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A new ADC champion has emerged.

ADC drugs have taken a key step toward becoming a first-line treatment for breast cancer. 01 First breakthrough On December 15, the FDA announced approval for the combination of Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate jointly developed by AstraZeneca and Daiichi Sankyo, and Roche’s Perjeta (pertuzumab) for first-line treatment of patients with HER2-positive advanced or metastatic breast cancer . The indication is for adult patients who are confirmed HER2-positive by an FDA-approved testing method and have not previously received chemotherapy for metastatic breast cancer. This approval marks the first time that an ADC drug has been approved by the FDA for first-line treatment of breast cancer, a major solid tumor. This approval is based on a randomized, controlled clinical trial that enrolled 1,157 patients with HER2-positive metastatic breast cancer. The study compared the efficacy of Enhertu in combination with Roche’s HER2-targeted monoclonal antibody Perjeta (pertuzumab) as first-line treatment with the ...
- Source: drugdu
- 38
- December 18, 2025
Domestic ophthalmic monoclonal antibody achieves blockbuster BD

Recently, Changchun High & New Technology Industries Group Co., Ltd. issued an announcement stating that its subsidiary, Saizeng Medical, signed an exclusive licensing agreement with Yarrow Bioscience, Inc. for the GenSci098 injection project. Under the agreement, Saizeng Medical expects to receive an upfront payment of US$120 million and near-term development milestone payments (including a non-refundable and non-deductible upfront payment of US$70 million and subsequent near-term development milestone payments of US$50 million), and will be entitled to receive up to US$1.365 billion in milestone payments, as well as sales royalties of more than 10% of net sales after subsequent product launches. Yarrow will acquire the exclusive global rights to develop, manufacture, and commercialize GenSci098 injection outside of Greater China, for the research, development, and commercialization of GenSci098 injection for indications including thyroid-associated ophthalmopathy (TED) and diffuse toxic goiter (GD). Saizeng Medical will retain the rights to develop and commercialize GenSci098 injection ...
- Source: drugdu
- 35
- December 18, 2025
Clinical trial application for nasal spray accepted, targeting allergic rhinitis.

On December 17, Changfeng Pharmaceutical (02652) announced that its clinical trial application for the self-developed fixed-dose compound preparation olopatadine mometasone nasal spray has been accepted by the National Medical Products Administration (NMPA) of China. The application, numbered CYHL2500215/CYHL2500214, is for the treatment of moderate to severe allergic rhinitis symptoms in adults and adolescents aged 12 years and older. The acceptance of this clinical trial application signifies that the product has officially entered the NMPA’s regulatory review stage for potential clinical development. This product combines antihistamines and corticosteroids, aiming to provide a convenient treatment option for patients whose symptoms are not effectively controlled. The company believes that if the product is successfully developed and approved, it will enhance its allergy and rhinitis product line and may complement its existing product portfolio. The company will continue to communicate with the NMPA, comply with relevant laws and regulations, and advance subsequent clinical development ...
- Source: drugdu
- 31
- December 18, 2025
New drug JSKN027 accepted for clinical trials

On December 17th, CorningJereh Pharmaceutical (09966) announced that its Investigational New Drug (IND) application for its independently developed programmed death-ligand 1 (PD-L1)/vascular endothelial growth factor receptor 2 (VEGFR2) bispecific antibody-drug conjugate (ADC) JSKN027 has been formally accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). 　　The company plans to conduct a Phase I clinical study of JSKN027 for the treatment of advanced malignant solid tumors, aiming to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity in this patient population, and to determine the maximum tolerated dose and/or recommended Phase II dose. 　　JSKN027 is the world’s first PD-L1/VEGFR2 bispecific antibody ADC to enter clinical trials. Preclinical data show that JSKN027 exhibits significant tumor-suppressive activity in both in vitro and in vivo models, and GLP toxicology studies demonstrate good tolerability at the highest dose. Based on its multiple mechanisms of ...
- Source: drugdu
- 32
- December 18, 2025
WHO Warns Europe’s Influenza Peak May Arrive by Year-End

The World Health Organization (WHO) stated on the 17th that influenza is spreading across Europe approximately four weeks earlier than in previous years. Among the 38 countries reporting data, at least 27 have reached high or very high levels of influenza activity. In countries such as Ireland, Montenegro, Serbia, Slovenia, and the United Kingdom, more than half of the influenza-like illness samples tested have been confirmed as influenza virus infections. Dr. Hans Kluge, WHO Regional Director for Europe, noted that the influenza A(H3N2) subtype has become the predominant circulating strain, accounting for about 90% of confirmed cases, but there is no evidence of increased pathogenicity. Early data from the United Kingdom show that the current seasonal influenza vaccine effectively reduces the risk of severe illness caused by this strain. The WHO emphasized that older adults, individuals with underlying health conditions, pregnant women, children, and healthcare workers should be prioritized for ...
- Source: drugdu
- 32
- December 18, 2025
Clinical Trial Application for Modified Vaccinia Ankara (MVA) Monkeypox Attenuated Live Vaccine Accepted for Review

Shanghai Securities News, China Securities Network – Zhifei Biological announced on the evening of December 17 that its wholly-owned subsidiary, Anhui Zhifei Longcom Biopharmaceutical Co., Ltd., recently received the “Drug Clinical Trial Application Acceptance Notice” (Acceptance No.: CXSL2501083) from the National Medical Products Administration (NMPA) for its “Modified Vaccinia Ankara (MVA) Monkeypox Attenuated Live Vaccine.” If no negative feedback or queries are received from the Center for Drug Evaluation within 60 days from the acceptance date, clinical trials may proceed according to the submitted plan. Background information indicates that monkeypox is a zoonotic disease caused by the monkeypox virus. Its clinical course typically consists of two phases: the invasive phase and the rash phase. The invasive phase lasts 0–5 days and is characterized by fever, intense headache, lymphadenopathy, back pain, myalgia, and profound asthenia. Lymphadenopathy is a distinctive feature of monkeypox. The virus primarily spreads through close skin contact (particularly ...
- Source: drugdu
- 32
- December 18, 2025
Recombinant Hepatitis B Vaccine Approved for Clinical Trials to Prevent HBsAg Rebound in Clinically Cured Chronic Hepatitis B Patients

BioKangtai (300601): Recombinant Hepatitis B Vaccine Approved for Clinical Trials to Prevent HBsAg Rebound in Clinically Cured Chronic Hepatitis B Populations PEOPLE’S FINANCE NEWS, December 17 — Shenzhen Kangtai Biological Products Co., Ltd. (BioKangtai, 300601.SZ) announced on December 17 that its self-developed Recombinant Hepatitis B Vaccine (Saccharomyces cerevisiae) (60μg) has received a “Drug Clinical Trial Approval Notice” from the National Medical Products Administration (NMPA) for a new indicated population. The notice approves clinical trials of this vaccine to prevent HBsAg seroreversion (rebound) in populations who have achieved functional (clinical) cure for chronic hepatitis B. https://finance.eastmoney.com/a/202512173594363010.html
- Source: drugdu
- 28
- December 18, 2025
Grand Pharma’s self-developed small-molecule FAP-targeting RDC drug receives FDA IND clearance in the U.S.

Grand Pharma’s Self-Developed Global Innovative FAP-Targeting RDC Drug GPN01530 Receives FDA IND Approval for U.S. Clinical Trials SHANGHAI SECURITIES NEWS, China Securities Net (Reporter: Zhang Xue) — Grand Pharmaceutical Group Limited (“Grand Pharma”) announced on December 17 that its self-developed, global innovative Radionuclide Drug Conjugate (RDC) targeting Fibroblast Activation Protein (FAP), GPN01530, has recently received official approval from the U.S. FDA to commence Phase I/II clinical trials for the diagnosis of solid tumors. GPN01530 is Grand Pharma’s first self-developed RDC product to be approved by the FDA for clinical research. The company stated that this approval marks a significant milestone in its “Go Global” strategy and provides a vital template for the international development of its radiopharmaceutical pipeline. FAP (Fibroblast Activation Protein) is a key marker of cancer-associated fibroblasts (CAFs). It promotes tumor growth and invasion by participating in extracellular matrix remodeling, tumor cell proliferation regulation, and immunosuppression. It has ...
- Source: drugdu
- 28
- December 18, 2025
Pharmagora Plus 2026

Organiser：CloserStill Media Ltd Time： March 14 – 15, 2026 Address：1, place de la Porte de Versailles 75015 Paris, France Exhibition hall：Paris Expo Porte de Versailles Product range: Orthopedic surgery, laboratories, shops, banks, insurance companies and IT firms, conditions related to LES (Lower Esophageal Sphincter, assuming a specific medical context; if not, please clarify), e-health, the future of pharmacies, pharmaceuticals, scientific instruments, research and development, herbal and traditional Chinese medicine industries About Pharmagora Plus 2026： The Pharmagora Plus in Paris, France, is the largest and most significant pharmaceutical exhibition within the same industry in France. Organized by the well-known French exhibition company CloserStill Media Ltd, since its inception, the exhibition has been growing in scale and influence, providing an outstanding display platform for more countries and enterprises.
- Source: drugdu
- 29
- December 18, 2025
Subsidiary Signs Exclusive Licensing Agreement for GenSci098 Injection Project

According to the announcement, the company’s subsidiary, Shanghai Saizeng Medical Technology Co., Ltd. (hereinafter referred to as “Saizeng Medical”), recently signed an exclusive licensing agreement with Yarrow Bioscience, Inc. for the GenSci098 injection project. Under the agreement, Saizeng Medical expects to receive an upfront payment of US$120 million and near-term development milestone payments (including a non-refundable and non-deductible upfront payment of US$70 million and subsequent near-term development milestone payments of US$50 million), and will be eligible for milestone payments related to specific research, regulatory, and commercialization. Saizeng Medical will be entitled to receive up to US$1.365 billion in milestone payments for this exclusive license, and will also be entitled to royalties exceeding 10% of net sales after the product’s launch. https://finance.eastmoney.com/a/202512153591987252.html
- Source: drugdu
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- December 17, 2025

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