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Wanshuan® (aniline profen injection) is Yiling Wanzhou’s first approved patented new chemical drug.

Announcement from Shijiazhuang Yiling Pharmaceutical Co., Ltd. Regarding the Obtaining of Drug Registration Certificate for Aniline Profen Injection by its Wholly-Owned Subsidiary The Company and all members of its Board of Directors guarantee the truthfulness, accuracy, and completeness of the information disclosed, and that there are no false records, misleading statements, or material omissions. Recently, Yiling Wanzhou International Pharmaceutical Co., Ltd. (hereinafter referred to as ” Yiling Wanzhou ” ) , a wholly-owned subsidiary of Shijiazhuang Yiling Pharmaceutical Co., Ltd. (hereinafter referred to as “the Company”), received approval from the National Medical Products Administration (NMPA) for its application for marketing authorization of anilineprofen injection submitted to the Center for Drug Evaluation of the NMPA, and obtained a drug registration certificate. The relevant information is hereby announced as follows: I. Basic Information about the Drugs Certificate Number : 2026S0076 Generic name of the drug: Anilineprofen Injection Product Name: Wan Shu An ...
- Source: drugdu
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- January 23, 2026
AbbVie’s “10 Billion Dollar Molecule” Receives Approval for New Indication in China

On January 22, AbbVie announced that risankizumab (trade name: Xikaiyue) has been approved in China for its second indication: the treatment of adult patients with moderate to severe active ulcerative colitis (UC) who have an inadequate, unresponsive, or intolerant attitude to conventional or biologic therapies. Risenzilumab is an IL-23 inhibitor that selectively blocks IL-23 by binding to the IL-23p19 subunit. IL-23 is a cytokine involved in the inflammatory process and is believed to be associated with many chronic immune-mediated diseases. On March 10, 2025, Risenzilumab was first approved for marketing in China for the treatment of adult patients with moderate to severe active Crohn’s disease who have an inadequate response, loss of response, or intolerance to conventional or biologic therapies.This approval for the new indication is based on the positive results of the INSPIRE and COMMAND Phase III clinical trials.The results showed that in the INSPIRE induction therapy trial, levosizumab ...
- Source: drugdu
- 114
- January 23, 2026
Verizon®, a PD-L1/4-1BB bispecific antibody, has received orphan drug designation in the European Union, potentially accelerating access to first-in-class therapy for patients worldwide.

On January 22, 2026, Nanjing Veolizhibo Biotechnology Co., Ltd. (hereinafter referred to as “Velizhibo” or the “Company”, stock code: 9887.HK) announced that its core product, Verizon® ( LBL-024, anti-PD-L1/4-1BB bispecific antibody), has been granted Orphan Drug Designation (ODD) by the European Commission (EC) for the treatment of extrapulmonary neuroendocrine carcinoma (EP-NEC). This is another important milestone in the global development of Verizon®. Currently , Verizon® has demonstrated first-in-class (FIC) or best-in-class (BIC) potential in Phase II or registrational clinical trials for three indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and EP-NEC . According to the EC definition, an orphan drug is a medicine used to diagnose, prevent, or treat a life-threatening or chronically debilitating disease, and the number of patients is no more than five per ten thousand of the total EU population. Obtaining orphan drug designation provides several key incentives, including but not limited to: ...
- Source: drugdu
- 69
- January 23, 2026
【EXPERT Q&A】How to apply for the quality management system verification of the registration of Class III medical devices within the territory?

Drugdu.com expert’s response: Application Process for Quality Management System Verification of Class III Medical Device Registration within China I. Submission of Registration Application and Verification Materials: The applicant must submit a quality management system verification application simultaneously with the Class III medical device registration application to the National Medical Products Administration (NMPA). Within 10 days of accepting the registration application, the NMPA will notify the corresponding provincial, autonomous regional, or municipal drug regulatory authority (provincial authority) to initiate the verification. II. Verification Notification and Material Preparation: Within 10 working days of accepting the application, the NMPA’s Center for Medical Device Evaluation (CMDE) will send the quality management system verification notification, relevant materials, and an electronic copy of the registration application form to the provincial authority. For cases involving cross-provincial contract manufacturing, the notification will only be sent to the provincial authority where the registrant is located, which shall then coordinate ...
- Source: drugdu
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- January 23, 2026
Recombinant Zoster Vaccine (Shingles Vaccine) Receives Clinical Trial Approval Notice

On the evening of January 21, 2026, Hualan Vaccine announced that it recently received the “Clinical Trial Approval Notice” issued by the National Medical Products Administration (NMPA) for its Recombinant Zoster Vaccine (CHO Cell). Following a review conducted under the Drug Administration Law of the People’s Republic of China, the Vaccine Administration Law of the People’s Republic of China, and other relevant regulations, the vaccine (accepted on October 30, 2025) has met the requirements for drug registration. Clinical trials for the prevention of herpes zoster (shingles) are now authorized to proceed. The announcement explains that Herpes Zoster (Shingles) is an acute cutaneous and neurological disease caused by the reactivation of the varicella-zoster virus (VZV) after years of dormancy. It primarily affects adults and the elderly with declining immune function. Characterized by clusters of vesicles along nerves and significant pain, it can severely impact quality of life. Its primary complication, postherpetic ...
- Source: drugdu
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- January 22, 2026
HeartCare Medical (06609.HK) Announces NMPA Acceptance of Registration Application for Self-Expanding Intracranial Drug-Eluting Stent

On January 20, 2026, HeartCare Medical-B (06609.HK) issued an announcement stating that the registration application for its self-developed self-expanding intracranial drug-eluting stent has been formally accepted by the National Medical Products Administration (NMPA) of the People’s Republic of China. Designed for the treatment of intracranial atherosclerotic stenosis, the stent is capable of supporting and reopening narrowed or obstructed lumens while effectively preventing in-stent restenosis. The company stated that there are currently no similar products approved for marketing worldwide, and its research and development progress remains at a leading level within the industry. However, the announcement also noted that there is no guarantee the stent will ultimately be successfully commercialized. Shareholders and potential investors are advised to exercise caution when dealing in the company’s shares. https://finance.eastmoney.com/a/202601213625547124.html
- Source: drugdu
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- January 22, 2026
Two drugs from Hengrui Medicine have received clinical trial approval

On January 21, Hengrui Medicine issued an announcement stating that its subsidiaries, Shanghai Hengrui Medicine Co., Ltd. and Shanghai Shengdi Medicine Co., Ltd., received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration for SHR-7787 Injection and Adebelimab Injection, and will conduct clinical trials in the near future. According to the announcement, SHR-7787 injection is a Class 1 therapeutic biological product.It works by inducing and activating T cells, enabling them to target and kill tumor cells. Adebelimab injection is a humanized anti-PD-L1 monoclonal antibody independently developed by the company. It can block the PD-1/PD-L1 pathway that leads to tumor immune tolerance by specifically binding to PD-L1 molecules, thereby reactivating the anti-tumor activity of the immune system and achieving the purpose of treating tumors. https://finance.eastmoney.com/a/202601213626206498.html
- Source: drugdu
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- January 22, 2026
Subsidiary’s Drug Production License Changed

On January 21, Buchang Pharma’s wholly-owned subsidiary, Shandong Danhong Pharmaceutical Co., Ltd., has obtained a renewed Drug Production License from the Shandong Provincial Drug Administration, which has approved the application for changes to the license. The issuing authority is the Shandong Provincial Drug Administration. Details of the changes: Contract manufacturing has been approved, with Yangling Buchang Pharmaceutical Co. , Ltd. and Shandong Buchang Pharmaceutical Co., Ltd. as the contract manufacturers. The products to be manufactured are loxoprofen sodium oral solution (10ml: 60mg) and melogabalin besylate tablets (2.5mg (C12H19NO2) – 5mg (C12H19NO2)). The contract manufacturing validity period is until July 16, 2028, and is limited to product registration applications. Approval information has also been added, involving ibuprofen sustained-release capsules (National Drug Approval Number H20255656). This change will help the company optimize its production structure, maintain stable production capacity, meet market demand, and have a positive impact on the company’s future operations. ...
- Source: drugdu
- 64
- January 22, 2026
Sunshine Novo’s Small Nucleic Acid Drug IND Application Accepted; Innovative Drug Pipeline Enters Harvest Phase

SSE News / China Securities Online (Reporter: Li Yanzheng) — Sunshine Novo announced on January 21, 2026, that its investigational small nucleic acid drug, ABA001, has formally received Clinical Trial Application (IND) acceptance from the National Medical Products Administration (NMPA). The drug is targeting hypertension, marking a pivotal step forward for the company’s nucleic acid drug platform. ABA001 utilizes GalNAc covalent conjugation technology to precisely deliver siRNA into hepatocytes, specifically degrading AGT mRNA to effectively “shut off” the pressor switch of the Renin-Angiotensin-Aldosterone System (RAAS). Non-clinical data demonstrate that a single subcutaneous injection can produce rapid and sustained blood-pressure-lowering effects in animal models, accompanied by a favorable safety profile. Classified as a Category 1 innovative chemical drug, ABA001 is intended for the treatment of primary hypertension. It offers the potential for quarterly or even semi-annual dosing, a significant improvement over existing daily medications. According to the regulatory review process, if ...
- Source: drugdu
- 74
- January 22, 2026
Big news! Chia Tai Tianqing’s oral GLP-1 has been approved for clinical trials! Can its differentiated “biased” mechanism break through the red ocean market?

On January 20, the CDE (Center for Drug Evaluation) announced the implicit approval for clinical trials, showing that TQF3250 capsules, an oral weight-loss product submitted by Chia Tai Tianqing Pharmaceutical Group in November last year, has been approved for clinical trials. Unlike the more familiar GLP-1 receptor agonists on the market, TQF3250 is an “orally administered small molecule-biased GLP-1 receptor agonist.” It preferentially activates cAMP-related pathways, reducing β-arrestin recruitment and receptor endocytosis, aiming to achieve a better balance between duration of action and tolerability. From a mechanistic research perspective, the signal bias of the GLP-1 receptor is indeed considered a potential direction for optimization by the academic community. Rewinding to a month ago, a landmark event occurred in the global narrative of oral weight-loss drugs. Novo Nordisk’s oral weight-loss drug received FDA approval in December 2025, seizing a crucial position in the oral weight-loss drug market. Subsequently, Eli Lilly’s oral ...
- Source: drugdu
- 62
- January 22, 2026

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