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1 medical device enters the priority approval green channel

Recently, the Equipment Review Center of the National Medical Products Administration released the results of the priority approval application for medical devices (No. 16 of 2024), and the product of Beijing Wantai Biopharmaceutical Co., Ltd. (hereinafter referred to as Wantai Bio) – Human Immunodeficiency Virus 1+2 Urine Anti physical Examination Test Kit (Colloidal Gold Method) has entered the priority approval green channel. It is worth mentioning that this product belongs to the category of “medical devices listed in the National Science and Technology Major Special Project”. Layout HIV testing Since the Joint United Nations Programme on AIDS (UNAIDS) put forward the “90-90-90” HIV prevention and control goal in 2013, it aims to end the AIDS epidemic in the world by 2030. WHO strongly recommends that countries carry out routine HIV testing and promote HIV self inspection as a supplement to routine HIV testing, so as to jointly realize the first ...
- Source: drugdu
- 68
- December 4, 2024
Artificial cochlear implant leader, impacting IPO!

Recently, according to the official website of the China Securities Regulatory Commission, Zhejiang Norkang Neuro Electronic Technology Co., Ltd. (hereinafter referred to as “Norkang”) has registered for coaching with the Zhejiang Securities Regulatory Bureau, and the coaching securities firm is Guotai Junan. Three Battles IPO Norkon was founded in 2006 and is a high-tech enterprise that produces and operates neuroelectronic medical devices. It integrates independent research and development, production, and sales. The company focuses on the field of neural electrical stimulation, adhering to independent research and innovation. Its products are divided into two directions: neural prostheses and neural regulation. Currently, it has formed a development layout of four product lines: auditory reconstruction products, visual reconstruction products, urinary system regulation, and brain system regulation. According to the coaching filing report, Chairman Li Fangping directly holds 13.43% of the shares of Norkang, indirectly holds 2.41% of the shares of Norkang through Hangzhou ...
- Source: drugdu
- 76
- December 4, 2024
Three giants of IL-23, “making a big splash” in the ulcerative colitis market

Although global sales will exceed US$20 billion in 2023, the market ceiling for IL-23 inhibitors seems to be far from coming. The expansion of new indications remains the key to continued sales growth. Since 2023, Eli Lilly’s Mirikizumab, AbbVie’s Skyrizi and Johnson & Johnson’s Tremfya have been approved for UC (ulcerative colitis) indications and have quickly entered this market. According to a report released by Spherix Global Insights, IL-23 inhibitors have gained significant development momentum since their entry in 2023 and have occupied one-tenth of the UC market share in 2024. The above figures confirm the predictability of IL-23 inhibitors in the UC market. After all, in the highly competitive UC market, such growth is rare. But at the same time, as the number of competitors increases, different IL-23 inhibitor markets also need to worry about market share in the UC market. The competition has quietly begun. It is not ...
- Source: drugdu
- 70
- December 4, 2024
China’s bispecific antibodies compete in the multi-billion dollar race

The 66th American Society of Hematology (ASH) will be held in San Diego, USA from December 7 to 10, 2024. As one of the largest and most comprehensive international academic events in the field of hematology, it announces and publishes the latest hematology advances from all over the world every year. Multiple myeloma (MM), as the second most common hematological malignancy, has attracted the attention and layout of various pharmaceutical companies. At this year’s ASH conference, several Chinese bispecific antibodies/trispecific antibodies will be unveiled for MM indications. MM: The birthplace of the billion-dollar miracle drug Multiple myeloma is the second most common hematological malignancy after non-Hodgkin’s lymphoma. It is a malignant clonal plasma cell proliferative disease that causes extensive bone destruction, accompanied by osteolytic lesions, osteopenia and pathological fractures. It is called a blood disease that “eats” bones. According to the Chinese Multiple Myeloma Diagnosis and Treatment Guidelines (revised in ...
- Source: drugdu
- 69
- December 4, 2024
【EXPERT Q&A】What is the process of registering Pakistan DRAP certificate?

Drugdu.com expert’s response: The process of registering for a DRAP (Drug Regulatory Authority of Pakistan) certificate involves multiple steps. Below is a detailed outline of the registration process: Ⅰ. Preliminary Preparations Understanding Regulations: Familiarize yourself with the relevant regulations and guidelines of the Pakistani medical device regulatory authority, DRAP. Understand the classification of medical devices, registration requirements, technical standards, etc. Determining Classification: Based on Pakistan’s medical device classification system, determine which category the medical device to be registered falls into. Registration requirements may vary for different categories of medical devices. Establishing Systems: Ensure that the production process and quality control of medical devices comply with international quality management standards, such as ISO 13485. This will help improve the success rate of registration and market competitiveness. Ⅱ. Preparing Application Materials Product Technical Documents: Including product specifications, technical specifications, performance indicators, etc. Quality Management System Documents: Such as ISO 13485 certificates, proving ...
- Source: drugdu
- 64
- December 4, 2024
Received Approval Notification for Clinical Trials of Adsorbed Tetanus Vaccine

On December 2, Walvax Biologics announced that its joint application with its holding subsidiary, Yuxi Walvax Biotechnology Co., Ltd., for clinical trials of an adsorbed tetanus vaccine has recently received the “Drug Clinical Trial Approval Notification” issued by the National Medical Products Administration. After review, the adsorbed tetanus vaccine accepted on September 2, 2024, complies with the relevant requirements for drug registration and is approved to conduct clinical trials for the prevention of tetanus. https://finance.eastmoney.com/a/202412023256655359.html
- Source: drugdu
- 63
- December 4, 2024
Xiansheng Pharmaceutical’s Innovative Brain Cell Protection Drug Approved for Market

On December 1, Xiansheng Pharmaceutical’s innovative brain cell protection drug, Xianbixin sublingual tablets, was approved for market launch. Xianbixin is a dual-target brain cell protector that contains two active ingredients: Edaravone and R-(-)-Borneol. These ingredients work synergistically to enhance both antioxidant and anti-inflammatory effects, significantly reducing brain cell damage caused by acute ischemic stroke. In 2020, Xiansheng Pharmaceutical launched a Class 1 innovative drug, Xianbixin (in injectable form) in China, making it the only innovative drug approved in the stroke field globally in nearly a decade. https://finance.eastmoney.com/a/202412023256274687.html
- Source: drugdu
- 59
- December 4, 2024
There is one more loser in the AD field

There is one more loser in the Alzheimer’s disease field. On November 25, Cassava Sciences announced that the Phase III ReThink-ALZ study of Simufilam for the treatment of mild to moderate Alzheimer’s disease (AD) did not meet the pre-set dual primary endpoints, secondary endpoints, and exploratory biomarker endpoints. Affected by this news, Cassava Sciences’ stock price fell 84% that day. It seems that this may be expected. Cassava Sciences has been in great controversy because of controversies such as paper data falsification. But in any case, this still highlights the difficulty of treating Alzheimer’s disease. Simufilam is an oral small molecule drug targeting misconstructed filament protein A (FLNA). FLNA is a scaffold protein that normally exists in cells. The toxic form of amyloid beta, Aβ42, can induce changes in its structure, and the misconstructed FLNA can promote the activation of the Aβ42-α7 acetylcholine receptor signaling pathway and the Aβ42-Toll-like receptor ...
- Source: drugdu
- 77
- December 3, 2024
Allogeneic CAR-T heats up again

In the past week, the field of allogeneic CAR-T has heated up again due to the participation of Roche. On November 26, Roche announced that it would acquire the biotech company Poseida for up to $1.5 billion. Poseida’s R&D pipeline includes spot (allogeneic) CAR-T therapies in multiple therapeutic areas, covering hematological malignancies, solid tumors and autoimmune diseases. Due to a series of factors such as cycle and cost, the commercialization process of autologous CAR-T has been subject to certain restrictions, so the industry has never stopped exploring allogeneic CAR-T. The market has high hopes for allogeneic CAR-T. Of course, this is not smooth sailing, because due to a series of factors such as effect, it will take some time for allogeneic CAR-T to break through. Roche’s investment in Poseida this time is mainly based on the latter’s technology platform. Poseida’s non-viral platform is able to generate off-the-shelf CAR-T therapies ...
- Source: drugdu
- 71
- December 3, 2024
Changes in the Core of Medical Insurance Negotiations

After several years of practice, the thinking of medical insurance negotiations has completely changed. Drug prices still need to be controlled, and exchanging volume for price is the unshirkable responsibility of the Medical Insurance Bureau as a large buyer. However, the tone of the negotiations has changed. In the past few years, the Medical Insurance Bureau emphasized “soul bargaining”; but in this year’s medical insurance negotiations, the official tone of the Medical Insurance Bureau has become “two-way running.” “Going in both directions” means no longer just pursuing low prices, but negotiating with a reasonable price and stable expectations. For medical insurance, including more high-quality drugs through negotiations with pharmaceutical companies is to strive for the maximum benefits for insured persons on the basis of maintaining the stable operation of the fund; and for pharmaceutical companies, entering medical insurance can usually show significant benefits. By increasing sales, the commercialization process can ...
- Source: drugdu
- 74
- December 3, 2024

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