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Major ophthalmic new drug successfully completed Phase III trials

On December 1, Belite Bio announced that its core drug Tinlarebant met its primary endpoint in the pivotal Phase 3 DRAGON trial for the treatment of Stargardt disease type 1 (STGD1). The DRAGON trial is a randomized, double-blind, placebo-controlled global study designed to evaluate the safety and efficacy of Tinlarebant in adolescent patients with Stargardt disease. The trial recruited 104 participants from 11 countries and regions, including the United States, the United Kingdom, Germany, France, Belgium, Switzerland, the Netherlands, mainland China, Hong Kong, Taiwan, and Australia. Participants were randomly assigned to the Tinlarebant group and the placebo group in a 2:1 ratio. The results showed that, compared with placebo, Tinlarebant reduced the lesion growth rate by 36%, meeting the study’s primary endpoint. After using the pre-defined analysis method, the results were statistically significant (p=0.0033). Considering the progressive nature of STGD1, further post-hoc analysis provided specific data relevance, showing that the ...
- Source: drugdu
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- December 4, 2025
Simcere Pharmaceutical and Wangshan Wangshui have reached an exclusive licensing agreement for deuterium remidevir hydrobromide for new indications such as RSV infection

On December 3, 2025, Simcere Pharmaceutical Group (2096.HK) and Suzhou Wangshan Wangshui Biopharmaceutical Co., Ltd. (2630.HK) entered into a licensing agreement for deuterium remidevir hydrobromide. Under the agreement, Simcere Pharmaceutical will obtain exclusive licensing rights in Greater China for deuterium remidevir hydrobromide dry suspension for the indications of treating respiratory syncytial virus (RSV) infection and human metapneumovirus (HMPV) infection. This collaboration will further strengthen Simcere Pharmaceutical’s product portfolio in the anti-infective field. Deuterremidevir hydrobromide is an oral nucleoside analogue with broad-spectrum anti-RNA virus potential, exerting its effect by inhibiting viral RNA-dependent RNA polymerase (RdRp). A Phase II clinical trial in China for the treatment of RSV infection in infants (1-24 months) has been completed. Clinical results showed that deuterremidevir hydrobromide dry suspension has good anti-RSV efficacy and safety. Based on the positive results of this clinical trial, deuterremidevir hydrobromide dry suspension received Breakthrough Therapy Designation from the Center for Drug ...
- Source: drugdu
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- December 4, 2025
SAL0140 tablets approved for clinical trials for the treatment of chronic kidney disease

People’s Financial News, December 3, 2025 – Salubris Pharmaceuticals (002294) announced today that the company has received the Clinical Trial Approval Notice issued by the National Medical Products Administration (NMPA), agreeing to conduct clinical trials for its independently developed innovative small molecule drug, SAL0140 tablets, for the treatment of chronic kidney disease (CKD). SAL0140 is an aldosterone synthase inhibitor with independent intellectual property rights belonging to the company. The planned indications for development include uncontrolled hypertension (including resistant hypertension), primary aldosteronism, and chronic kidney disease (CKD), among others. https://finance.eastmoney.com/a/202512033581668270.html
- Source: drugdu
- 81
- December 4, 2025
Self-developed innovative drug FXS0887 approved for clinical trials in advanced malignant solid tumors

Zhongzheng Smart Finance News, Fosun Pharma (600196) announced in the evening on December 3, 2025, that its controlling subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. (hereinafter referred to as “Fosun Pharma Industrial”), has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for its self-developed oral small molecule innovative drug, FXS0887 tablets, for the treatment of advanced malignant solid tumors. Fosun Pharma Industrial plans to initiate Phase I clinical trials in China when conditions are met. According to the announcement, FXS0887 can specifically inhibit the activity of the ATR (Ataxia Telangiectasia and Rad3-related) kinase, thereby inhibiting the malignant proliferation of tumor cells by interfering with cell cycle regulation and DNA damage repair-related pathways. Current preclinical studies have shown that the drug exhibits good antitumor activity in a variety of tumor models, with small off-target risk and good safety. The announcement stated that as of October ...
- Source: drugdu
- 71
- December 4, 2025
15-valent HPV Vaccine Currently in Phase II Clinical Trial Stage

Securities Daily Online – On December 2, Chengda Biotech responded to investor inquiries on the interactive platform, stating that the company’s under-construction Biotech Product R&D and Production Base Project is planned in two phases: Phase I includes facilities such as a production workshop for the 15-valent HPV vaccine, while Phase II consists of standardized biopharmaceutical factory buildings, which will effectively support the industrialization of ongoing R&D projects. Currently, the 15-valent HPV vaccine is in the Phase II clinical trial stage. The vaccine’s R&D, approval process, and project construction are influenced by multiple factors and carry certain uncertainties. The company will promptly disclose any latest developments in accordance with relevant regulations. Reference：https://chat.deepseek.com/a/chat/s/0e718e8d-8f9c-4483-a333-6db4b824d280
- Source: drugdu
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- December 4, 2025
Kangtai Biological’s wholly-owned subsidiary Minhai Biological successfully co-organized the Vaccine Innovation Forum

China Securities Journal, China Securities Network (Wang Luo) — Recently, the award ceremony for the “19th Pharmaceutical Development Award” was held in Beijing. Liu Jiankai, Director and Vice President of Kangtai Biological, and Executive Deputy General Manager of Beijing Minhai Biotechnology Co., Ltd. (hereinafter referred to as “Minhai Biological”), received the “Outstanding Achievement Award.” It is understood that the Pharmaceutical Development Award is a medical science prize established in 1994, primarily recognizing outstanding scientific and technological talents who have achieved breakthrough innovative results in the field of medicine and health. Following the award ceremony, multiple academic exchange sessions were held. Among them, the Vaccine Innovation Forum, themed “Focusing on Frontiers, Interdisciplinary Integration, and Translational Application,” was co-organized by Minhai Biological, a wholly-owned subsidiary of Kangtai Biological. The academic event brought together experts including academicians of the Chinese Academy of Engineering, renowned scholars from universities, experts in the medical field, and ...
- Source: drugdu
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- December 4, 2025
FCE Pharma

Organiser：NürnbergMesse GmbH Time： June 1 -3, 2026 Address：Centro de Exposições Imigrantes Rodovia dos Imigrantes, Km 1,5 São Paulo – SP Exhibition hall：São Paulo Expo Product range: Active Pharmaceutical Ingredients (APIs): Vitamins, hormones, antipyretic and analgesic drugs, digestive system drugs, anti-infective drugs, anti-parasitic drugs, cardiovascular system drugs, intermediates Medical Devices: Pharmaceutical packaging materials, PVC/PVDC composite sheets, rigid PVC sheets, PS sheet materials, packaging anti-counterfeiting technology information, labeling and sleeving technologies, label filling machines, packaging container forming, filling, and sealing machines, wrapping machines, paper-film packaging machinery, etc. Others: Large-volume infusion equipment production lines, dryers, water treatment equipment, refrigeration compressors, distillation equipment, sterilization equipment, tablet presses, coating machines, plastic devices, crystallization equipment, etc. About FCE Pharma： The Brazil São Paulo Pharmaceutical Raw Materials and Pharmaceutical Manufacturing Exhibition (FCE Pharma) is the premier pharmaceutical technology exhibition in South America. It plays a significant role in the development of the pharmaceutical industry not ...
- Source: drugdu
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- December 4, 2025
A Comparative Overview of the US, EU, China, India and Brazil

Against the backdrop of rapid internationalization of pharmaceutical formulations, pharmaceutical excipients – as critical components supporting drug quality and stability – are receiving increasing attention in regulatory frameworks worldwide. For excipient manufacturers planning to expand into overseas markets, understanding the compliance thresholds and regulatory focus of major markets is a necessary prerequisite for designing a global export strategy. Drawing on practical registration experience and international regulatory practices, we compare excipient regulations across five key markets – the United States, the European Union, China, India and Brazil – to help companies build a global compliance framework for excipients. At a Glance: Regulatory Requirements Across Five Major Markets Regional Regulatory Focus – Detailed Analysis United States: Well-established DMF system with emphasis on data transparency The FDA reviews excipients in the context of finished drug product applications. Manufacturers may choose to submit a Type IV DMF (Drug Master File for excipients). Although it ...
- Source: drugdu
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- December 3, 2025
Yuzhiyou Biotechnology Publishes Results of Phase II Clinical Trial of M701 in China

On December 2, YOZY Bio (02496) issued an announcement stating that the results of its independently developed bispecific antibody drug M701 in the Phase II clinical trial in China have been published in the internationally renowned medical journal Experimental Hematology & Oncology. This study included 84 patients, of whom 43 received intraperitoneal infusion of M701. The median puncture-free survival was 75 days in the M701 group and 25 days in the control group, a significant difference (p=0.0065). The 6-month survival rate was 33.3% in the M701 group and 12.1% in the control group. No other serious adverse events were observed in the M701 group. M701 is a bispecific antibody that targets the tumor cell target EpCAM and the immune T cell activation target CD3, aiming to eliminate tumor cells in the peritoneal cavity by activating T cells. Currently, M701 is undergoing multiple clinical trials at different stages for malignant ascites ...
- Source: drugdu
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- December 3, 2025
YueKang KeXiang YKYY018 nebulizer has obtained clinical approval from both China and the United States

It has been learned that recently, the company’s subsidiary, Beijing Yuekang Kechuang Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Yuekang Kechuang”), received a letter from the U.S. Food and Drug Administration approving the clinical trial of YKYY018 nebulizer for the prevention and treatment of respiratory syncytial virus (RSV) infection, and two Drug Clinical Trial Approval Notices issued by the National Medical Products Administration approving the use of YKYY018 nebulizer for post-exposure prophylaxis after contact with patients with respiratory syncytial virus and for the treatment of RSV infection. The company will conduct Phase I clinical trials of this product. Respiratory syncytial virus (RSV) is a ubiquitous and infectious enveloped RNA virus that causes respiratory illnesses, particularly affecting vulnerable groups such as children, the elderly, and those with compromised immune systems. Currently, there are no approved treatments for RSV infection worldwide, indicating a significant and urgent unmet clinical need. YKYY018 nebulized ...
- Source: drugdu
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- December 3, 2025

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