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Clinical trial application for DR30206 for injection approved

Huadong Medicine, according to the announcement, the holding subsidiary, Zhejiang Daer Biotechnology Co., Ltd., recently received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration (NMPA). The clinical trial application for DR30206 for injection submitted by Daer Biotechnology has been approved. The indication is: This product is intended as consolidation therapy for patients with locally advanced/unresectable (stage III) non-small cell lung cancer who have not progressed after concurrent/sequential chemoradiotherapy. Source: https://finance.eastmoney.com/a/202610163898618389.html
- Source: drugdu
- 102
- October 19, 2026
Warrant Pharmaceuticals’ active pharmaceutical ingredients, terbutaline sulfate and indocyanine green, have been approved for marketing

Recently, Warrant Pharmaceuticals(688799) Its wholly-owned subsidiary, Hunan Huana Pharmaceutical Chiral Drug Co., Ltd., successively received the ” Chemical Raw Material ” certificates for terbutaline sulfate and indocyanine green issued by the National Medical Products Administration.The drug marketing application approval notice, along with the formulation, received an “A” rating in the joint review and approval process, indicating that it meets the relevant national drug review technical standards and has been approved for use in domestic formulations. According to reports, terbutaline sulfate is the raw material for preparations such as terbutaline sulfate nebulized inhalation solution.Terbutaline sulfate nebulized inhalation solution is mainly used to relieve bronchospasm associated with bronchial asthma, chronic bronchitis, emphysema, and other lung diseases. Indocyanine green is the active pharmaceutical ingredient (API) for products such as injectable indocyanine green . Injectable indocyanine green, often referred to as “GPS on a knife’s edge,” is primarily used to diagnose various liver diseases, ...
- Source: drugdu
- 95
- October 19, 2026
【EXPERT Q&A】What is the process for applying for a medical device registration certificate?

Drugdu.com expert’s response: When applying for a Medical Device Registration Certificate, you should not start by simply asking “what documents to prepare”. The more accurate workflow is to first determine the classification of the medical device, confirm the competent regulatory authority for acceptance, and finally prepare the testing, clinical evaluation, quality system and registration application documents. In China, Class I medical devices are subject to filing management, while Class II and Class III medical devices are subject to registration management. That is to say, the “Medical Device Registration Certificate” in the general sense mainly corresponds to Class II and Class III medical devices. Domestic Class III medical devices, as well as imported Class II and Class III medical devices, are reviewed and approved by the National Medical Products Administration (NMPA); domestic Class II medical devices are generally the responsibility of the provincial drug regulatory authorities. Before initiating the process, the ...
- Source: drugdu
- 105
- October 19, 2026
Vir Biotechnology Enters Multi-Program Collaboration with Gilead Sciences to Develop Novel PRO-XTEN® Dual-masked T-cell Engagers for Solid Tumors

On October 14, 2026, Vir Biotechnology, Inc. (Nasdaq: VIR) announced a collaboration and license agreement with Gilead to discover and engineer three novel PRO-XTEN® dual-masked T-cell engager (TCE) development candidates targeting selected solid tumor-associated antigens. Gilead will have an exclusive license to develop and commercialize the novel TCEs. The collaboration combines Vir Biotechnology’s T-cell engager discovery, AI-enabled protein engineering and clinically-validated PRO-XTEN® masking technology with Gilead’s oncology development and commercialization expertise. This is the Company’s second collaboration building on the universal PRO-XTEN® masking technology. Through this collaboration, Vir Biotechnology will apply its deep expertise in TCE discovery and protein engineering, its proprietary dAIsY™ (data AI structure and antibodY) platform for rapid, multiparameter optimization of high-quality TCEs and the universal PRO-XTEN® masking technology to develop next-generation TCEs, each with potent anti-tumor activity and a wide therapeutic index across solid tumor targets addressing areas of high unmet need. “We believe TCEs have ...
- Source: drugdu
- 134
- October 16, 2026
Subsidiary’s YKYY036 Injection Receives Clinical Trial Approval from NMPA and FDA

People’s Finance News, October 13th – Yuekang PharmaceuticalOn October 13, (688658) announced that its subsidiaries, Beijing Yuekang Kechuang Pharmaceutical Technology Co., Ltd. and Hangzhou Tianlong Pharmaceutical Co., Ltd. of Yuekang Pharmaceutical Group, recently received approval notices from the National Medical Products Administration (NMPA) for the use of YKYY036 injection for obese or overweight patients. Simultaneously, Beijing Yuekang Kechuang Pharmaceutical Technology Co., Ltd. recently received a letter from the U.S. Food and Drug Administration (FDA) approving its application for clinical trials of YKYY036 injection for overweight or obese patients. Source: https://finance.eastmoney.com/a/202610133894283434.html
- Source: drugdu
- 107
- October 16, 2026
BioNTech’s mRNA Cancer Vaccine BNT113 Falls Short of Primary Endpoint in Phase 3 Trial

On October 13, BioNTech announced the first top-line results of its AHEAD-MERIT Phase 2/3 clinical trial (NCT04534205) for its mRNA cancer immunotherapy candidate BNT113 . Unfortunately, BNT113 in combination with pembrolizumab as first-line treatment for unresectable recurrent or metastatic HPV16-positive, PD-L1-positive head and neck squamous cell carcinoma failed to meet the first of the dual primary endpoints—progression-free survival —and did not statistically demonstrate a significant improvement over pembrolizumab monotherapy. Following the announcement, BioNTech’s stock price fell by about 6% during trading, casting a shadow over market enthusiasm for the mRNA tumor vaccine sector once again. It is important to note that this setback does not equate to a complete failure of the trial. The independent data monitoring committee recommends that the trial proceed as planned and that the second dual primary endpoint—overall survival—be assessed. According to the pre-specified statistical design of the trial, even if the progression-free survival (PFS) endpoint ...
- Source: drugdu
- 178
- October 16, 2026
Foghorn Therapeutics’ Collaboration Terminated by Eli Lilly; Company to Lay Off 40% of Its Workforce

recently announced that Eli Lilly has terminated its collaboration with the company . The core SMARCA2 selective inhibitor FHD-909 failed to demonstrate the efficacy required to advance to the expansion phase in Phase I dose escalation, and the related SMARCA2 degrader project has also been discontinued. Following the announcement, Foghorn’s stock price plummeted, falling by more than 40% at one point during the day , leaving its market capitalization at only about $130 million. As a result, Foghorn’s board of directors approved a restructuring plan that would reduce its workforce by about 40% , bringing the total number of employees down to about 65, in order to extend its cash runway to the second half of 2029. Why did a four-year collaboration end so suddenly? Why was the cooperation terminated? The key to understanding Eli Lilly’s “return” lies in understanding the decision-making logic of MNCs in the early stages of ...
- Source: drugdu
- 150
- October 16, 2026
Visara (USA) Acquires Overseas Rights to Haite Bio’s HT006.2.2 Eye Drops

On October 13, 2026, Haitai Bio (300683.SZ) announced that it had signed an exclusive cooperation and licensing agreement with Visara, Inc., a US company, regarding the HT006.2.2 eye drop project. According to the agreement, Visara will obtain exclusive rights outside of Greater China to develop, commercialize, manufacture, contract manufacture, use, sell, offer for sale, import, export, and otherwise utilize the licensor and licensed products of HT006.2.2 eye drops. HT006.2.2 eye drops are a recombinant human nerve growth factor (rhNGF) ophthalmic formulation independently developed by the company with independent intellectual property rights, targeting tropomyosin receptor kinase A (TrkA) and p75 neurotrophic factor receptor (p75NTR). Visara will pay the company an upfront payment of US$7 million plus recent milestone payments. Depending on the progress of clinical development and commercialization, Haitai Bio will also be entitled to receive milestone payments related to research, registration, and commercialization up to a maximum of US$104 million. ...
- Source: drugdu
- 151
- October 16, 2026
Asia Pacific Pharmaceutical’s Shengyao Guangyan Obtains a New Acne Drug Technology Achievement from Quzhou Fudan Research Institute

On October 13, 2026, Zhejiang Shengyao Guangyan Pharmaceutical Co., Ltd. (hereinafter referred to as “Shengyao Guangyan”), a wholly-owned subsidiary of Asia Pacific Pharmaceutical (002370.SZ), signed a “Letter of Intent for Cooperation on Innovative Drug Technology Transaction” with Quzhou Fuda Biomedical Innovation Research Institute (hereinafter referred to as “Quzhou Fudan Research Institute”), intending to introduce all the technological achievements of the Class 1.1 small molecule innovative drug “a BODIPY photosensitizer for acne treatment” held by Quzhou Fudan Research Institute . The target project of this collaboration is a Class 1.1 small molecule innovative drug, “A BODIPY-type photosensitizer for acne treatment,” belonging to the cutting-edge field of photodynamic therapy. It is currently in the PCC (preclinical candidate compound) stage, with one Chinese patent application filed. The indication is acne and other applications. The transaction consideration includes a total of RMB 25 million for R&D and approval milestone payments, a total commercialization milestone ...
- Source: drugdu
- 110
- October 16, 2026
Zelgen Submits a Marketing Application in China for Gecacitinib in Ankylosing Spondylitis

On October 14, 2026, Zekjing Biotechnology (688266.SH) announced that it had submitted a third marketing application for gecacitinib to the National Medical Products Administration for the treatment of active ankylosing spondylitis. Gecacitinib is a novel JAK inhibitor independently developed by the company, which owns the intellectual property rights to the product. Previously, the drug had been approved for marketing by the National Medical Products Administration for two indications: the treatment of intermediate- to high-risk myelofibrosis and severe alopecia areata in adults. The myelofibrosis indication has been included in the 2025 National Reimbursement Drug List. Ankylosing spondylitis is an arthritis characterized by long-term inflammation of the spinal joints, typically manifesting as inflammation of the sacroiliac joints and spinal entheses. The Chinese market for ankylosing spondylitis drugs is projected to reach RMB 17 billion by 2025, with a compound annual growth rate of 12.1% from 2020 to 2025. Source: https://mp.weixin.qq.com/s?__biz=MzA5Njc0MTAxOQ==&mid=2650033491&idx=2&sn=0acfe69713aae899421bc4c8d33101c2&chksm=89939f3bf89bb9f002129378fbe4bfc53f860
- Source: drugdu
- 81
- October 16, 2026

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