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A medical device is scheduled for priority approval

According to the China Medical Device Innovation and Priority Approval Database, one innovative medical device has entered the special review process in a public announcement released by local drug regulatory authorities nationwide: the strong pulse light therapy device of Dayue Innovation (Suzhou) Medical Technology Co., Ltd. (hereinafter referred to as Dayue Medical). Domestic brands are catching up Intense pulsed light (IPL), also known as pulsed light, is one of the most widely used phototherapy techniques in clinical practice and plays a very important role in the field of skin beauty. Its wavelength is mostly between 500-1200nm. At present, IPL is widely used in the treatment of various skin diseases, especially those related to photodamage and photoaging, namely the classic Type I and Type II skin rejuvenation. According to research, the theoretical basis for using strong pulsed light for skin treatment is mainly based on the principle of selective photothermal action. ...
- Source: drugdu
- 52
- March 27, 2025
481 models! 2024 FDA orphan drug certification explosion! China ranks second

According to the official website of the FDA, a total of 481 drugs obtained FDA orphan drug certification in 2024. Previously, the highest value of this number was 477. In fact, compared to over a decade ago, the number of drugs that have received FDA ODD has doubled in recent years. According to statistics, the total number of FDA ODDs since 1983 has been 7306. Among them, the number of drugs that have obtained FDA ODD has exceeded 100 since 2004 and has been increasing year by year since then. By 2017, the number of drugs that received FDA ODD had skyrocketed to 477. Between 2019 and 2023, the overall number of FDA ODDs obtained remained between 335 and 475. The number of drugs that have obtained FDA ODD in 2024 has broken through from the previous 2017 data, reaching 481. According to the latest data, although it has only ...
- Source: drugdu
- 53
- March 27, 2025
Zhifei Bio invested 593 million yuan to acquire Chen’an Bio and enter the field of metabolic disease medicine

Recently, Zhifei Bio announced that in order to deepen the company’s self-developed technology and product layout in biopharmaceuticals and create the goal of “a world-class biopharmaceutical company”, the company signed a capital increase and share expansion agreement with Chongqing Chen’an Biopharmaceutical Co., Ltd. (referred to as “Chen’an Bio”), Chongqing Zhirui Investment Co., Ltd. (referred to as “Zhirui Investment”), and Zhanggaoxia on March 21, and will increase the capital of Chen’an Bio by approximately 593 million yuan in cash and acquire 51% of its equity. After the completion of this capital increase, Chen’an Bio will become a holding subsidiary of the company. 593 million yuan to acquire 51% equity This capital increase is based on the valuation results in the “Appraisal Report” issued by an asset appraisal agency with securities and futures business qualifications. It is determined through negotiation that the value of 100% equity of Chen’an Bio before this capital ...
- Source: drugdu
- 64
- March 27, 2025
Minsheng Health obtains drug registration certificate for Minoxidil Lotion

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
- Source: drugdu
- 44
- March 27, 2025
Gadoteric Acid Glucoamine Injection Obtains Drug Registration Certificate

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
- Source: drugdu
- 45
- March 27, 2025
The vaccine leader invested nearly 600 million yuan to increase its investment in the pneumococcal track. The real-time transaction volume of the Hong Kong Stock Innovative Drug ETF (159567) was nearly 100 million yuan.

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 ...
- Source: drugdu
- 53
- March 27, 2025
CPhI India

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 ...
- Source: drugdu
- 62
- March 27, 2025
The Yunding Xinyao therapeutic cancer vaccine has been approved for clinical use; Shenji Changhua’s drug for treating ALS has been approved for clinical use

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 ...
- Source: drugdu
- 51
- March 26, 2025
4 deaths and 17 injuries! Medtronic star products are subject to a first level recall

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, ...
- Source: drugdu
- 53
- March 26, 2025
WuXi AppTec responds that no AI is needed to develop new drugs! A large number of CXOs are eager to embrace the wave of the times

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 ...
- Source: drugdu
- 43
- March 26, 2025

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