media – Page 19 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

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
- 75
- 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
- 81
- 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
- 68
- 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
- 60
- 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
- 70
- March 24, 2025
【EXPERT Q&A】How to do registration test and clinical evaluation for IVD reagents with different sampling methods?

Drugdu.com expert’s response: For IVD reagents with different sampling methods, their registration inspection and clinical evaluation need to follow certain procedures and standards to ensure product safety and effectiveness. Below is a detailed breakdown of this process: I. Registration Inspection 1.Selection of Representative Specifications for Inspection: According to the Measures for the Registration of In Vitro Diagnostic Reagents, if a registration application includes different packaging specifications (such as different sampling methods), one representative specification can be selected for inspection. The selected specification should cover the key performance parameters of all sampling methods, such as the limit of detection (LoD) and precision. 2. Performance Verification Items: Key Parameter Verification: This includes accuracy, precision (repeatability/reproducibility), LoD, limit of quantitation (LoQ), linear range, matrix effect, cross-reactivity, etc. Sampling Method Specificity Verification: Testing should be conducted separately for different sampling methods (e.g., manual/automatic, different sampling volumes) to ensure consistency in results. Communication with Inspection Agencies: ...
- Source: drugdu
- 85
- March 24, 2025
Dapeng Pharma acquires an ADC company for $1.14 billion

Dapeng Pharmaceutical Acquires Araris Biotech in $1.14 Billion Deal to Advance Next-Gen ADC Therapies By Thomas Yuan, Health and Biotechnology Correspondent LONDON — International venture capital firm 4BIO Capital announced on March 17, 2025, that its portfolio company Araris Biotech AG has entered into a landmark acquisition agreement with Dapeng Pharmaceutical Co., Ltd. The deal, valued at up to $1.14 billion, includes a $400 million upfront payment, with an additional $740 million tied to short- and long-term clinical and commercial milestones. The acquisition is expected to be finalized in the first half of 2025. The transaction underscores growing global investment in antibody-drug conjugates (ADCs)—a fast-emerging class of targeted biopharmaceuticals that combine precision antibodies with cytotoxic payloads to attack cancer cells with minimal off-target toxicity. A Strategic Bet on ADC Innovation Founded in Switzerland, Araris Biotech specializes in developing next-generation ADC platforms, powered by its proprietary AraLinQ™ technology. The company ...
- Source: drugdu
- 83
- March 21, 2025
Newest! One medical device has been approved for market by the FDA

Monogram Technologies Secures FDA Clearance for Robotic Knee Replacement System By Thomas Yuan, Health and Medical Technology Correspondent AUSTIN, Texas — Monogram Technologies (NASDAQ: MGRM) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its mBôs Total Knee Replacement (TKA) robotic system, marking a major milestone in the company’s push to commercialize next-generation orthopedic surgical solutions. Designed to bring precision, safety, and efficiency to robot-assisted knee replacement surgeries, the mBôs system integrates machine learning, augmented reality, and autonomous cutting technology to deliver a personalized and streamlined surgical experience. The platform also features expansion-ready architecture, with plans to support future applications across the broader field of orthopedic surgery. “This is a pivotal achievement for Monogram,” said CEO Ben Sexson. “FDA clearance validates the technical rigor, innovation, and collaborative drive behind our mBôs system and represents a significant step forward for robotic medical technology in orthopedics.” ...
- Source: drugdu
- 133
- March 21, 2025
Fosun Pharma’s new monoclonal antibody has been granted orphan drug status by the FDA, targeting gastric cancer

Fosun Pharma’s Anti-HER2 Antibody HLX22 Receives FDA Orphan Drug Designation for Gastric Cancer By Thomas Yuan, Health and Biotechnology Correspondent SHANGHAI — On March 19, Fosun Pharma announced that its innovative anti-HER2 monoclonal antibody, HLX22, has been granted orphan drug status by the U.S. Food and Drug Administration for the treatment of gastric cancer, marking a significant milestone in the global development of targeted therapies for aggressive gastrointestinal malignancies. HLX22 is currently undergoing an international Phase 3 multicenter clinical trial (HLX22-GC-301), in combination with trastuzumab and chemotherapy, as a first-line treatment for HER2-positive advanced gastric cancer. The trial has received IND approvals from regulatory agencies in China, the United States, Japan, and Australia, and the first patient has already been dosed globally. Addressing a High-Mortality Cancer with Unmet Needs Gastric cancer is often diagnosed at an advanced stage due to subtle early symptoms, contributing to a dismal 5-year survival ...
- Source: drugdu
- 106
- March 21, 2025
Ruikang Trastuzumab for Injection is selected for the eighth public announcement of breakthrough therapeutic varieties

Hengrui’s Ruikang Trastuzumab Designated Breakthrough Therapy for HER2+ Cervical Cancer By Thomas Yuan, Health and Biotechnology Correspondent SHANGHAI — On the evening of March 19, Suzhou Shengdia Biopharmaceutical Co., Ltd., a subsidiary of Hengrui Medicine, announced that its investigational therapy Ruikang Trastuzumab for Injection (SHR-A1811) has once again been listed as a proposed breakthrough therapeutic variety by China’s Drug Review Center under the National Medical Products Administration — marking its eighth such designation. SHR-A1811 is being developed for patients with recurrent or metastatic cervical cancer expressing HER2 (IHC ≥ 1+) who have progressed after platinum-based chemotherapy and immune checkpoint inhibitor therapy. This population, which faces limited second-line treatment options, represents a critical unmet need in women’s oncology. Addressing an Urgent Clinical Gap Cervical cancer remains a major public health concern in China and worldwide, ranking first among female reproductive system tumors and sixth in cancer-related deaths among Chinese ...
- Source: drugdu
- 100
- March 21, 2025

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