On March 24, Minsheng Health issued an announcement that the company recently received a drug registration certificate for Minoxidil Lotion approved and issued by the State Drug Administration. The drug includes two specifications: 2% (60 ml: 1.2 g) and 5% (60 ml: 3.0 g), which belongs to Class 3 chemical drugs. The registration standard number is YBH04342025. The drug is valid for 24 months and the approval number is valid until March 17, 2030. The drug registration certificate obtained this time will help the company enrich its product categories and enhance its market competitiveness. Minoxidil Lotion is an over-the-counter drug for dermatology, mainly used to treat male pattern baldness and alopecia areata, and has certain market potential. However, the pharmaceutical sales business also faces uncertainties such as changes in domestic pharmaceutical industry policies and market competition, and investors need to remain rational. https://finance.eastmoney.com/a/202503243354324122.html
On March 25, China Resources Double Crane announced that the company had received the Drug Registration Certificate for Gadoteric Acid Glucoamine Injection issued by the State Drug Administration. The drug is suitable for MRI examinations of diseases such as brain and spinal cord lesions and spinal lesions. The company started the research and development of generic drugs for the drug in May 2022, submitted an application for marketing authorization on June 15, 2023, and was approved for listing on March 18, 2025. As of the announcement date, the company’s cumulative R&D investment in the drug was RMB 8.0652 million. In 2023, the total sales of Gadoteric Acid Glucoamine Injection in the domestic medical market and retail market were RMB 590 million, of which Jiangsu Hengrui Medicine had a market share of 89.46% and France Guerbet had a market share of 10.54%. https://finance.eastmoney.com/a/202503253355613226.html
As of 10:09 on March 25, 2025, the performance of the CSI Hong Kong Stock Connect Innovative Drug Index is worth noting. The constituent stocks rose and fell, with Conoya-B (02162) leading the rise of 6.45%, Rongchang Bio (09995) rising 5.40%, and Immune Onco-B (01541) rising 5.37%. The latest quotation of the Hong Kong Stock Innovative Drug ETF (159567) is 1.15 yuan, with an intraday transaction volume of nearly 100 million yuan and a turnover rate of over 17%. Minsheng Securities said that it actively pays attention to the subdivision direction of AI medical care + early tumor screening, which has a large market space and high barriers. The continuous upgrading of AI technology is expected to optimize detection performance and achieve application breakthroughs. The commercialization of early cancer screening products overseas has achieved initial results. Domestic attention is paid to the upstream domestic substitution and mid- and downstream application ...
Organiser: Informa Markets Time: November 25-27, 2025 Address: Plot No. 25, 27, 28, 29, Knowledge Park II, Greater Noida, Uttar Pradesh 201306, India Exhibition hall: Greater Noida Product range: APIs: Vitamins, Hormones, Sulfonamides, Analgesics & Antipyretics, Tetracyclines, Amino Acids & Derivatives, Chloramphenicols, Digestive System Drugs, Anti-Infectives, Penicillins, Aminoglycosides, Lincomycins, Cardiovascular Drugs, Antiparasitics, Cephalosporins, Macrolides, Respiratory Drugs, Central Nervous System Drugs, Other Western APIs. Packaging & Equipment: Pharmaceutical Machinery, Packaging Machinery, Packaging Materials, Drug Production Equipment & Technology, Pharmaceutical Packaging Systems, Cleaning/Sterilization Systems, Laboratory Instrumentation. Pharmaceutical Products: Traditional Chinese Medicines, Western Drugs, New Drugs, Chemical Pharmaceuticals, Intermediates, Biopharmaceuticals, Herbal Medicines, Plant/Animal Extracts, Veterinary Drugs, Food Ingredients & Additives. About CPhI India: The CPhI India World Pharmaceutical Ingredient Exhibition is South Asia’s most influential trade fair for pharmaceutical ingredients and machinery. Serving as a premier platform for industry innovation, it connects businesses with India’s leading stakeholders in pharmaceutical machinery, technology, and raw materials. Attendees gain insights ...
NO.1 Yunding Xinyao Cancer Vaccine Approved for Clinical Use in the United States Yunding Xinyao announced that its universal tumor therapeutic vaccine EVM14 injection has received FDA approval for its IND (New Drug Clinical Trial Application). According to the press release, EVM14 is the company’s first independently developed new drug to receive FDA IND approval. EVM14 is a universal tumor therapeutic vaccine targeting multiple tumor associated antigens (TAA), intended for the treatment of various cancers such as non-small cell lung cancer and head and neck cancer. Comment: Therapeutic vaccines differ from traditional preventive vaccines in that they aim to activate the patient’s immune system to combat pre-existing diseases. EVM14 has been approved for clinical use, opening up new ideas for cancer treatment. It can make up for the limitations of traditional treatment, stimulate patients’ own immunity to fight against tumors, induce immune memory to reduce the risk of recurrence ...
Recently, the FDA announced a first level recall of Medtronic’s flagship product, the Pipeline Vantage series embolization device. It is reported that the US FDA has listed the recall of the Medtronic (NYSE: MDT) Pipeline Vantage embolization device as the highest level of alert, as the product has initiated an emergency recall procedure due to multiple fatal cases. This recall includes two key measures: complete discontinuation and removal of Pipeline Vantage 027 embolization device; Update the usage guide for Pipeline Vantage 021 device. This series of neurointerventional devices using shielding technology are mainly used for treating intracranial aneurysm like lesions (aneurysms). Its working principle is to deliver the braided stent to the lesion site through a microcatheter, and block the blood flow of the aneurysm using a mesh structure. According to the FDA announcement, this recall is due to adverse stent adherence events that occur frequently in clinical use. Specifically, ...
Affected by this news, both A-shares and H-shares of WuXi AppTec rose on the same day, with A-shares hitting the daily limit up at one point. As of the close, WuXi AppTec’s A-share market price was 69.68 yuan/share, up 8.82%, with a market value of 2021 billion yuan; The Hong Kong stock market quoted 71.95 yuan per share, up 9.93%, with a market value of 207.8 billion yuan. Not only WuXi AppTec, but also companies such as Kanglong Huacheng, Chengdu Pioneer, and Hongbo Pharmaceutical actively embrace AI technology. These CXO giants have coincidentally ventured into the AI field, and what insights do they have for the industry? Medication strategy: HI+AI Thanks to its contract outsourcing model, CXO has significantly reduced research and production costs and improved research and development efficiency for the pharmaceutical industry, making it highly respected in the industry. However, the industry still inevitably faces many uncertain factors ...
Drugdu.com expert’s response: DCS (Distributed Control System) is the core automation system in pharmaceutical manufacturing, requiring adherence to three critical objectives: compliance, data integrity, and system reliability. Below is a detailed breakdown based on international regulations, industry practices, and technical requirements: I. International Regulations & Industry Standards GMP Compliance FDA 21 CFR Part 11: Mandates electronic records and signatures, ensuring DCS data storage, modification, and audit trails meet regulatory standards. EU GMP Annex 11: Focuses on computerized system validation, including access control, data backup, and cybersecurity. ICH Q9/Q10: Risk-based quality systems requiring DCS to identify Critical Process Parameters (CPPs) and mitigate quality risks. GAMP 5 Guidelines: Classifies DCS as Category 4 (Configurable Software), requiring full lifecycle validation (URS, FAT, SAT, IQ/OQ/PQ). ISO Standards ISO 9001: Ensures quality management for DCS suppliers. ISO 27001: Protects DCS from cyber threats via information security protocols. II. Technical & Functional Requirements Data Integrity (ALCOA+ Principles) Traceability: Full operational ...
Johnson & Johnson to Invest $55 Billion in U.S. Healthcare Infrastructure By Thomas Yuan WILSON, N.C. — In a sweeping move to reinforce America’s life sciences sector, Johnson & Johnson announced on March 21 that it will invest more than $55 billion in its pharmaceutical and medical technology business across the United States over the next four years — a 25 percent increase from its previous investment cycle. The investment, the company said, aims to bolster U.S. manufacturing, research and development, and innovation in fields like oncology, neuroscience, and robotic surgery. It comes as part of a broader effort to maintain America’s global leadership in medical supply and health products, at a time when governments are emphasizing domestic production in response to geopolitical tensions and lessons learned from the pandemic. “We are committed to addressing the world’s toughest healthcare challenges,” said Joaquin Duato, Chairman and CEO of Johnson & Johnson, ...
Solventum Undertakes $120 Million Overhaul in Strategic Bid for Growth By Thomas Yuan ST. PAUL, Minn. — Solventum, the healthcare spin-off of industrial giant 3M, has entered a new chapter of independence with a bold restructuring effort aimed at reshaping its organizational DNA and strengthening its position in the global medical technology landscape. The company has spent $120 million on its transformation plan — but expects to recoup the entire amount in annual operating cost savings. In a recent investor briefing, Solventum reported that the savings generated in the first year alone will be “sufficient to cover the incremental expenses” of its operations as a newly public company. “This restructuring is not just about cost,” said a company spokesperson in an interview with The Star. “We are optimizing strategic resource allocation to drive long-term business expansion. Our Minnesota-based workforce continues to grow.” From Legacy to Leadership The restructuring, which ...
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