On March 10, Yifang Biopharma (688382) announced that on March 8, 2025, the Phase II clinical study results of the company’s independently developed TYK2 inhibitor D-2570 for the treatment of moderate to severe plaque psoriasis were released in the form of an oral report in the latest breakthrough research abstracts section of the 2025 American Academy of Dermatology Annual Meeting. In terms of safety, D-2570 was generally well tolerated, most adverse events were mild to moderate, and no serious adverse events were reported. Its safety profile is similar to other TYK2 inhibitors, and no new safety signals were found. In addition, data from Phase II clinical studies showed that D-2570 is significantly better than placebo in treating patients with moderate to severe psoriasis, and is also better than similar TYK2 inhibitors currently on the market. It is also comparable in effectiveness to antibody biologics (such as anti-IL-17A and anti-IL-23 antibodies). ...
As the most popular self-paid vaccine in the past few years, when the HPV vaccine can become a public product for all has always been the focus of social attention. At the National People’s Congress in recent years, deputies and members have continued to make suggestions on this. Nandu reporters learned that last year, the relevant suggestions were listed as key supervision suggestions by the National Health Commission. This year, deputies and members continued to speak out on this and called for the inclusion of HPV vaccines in the national immunization plan. Because it can prevent cervical cancer, HPV vaccines have been sought after since their birth. The countries that first introduced the vaccination plan have observed a significant decline in HPV infection rates and cervical precancerous lesions. The World Health Organization recommends that 90% of girls should be vaccinated with HPV vaccines before the age of 15 by 2030 ...
Drugdu.com expert’s response: The Medical Device Single Audit Program (MDSAP) audit process is a systematic and standardized procedure designed to ensure that medical device manufacturers’ quality management systems comply with the regulatory requirements of various countries/regions participating in the MDSAP. Below is a detailed introduction to the MDSAP audit process and its contents: I. Audit Process Preparation Stage Understanding MDSAP Requirements: Firstly, enterprises need to thoroughly understand the MDSAP requirements, including the regulations, standards, and specific requirements of each participating country & region involved. Internal Audit and Preparation: Enterprises must conduct an internal audit of their quality management system to ensure it has been established and maintained in compliance with MDSAP requirements. This includes preparing necessary documents and materials such as quality management manuals, procedure documents, and records. Selecting an Audit Organization: MDSAP certification requires audits to be conducted by third-party audit organizations accredited by the International Medical Device Regulators Forum (IMDRF). Enterprises ...
The China Respiratory Science Development Conference pointed out that chronic respiratory problems, represented by chronic obstructive pulmonary disease (COPD), have become the most prominent and severe public health problem in China, with a prevalence rate of 13.7% among people over 40 years old. According to the “Research Report on the Development Trends and Strategies of the Domestic Oxygen Generator Industry from 2023 to 2028” by China Research Institute of Industry, the demand for precision oxygen therapy in the home oxygen therapy market is continuously increasing. Weihai Weigao Health Technology Co., Ltd., a subsidiary of Weigao Group, has taken the lead in launching the first automatic oxygen controlled (AOT) oxygen concentrator to meet the precise oxygen therapy needs of patients, leading the industry development and helping medical progress. 01. Innovative automatic oxygen control technology breaks the limitations of constant oxygen production Traditional oxygen concentrators lack a dynamic adjustment mechanism, making it ...
Recently, the Jiangsu Provincial Medical Products Administration released the “Announcement of the Examination Results of Priority Approval Applications for Class II Medical Devices (No. 3 of 2025)”, intending to approve the priority registration process for the ultraviolet phototherapy device of Xuzhou Kono Medical Instrument Equipment Co., Ltd. (hereinafter referred to as “Kono Medical”). Heavy equipment, registration process accelerates Ultraviolet radiation is an invisible light with a wavelength between 100-400nm, which can be divided into UVC radiation (100-280nm), UVB radiation (280-320nm), and UVA radiation (320-400nm). Ultraviolet radiation has sufficient energy to destroy the DNA structure of microorganisms, thus effectively inhibiting the activity of viruses and bacteria. Research has shown that ultraviolet radiation has the effects of accelerating blood circulation, relieving pain, and promoting epithelial regeneration, making it effective in treating diseases such as herpes, psoriasis, and atopic dermatitis. In addition, ultraviolet radiation also promotes the production of vitamin D, which can ...
Seladelar is currently the first and only therapy that has achieved significant improvements in biochemical reactions, normalization of alkaline phosphatase, and relief of itching compared to placebo. This approval means that rare liver disease patients in the European Economic Area (EEA) will have an important new treatment option. From MASH dilemma to PBC breakthrough The development process of Seladelar is full of twists and turns. Originally developed by CymaBay, in 2006, Johnson&Johnson reached a comprehensive development and commercialization agreement with CymaBay Therapeutics for metabolic disease drugs. Johnson&Johnson obtained authorization for three drugs, including Seladelar. In February 2024, Geely Dehao invested $4.3 billion to acquire CymaBay Therapeutics, acquiring the core pipeline drug Seladelar. On August 9, 2024, just one week before the FDA PDUFA date of Seladelar in the United States (August 14), Gilead quickly made a move and purchased Seladelar’s global royalties from Johnson&Johnson for $320 million. Behind this series ...
Source of Medicine Intelligence Network: Medicine Intelligence Network Recently, Shize Biotechnology announced that its self-developed universal iPSC derived subtype neural precursor cell injection product XS-228 injection has been fully approved by the US FDA for registration in clinical trials for the treatment of amyotrophic lateral sclerosis (ALS). This breakthrough not only marks an innovative breakthrough in the field of cell therapy in China, but also brings new hope to patients with ALS. One of the ‘Four Deadly Diseases of the World’ ALS, as one of the “Four Deadly Diseases of the World”, its complexity and harmfulness cannot be ignored. ALS (amyotrophic lateral sclerosis) is a rare and progressive neurodegenerative disease that primarily affects motor neurons in the brain and spinal cord. These neurons are responsible for controlling muscle movement. As they gradually regress and die, patients may experience symptoms such as muscle weakness, atrophy, and stiffness, ultimately leading to the ...
On March 10, Pfizer announced that the targeted immunotherapy Iregio® (Enatuzumab) was conditionally approved by the National Medical Products Administration for the treatment of adult patients with relapsed or refractory multiple myeloma who had previously received at least three lines of treatment (including a proteasome inhibitor, an immunomodulator, and an anti-CD38 monoclonal antibody). https://finance.eastmoney.com/a/202503103341149628.html
On March 10, AbbVie announced that the China National Medical Products Administration (NMPA) approved Cialis® for the treatment of adult patients with moderate to severe active Crohn’s disease who have insufficient response, loss of response or intolerance to traditional treatment or biologics. The approval includes two dosage forms: risankizumab injection and risankizumab injection (subcutaneous injection). Cialis® is the world’s first interleukin-23 (IL-23) inhibitor approved for adult patients with moderate to severe active Crohn’s disease. After approval, it is also the first IL-23 inhibitor in China with a portable dosing device. https://finance.eastmoney.com/a/202503103341127889.html
“The drug name on the hospital’s external prescription is the same as the drug in the pharmacy, why can’t I buy it?” “Why can’t the community health center issue an external prescription, and I have to go to the hospital?” Recently, the Shenzhen Medical Insurance Bureau launched a new “dual channel” drug management regulation, taking the lead in the province to upgrade the circulation of external prescriptions from “trade name” to “generic name”, and launched the community health external prescription circulation service. These problems that once troubled the general public are being solved. “Dual channel” drugs refer to national medical insurance negotiated drugs with high clinical value, urgent need for patients, and low substitutability. There are currently more than 600 kinds in Shenzhen. In order to ensure the patient’s drug needs, when such drugs are not available in the hospital, they can be purchased at the pharmacy through external prescriptions, ...
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