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【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
- 55
- 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
- 59
- 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
- 83
- 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
- 73
- 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
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- March 21, 2025
Zhifei Bio’s 15-valent pneumococcal conjugate vaccine Phase III clinical trial fully achieved the preset goals

On the evening of March 19, the “15-valent pneumococcal conjugate vaccine” developed by Beijing Zhifei Green Bamboo Biopharmaceutical Co., Ltd. obtained the Phase III clinical trial summary report. The report shows that the vaccine “has good immunogenicity and safety, fully achieved the preset goals of the clinical trial, is non-inferior to the control vaccine in terms of immunogenicity, and meets the design requirements of the “Technical Guidelines for Clinical Comparability Studies of Preventive Vaccines” for immunogenicity and safety evaluation.” It is understood that the “15-valent pneumococcal conjugate vaccine” developed by Zhifei Bio has no similar products approved for marketing in China. The vaccine is used to prevent infectious diseases caused by 15 serotypes of pneumococci, covering the 15 serotypes with the highest detection rates in Asia, and is also in line with the distribution of dominant serotypes in China. The company pointed out that according to the relevant national drug ...
- Source: drugdu
- 58
- March 21, 2025
【EXPERT Q&A】What is the evaluation basis of the second type of medical device clinical trial verification?

Drugdu.com expert’s response: The evaluation basis for the clinical trial inspection of Class II medical devices mainly includes the following aspects: I. Regulatory Level Regulations on the Supervision and Administration of Medical Devices: As the basic regulation for the supervision of medical devices, this regulation stipulates the principles and requirements for the management of medical device clinical trials, serving as a crucial basis for clinical trial inspections. Measures for the Registration and Filing of Medical Devices: It clarifies the procedures, requirements, and conditions for the registration and filing of medical devices, providing a basis for the registration-related matters involved in clinical trial inspections. Measures for the Registration and Filing of In Vitro Diagnostic Reagents: This regulation standardizes the registration and filing of in vitro diagnostic reagents and serves as an important basis for the clinical trial inspection of Class II medical devices that are in vitro diagnostic reagents. Quality Management ...
- Source: drugdu
- 48
- March 21, 2025
Chengda Bio and Kangle Guardian 15-valent HPV vaccine will start Phase II clinical trials

On the evening of March 19, Chengda Bio issued an announcement that the recombinant 15-valent human papillomavirus vaccine (Escherichia coli) (hereinafter referred to as “this vaccine” or “15-valent HPV vaccine”) jointly developed by the company and Beijing Kangle Guardian Biotechnology Co., Ltd. (hereinafter referred to as “Kangle Guardian”) has completed Phase I clinical trials and will start Phase II clinical trials. The 15-valent HPV vaccine jointly developed by Chengda Bio and Kangle Guardian is the highest-priced HPV vaccine that has been marketed or approved by IND worldwide so far. This vaccine covers all high-risk HPV types defined by IARC and can increase the protection rate of cervical cancer to more than 96%. This vaccine is used to prevent persistent infection caused by human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68, and diseases such as CIN, VIN, VaIN, AIN, ...
- Source: drugdu
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- March 21, 2025
Xinda launches “new engine”

Recently, Innovent Biologics received good news that its self-developed new ophthalmic drug, Tetuinumab N01 Injection (IBI311), was approved for marketing under the trade name: Symbimin. This is China’s first and the world’s second IGF-1R antibody drug for the treatment of thyroid eye disease (TED). This is also the first blockbuster new drug approved by Innovent Biologics this year. At the same time, the company’s other two highly anticipated potential blockbuster products – Masudopeptide and Piconazole are also expected to be approved for marketing this year, opening up a rapid growth channel in the non-tumor field. China’s first Thyroid eye disease (TED), also known as GRAVES eye disease, is an autoimmune disease closely related to thyroid disease. According to statistics, about 25%-50% of patients with diffuse goiter and hyperthyroidism will have varying degrees of GRAVES eye disease, which ranks first in the incidence of adult orbital diseases. In recent years, the ...
- Source: drugdu
- 44
- March 21, 2025
AIM Vaccine expects revenue of 1.25 billion to 1.3 billion yuan in 2024

AIM Vaccine (06660) issued an announcement that it is expected that the Group’s unaudited revenue will be between 1.25 billion and 1.3 billion yuan during the reporting period ending December 31, 2024, an increase of 60 million to 110 million yuan from 1.19 billion yuan in the previous year, an increase of 5% to 9%. At the same time, the unaudited net loss is expected to be between 250 million and 290 million yuan, a significant reduction from the net loss of 1.95 billion yuan in the previous year, with a reduction of 85% to 87%. The announcement pointed out that the main reason for the increase in revenue was the company’s sales growth of hepatitis B vaccines, while the reduction in comprehensive net losses was due to the reduction in the amount of large asset impairment losses and the increase in revenue this year. https://finance.eastmoney.com/a/202503173347407027.html
- Source: drugdu
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- March 20, 2025

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