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Clover Biopharmaceuticals RSV Candidate Vaccine Clinical Trial Approved by FDA

Clover Biopharmaceuticals Launches U.S. Trial for RSV Booster Vaccine SCB-1019 By Thomas Yuan CHENGDU — Clover Biopharmaceuticals has received investigational new drug (IND) approval from the U.S. Food and Drug Administration for its RSV vaccine candidate, SCB-1019, the company announced on March 24. The first batch of elderly participants has already been enrolled in a Phase I clinical trial to evaluate the safety and immunogenicity of SCB-1019 as a booster vaccine for respiratory syncytial virus. The trial will recruit up to 160 subjects between the ages of 60 and 85, all of whom had previously received GSK’s AREXVY, the leading approved RSV vaccine, at least two seasons prior. Participants will be randomized to receive either a heterologous booster dose of SCB-1019, a homologous booster of AREXVY, or a placebo. The study aims to assess safety, reactogenicity, and immune response in the context of repeat vaccination. The company’s approach leverages a ...
- Source: drugdu
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- March 25, 2025
CPhI Worldwide

CPhI Worldwide 2025 to Convene in Frankfurt, Spotlighting Global Pharmaceutical Innovation By Thomas Yuan FRANKFURT — The world’s premier pharmaceutical ingredient exhibition, CPhI Worldwide 2025, will be held from October 28 to 30 at the Congress Centre Frankfurt, located at Ludwig-Erhard-Anlage 1, 60327 Frankfurt am Main, Germany. Organized by Informa Markets, the event is expected to draw thousands of global professionals across the biopharmaceutical, medical technology, and health product sectors. Since its launch in 1990, CPhI Worldwide has evolved into the most influential platform for sourcing active pharmaceutical ingredients (APIs), exploring innovative drug formulations, and networking across the international medical supply chain. This year’s edition continues the tradition of excellence, offering a comprehensive showcase of breakthrough technologies and next-generation therapeutics. Diverse Product Categories Covering the Full Pharma Spectrum The exhibition will feature a wide array of products and services, spanning the entire pharmaceutical ecosystem: APIs: Including vitamins, hormones, analgesics, ...
- Source: drugdu
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- March 25, 2025
The clinical trial of the world’s first oncolytic virus product based on the M1 skeleton of the hepatitis A virus, originally created by China, has completed its first administration at Zhongshan Third Hospital

China Launches First Clinical Trial of Intravenous Oncolytic Virus Therapy VRT106 By Thomas Yuan GUANGZHOU — On March 19, 2025, researchers at the Third Affiliated Hospital of Sun Yat-sen University announced a key milestone in the development of VRT106, the world’s first oncolytic virus therapy based on the M1 skeleton of the hepatitis A virus. The Phase I clinical trial has officially begun, with the first patient enrolled and dosed via intravenous injection, showing no adverse reactions or infusion-related events. Jointly led by Professor Peng Liang and Professor Xie Chan from the Department of Infectious Diseases, and Professor Dong Min from Oncology, the trial marks the initial human validation stage for this novel biopharmaceutical designed to treat a range of advanced solid tumors, including liver cancer, colon cancer, triple-negative breast cancer, and cervical cancer. Precision-Targeted Therapy With Dual Anti-Cancer Action Developed by Guangzhou Weilunte Pharmaceutical Technology Co., Ltd. (Weilunte), ...
- Source: drugdu
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- March 24, 2025
Junshi Biotech’s first ADC dual drug has been approved for clinical use, with the potential to be widely effective in treating tumors while overcoming drug resistance

Junshi Biotech Advances Dual-Target ADC Therapy JS212 into Clinical Trials By Thomas Yuan SHANGHAI — Junshi Biotechnology announced yesterday that it has received official approval from China’s National Medical Products Administration to begin clinical trials for JS212, a novel antibody-drug conjugate (ADC) targeting two key cancer receptors: EGFR and HER3. The investigational drug marks the company’s first dual-drug ADC to enter the clinical phase and signals a major milestone in its pipeline of innovative oncology therapies. JS212 is a recombinant humanized bispecific antibody conjugate, designed to treat advanced malignant solid tumors such as lung cancer, breast cancer, and head and neck cancers. These tumor types often exhibit high co-expression of EGFR and HER3, which are known to drive cancer proliferation, migration, and resistance to existing therapies. “JS212 represents an important step forward in our pursuit of precision oncology,” Junshi said in its statement. “Its bispecific targeting could offer broader therapeutic ...
- Source: drugdu
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- March 24, 2025
Innovation breakthrough! 1 Medical Device Approved by FDA

Recently, Moon Surgical announced today that its ScoPilot artificial intelligence platform, developed based on Nvidia technology, has been approved by the US FDA and will be applied to Moon Surgical’s flagship product, the Maestro surgical robot. The first AI system to achieve real-time operation during surgery Moon Surgical was founded in 2019 as a surgical robot startup focused on developing surgical robots for laparoscopic assistance, formerly known as MastOR. It is worth mentioning that the chairman of Moon Surgical’s board of directors is Dr. Frederic Moll, co-founder of Intuitive Medicine and the “father of surgical robots”. The ScoPilot artificial intelligence platform approved this time is the first AI system that can achieve real-time intraoperative operation on a commercial surgical robot platform, aiming to develop and deploy artificial intelligence (AI) based operating room (OR) applications. This platform is built on NVIDIA Holoscan technology and can provide surgeons with the following core ...
- Source: drugdu
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- March 24, 2025
Heavy weight! Two products have been recognized as “Innovative Medical Devices”

According to the China Medical Device Innovation and Priority Approval Database, two products are proposed to be approved as innovative medical devices in Beijing in recent public announcements released by local drug supervision and administration bureaus across the country. They are: the 3D4K fluorescence electronic chest and abdominal cavity endoscope from Seno Micro Medical Technology (Beijing) Co., Ltd. (hereinafter referred to as Seno Micro), and the 3D4K fluorescence endoscope image processor. Multiple innovative achievements have been implemented Founded in 2015, Sinovac has been dedicated to the fields of minimally invasive surgery and minimally invasive interventional therapy for tumors, striving to become the world’s preferred provider of comprehensive minimally invasive surgical solutions. After years of development, Sino Micro has built four major platforms: surgical energy, intelligent anastomosis, surgical vision, and tumor ablation, providing a comprehensive solution for minimally invasive surgical treatment worldwide. At present, Sainuo Micro’s product pipeline mainly includes ultrasonic ...
- Source: drugdu
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- March 24, 2025
Junshi Biopharma’s JS212 for injection clinical trial approved

On the evening of March 20, Junshi Biopharma (688180) announced that the company received the “Notice of Approval for Drug Clinical Trial” approved and issued by the National Medical Products Administration, and the clinical trial application for JS212 for injection was approved. The announcement shows that JS212 is a recombinant humanized anti-epidermal growth factor receptor (hereinafter referred to as “EGFR”) and human epidermal growth factor receptor 3 (hereinafter referred to as “HER3”) bispecific antibody-drug conjugate (hereinafter referred to as “ADC”), which is mainly used for the treatment of advanced malignant solid tumors. Compared with single-target ADC drugs, JS212 can exert tumor suppression by binding to EGFR or HER3, and is expected to be effective for a wider range of tumors, and is expected to overcome drug resistance. Preclinical studies have shown that JS212 has high affinity and specific binding to EGFR and HER3, and has demonstrated significant tumor suppression in ...
- Source: drugdu
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- March 24, 2025
Kangleweishi’s “15-valent HPV vaccine” enters Phase II clinical trial

Kangleweishi Advances World’s Most Comprehensive HPV Vaccine to Phase II Trials By Thomas Yuan BEIJING — Kangleweishi Biotechnology has announced that its 15-valent recombinant human papillomavirus (HPV) vaccine, co-developed with Liaoning Chengda Biotechnology, has officially entered Phase II clinical trials. The update was published on China’s National Drug Administration’s clinical trial registration platform, marking a significant milestone in what may become the most protective HPV vaccine ever developed. The vaccine, produced using Escherichia coli expression systems, has completed Phase I trials without safety concerns and now moves into broader human studies to further evaluate efficacy, immune response, and safety profile. The 15-valent formulation targets all high-risk HPV strains classified by the International Agency for Research on Cancer (IARC), including types 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. If successful, the vaccine could offer more than 96% protection against cervical cancer, as ...
- Source: drugdu
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- March 24, 2025
Chengda Bio’s application for marketing authorization of trivalent influenza vaccine has been accepted

Chengda Bio’s Trivalent Influenza Vaccine Moves Closer to Market with Regulatory Acceptance By Thomas Yuan BENXI — On the evening of March 20, Chengda Biotechnology announced that its trivalent influenza vaccine, developed by its wholly owned subsidiary Chengda Bio (Benxi) Co., Ltd., has received an “Acceptance Notice” from China’s State Food and Drug Administration for domestic production registration and marketing authorization. The approval marks a significant regulatory step in the company’s effort to expand its vaccine portfolio and support national public health measures. Designed to combat seasonal influenza, the split-virus vaccine offers protection against three circulating strains and is expected to play a crucial role in reducing the burden of respiratory infectious diseases, particularly among high-risk populations. A Preventive Solution for a Persistent Threat Influenza remains one of the most widespread and persistent global health threats, often causing annual epidemics that lead to serious complications like pneumonia, bronchitis, and ...
- Source: drugdu
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- March 24, 2025
Tonghua Dongbao Protamine Human Insulin Mixed Injection Obtains Marketing Authorization in Uzbekistan

Tonghua Dongbao Secures Marketing Authorization in Uzbekistan for Human Insulin Injection By Thomas Yuan TONGHUA — Tonghua Dongbao announced on March 20 that it has received marketing authorization from the Ministry of Health of the Republic of Uzbekistan for its Protamine Human Insulin Mixed Injection (30R), marking a strategic advancement in the company’s international expansion across Belt and Road markets. The approved product, a 10ml injectable insulin formulation, combines 30% soluble human insulin with 70% protamine zinc insulin suspension, offering both rapid postprandial glucose control and basal insulin support. It is indicated for the treatment of both type 1 and type 2 diabetes, conditions that continue to see rising global prevalence and impose significant health and economic burdens. The product’s registration number is DV/X 10875/03/25, and Tonghua Dongbao is listed as the marketing authorization holder. Expanding Access to Chronic Disease Therapies Tonghua Dongbao emphasized that the authorization strengthens its ...
- Source: drugdu
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- March 24, 2025

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