026
First patient dosing completed for KRAS G12D inhibitor ABSK141

On the morning of March 4th, Heyu -B (02256) announced that its subsidiary, Shanghai Heyu Biopharmaceutical Technology Co., Ltd., has successfully completed the first patient dosing in a Phase I/II clinical trial of its oral, highly effective, and selective small molecule KRAS G12D inhibitor, ABSK141, for patients with advanced solid tumors harboring KRAS G12D mutations. This progress marks a significant milestone for Heyu Pharmaceuticals in the field of KRAS-targeted therapy, and is expected to provide a transformative potential treatment option for patients with KRAS G12D-mutated solid tumors. According to the announcement, KRAS is one of the most common oncogenes in human cancers, with G12D being the major mutation subtype, widely found in various solid tumors such as pancreatic ductal adenocarcinoma, colorectal cancer, and non-small cell lung cancer. Because G12D mutations lead to specific conformational changes in the KRAS protein, it has long been considered an “untreatable” target, and currently, no ...
- Source: drugdu
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- March 4, 2026
China Sino Biopharmaceutical Signs Exclusive Licensing Agreement with Sanofi for Rofalcitinib

On March 4, Sino Biopharmaceutical Limited (1177.HK) announced that it has entered into an exclusive licensing agreement with Sanofi for rofalcitinib, a first-in-class, novel and potent oral small-molecule JAK/ROCK inhibitor. Under the agreement, Chia Tai Tianqing, a subsidiary of Sino Biopharmaceutical, grants Sanofi an exclusive license for the global development, manufacturing and commercialization of rofalcitinib. Sino Biopharmaceutical is eligible to receive up to **US$1.53 billion** in payments, including a US$135 million upfront payment, as well as potential development, regulatory and sales milestone payments. In addition, the company will receive tiered royalties at up to double-digit percentages based on the annual net sales of rofalcitinib. The agreement is subject to customary closing conditions, including approval from relevant regulatory authorities. Xie Qirun, Chairman of the Board of Directors of Sino Biopharmaceutical, stated: “We are delighted to join hands with Sanofi to bring the first-in-class JAK/ROCK inhibitor to patients worldwide. This collaboration represents ...
- Source: drugdu
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【EXPERT Q&A】Can multiple manufacturing enterprises be entrusted to produce medical devices?

Drugdu.com expert’s response: Chinese Current Regulations Have Lifted the “Only One Contract Manufacturer” Restriction Medical device registrants/filers may entrust multiple qualified enterprises to manufacture products. I. Regulatory Basis Regulation on the Supervision and Administration of Medical Devices (Order No. 739) Registrants/filers may entrust qualified enterprises to manufacture medical devices; no limit on the number of contract manufacturers. Measures for the Supervision and Administration of Medical Device Production It explicitly allows registrants to entrust multiple manufacturers. A quality and risk capability assessment shall be conducted for each entrusted enterprise; a delegation agreement + quality agreement shall be signed and supervision shall be implemented. NMPA Announcement No. 38 of 2024 Supports multiple entrustment and requires the registration certificate to list all entrusted manufacturers. II. Two Common Models 1. Multiple Entrustment for Finished Products (Multi‑source Supply) Entrust the same finished product to multiple manufacturers to expand ...
- Source: drugdu
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- March 4, 2026

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