media – Page 23 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Gravel Biotech’s next-generation gene knockout TIL product GT307 injection receives FDA IND approval in the United States

On December 23, 2025, GT307 injection , a next-generation gene-knockout tumor-infiltrating lymphocyte (TIL) product independently developed by Sapphire Biotech , received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) . This marks another significant milestone for Sapphire Biotech in the field of high-safety gene-edited TILs, following the completion of clinical trial applications for its GT201 product in China and the United States. It also signifies that multiple cell therapy pipelines of the company have entered the clinical stage in the United States. GT307 is a next-generation dual-gene knockout TIL product based on CRISPR gene editing technology, designed to address key bottlenecks in traditional TILs, such as functional exhaustion and insufficient persistence in the tumor microenvironment. Leveraging the ImmuT Finder® high-throughput immunomodulatory target screening platform independently developed by SandGrey Biotech, the company systematically discovered and identified key immunomodulatory factors that inhibit the anti-tumor function of TILs, ...
- Source: drugdu
- 87
- December 26, 2025
Enhertu received approval for its fifth indication in the country; the FDA approved the world’s first MASP-2 antibody

Enhertu has been approved in the country one after another. On December 25, Daiichi Sankyo announced that its blockbuster HER2 ADC drug, trastuzumab (Enhertu®), co-developed with AstraZeneca, has been approved for marketing in China for a new indication: adult patients with HR-positive, HER2-low expression (IHC 1+ or IHC 2+/ISH-) or HER2-ultra-low expression (IHC 0, with membrane staining) breast cancer. New developments in FDA approvals. On December 24, the FDA approved Narsoplimab from Omeros, the first MASP-2 antibody, for the treatment of thrombotic microangiopathy associated with hematopoietic stem cell transplantation (TA-TMA). What other hot topics in the domestic and international pharmaceutical markets were worth noting in the past day? Let Amino Jun take you to find out. / 01 / Market Express 1) Enhua Pharmaceutical and Luye Pharma reach an agreement for the domestic commercialization of three psychiatric drugs. On December 24, Enhua Pharmaceutical announced a strategic cooperation agreement with Luye ...
- Source: drugdu
- 77
- December 26, 2025
Reinforcing Efficacy Both as Monotherapy and in Combination with Abemaciclib in Patients with ER+, HER2- Advanced Breast Cancer

December 12, 2025 — Eli Lilly and Company announced updated results from the Phase 3 EMBER-3 clinical trial of the oral estrogen receptor antagonist imlunestrant. The study enrolled patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–) advanced or metastatic breast cancer (MBC) who had experienced disease progression after prior treatment with an aromatase inhibitor (AI) with or without a CDK4/6 inhibitor. Compared to endocrine therapy, imlunestrant monotherapy demonstrated a clinically meaningful 38% reduction in the risk of disease progression or death in patients with an ESR1 mutation (median progression-free survival (PFS): 5.5 months vs. 3.8 months; HR = 0.62; 95% CI: 0.47–0.82; nominal p = 0.0007). It also extended median overall survival (OS) by 11.4 months (34.5 months vs. 23.1 months; HR = 0.60; 95% CI: 0.43–0.86; p = 0.0043, did not meet the prespecified threshold for statistical significance). Among all patients, imlunestrant in combination with ...
- Source: drugdu
- 72
- December 26, 2025
HIV Antibody Oral Mucosal Transudate Self-Testing Kit Obtains Medical Device Registration Certificate

People’s Finance News, December 25 – Wantai Biotech (603392) announced on December 25 that its self-developed HIV (Type 1+2) Antibody Oral Mucosal Transudate Testing Kit (Colloidal Gold Method) has obtained the “Medical Device Registration Certificate (In Vitro Diagnostic Reagent)” issued by the National Medical Products Administration (NMPA). Additionally, the clinical trial application for the “Recombinant Trivalent Rotavirus Subunit Vaccine (Escherichia coli)”, submitted by its wholly-owned subsidiary Xiamen Wantai Kangtai Biotech Co., Ltd., has been accepted for review by the NMPA. Reference：https://finance.eastmoney.com/a/202512253601917149.html
- Source: drugdu
- 71
- December 26, 2025
Wantai Biotech’s Clinical Trial Application for Recombinant Trivalent Rotavirus Subunit Vaccine Accepted for Review

Beijing Business Today – On December 25, Wantai Biotech announced that its wholly-owned subsidiary, Xiamen Wantai Kangtai Biotech Co., Ltd., received the “Acceptance Notice”, an administrative licensing document issued by the National Medical Products Administration (NMPA). The clinical trial application for the company’s “Recombinant Trivalent Rotavirus Subunit Vaccine (Escherichia coli)” has been accepted for review. According to the announcement, this product is a recombinant protein vaccine produced using genetic engineering recombination technology and an Escherichia coli expression system. Its main active component is a truncated rotavirus spike protein VP4. Reference：https://finance.eastmoney.com/a/202512253601968277.html
- Source: drugdu
- 75
- December 26, 2025
Receiving Drug Registration Certificate

Securities Daily News On December 25, Baiyunshan announced that its consolidated entity, Guangzhou Baiyunshan Biological Products Co., Ltd., has received the Drug Registration Certificate for the Freeze-dried Human Rabies Vaccine (Vero Cells) approved and issued by the National Medical Products Administration. reference：https://finance.eastmoney.com/a/202512253602097376.html
- Source: drugdu
- 63
- December 26, 2025
【EXPERT Q&A】What are the considerations to keep in mind when applying for EU CE certification?

Drugdu.com expert’s response: When applying for the EU CE certification, the following considerations should be taken into account to ensure a smooth process and compliance with regulatory requirements: I. Clarify the Scope of Certification and Applicability of Directives Confirm Whether the Product Requires CE Certification: Not all products require CE certification. Only those products that fall within the scope of the EU “CE Directives” or “Regulations” must undergo certification and affix the CE mark. Currently, the EU has issued more than 20 CE-related directives, covering common categories such as electronics and electrical appliances, machinery, medical devices, toys, and building materials. Determine Applicable Directives and Standards: Match the corresponding EU directives (such as the Low Voltage Directive, Electromagnetic Compatibility Directive, Medical Device Regulation, etc.) based on the product type, and verify the latest harmonized standards (such as EN 60335-1 for household appliance safety standards). Avoid invalid certification due to incorrect directive ...
- Source: drugdu
- 82
- December 26, 2025
CoreMedik Unlocks Dual Certifications for Implantation & Intervention of Artificial Heart

Breaking news has just emerged from the artificial heart sector. According to the official website of the National Medical Products Administration (NMPA), CoreMedik’s Interventional Left Ventricular Assist Device and Interventional Left Ventricular Assist Catheter Pump Kit have obtained approval for marketing. This is not only China’s first domestically-developed interventional artificial heart product to secure marketing approval, but also makes CoreMedik the world’s sole enterprise holding regulatory approvals for both implantable and interventional artificial hearts simultaneously. It marks that China’s domestic artificial heart technology has officially joined the world’s leading ranks, bringing a lifeline to a vast number of high-risk cardiovascular disease patients. The NMPA commented: “This system adopts miniaturized axial motor technology for short-term left ventricular support. As an innovative domestic technology, it fills the gap in interventional cardiac assist device technology in China.” Homegrown “Life Pumps” End Overseas Technological Hegemony Homegrown “Life Pumps” End Overseas Technological HegemonyThe approval of ...
- Source: drugdu
- 72
- December 25, 2025
First in over 70 years! New drug for schizophrenia approved in China

On December 23, Zai Lab announced that the NMPA (National Medical Products Administration) has approved its New Drug Application (NDA) for xenometrine trastuzumab capsules for the treatment of schizophrenia in adults . The press release stated that this is the first approved schizophrenia therapy with a novel mechanism of action in over 70 years, representing a fundamental breakthrough in the treatment of schizophrenia.KarXT is an oral combination of an M1/M4 type muscarinic acetylcholine receptor agonist and a muscarinic receptor antagonist. Unlike traditional dopamine-targeting antipsychotics, KarXT affects core disease pathways by selectively acting on muscarinic acetylcholinesteric M1 and M4 receptors in the brain.In November 2021, Zai Lab acquired the development and commercialization rights for KarXT in Greater China (including mainland China, Hong Kong, Macau, and Taiwan) from Karuna Therapeutics for $187 million . In December 2023, BMS acquired Karuna for $14 billion , adding the product to its pipeline.In September 2024, ...
- Source: drugdu
- 73
- December 25, 2025
Is the “anti-aging drug” a scientific breakthrough or a capital game?

On December 23, 2025 , the official WeChat account of Kingdaw Group announced that the β – nicotinamide mononucleotide ( NMN ) raw material produced by its wholly-owned subsidiary, Inner Mongolia Kingdaw Pharmaceutical Co., Ltd., had successfully completed the relevant compliance procedures of the U.S. Food and Drug Administration ( FDA ) regarding New Dietary Ingredient ( NDI ) and obtained an Acknowledgement Letter from the FDA . Completing the above procedures enables Kingdaw’s products to be legally marketed in the United States, and also provides a more solid foundation for Doctor ‘s Best, the company’s US subsidiary , to resume and advance its NMN dietary supplement product portfolio. It’s worth noting that Kingway is not the only company to receive FDA approval. According to information from the domestic synthetic biology company Shangke Biotechnology, on December 2, 2025 , the FDA officially notified Shangke Biotechnology to reinstate its NMN raw ...
- Source: drugdu
- 82
- December 25, 2025

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.