PharmaFocus Today – Page 62 – media

One innovative medical device enters special review process

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 disposable endoscopic anastomosis clip system of Guangzhou Yulin Pharmaceutical Technology Co., Ltd. (hereinafter referred to as Yulin Pharmaceutical). Accelerate the process of domestic substitution Yulin Pharmaceutical was founded in 2011 and is a technology-based medical enterprise that integrates research and development, production, sales, and after-sales service. Currently, it holds one US invention patent and more than ten domestic utility model and design patents. The factory is equipped with a 100000 level sterile production workshop and complete production facilities. Focusing on the field of obstetrics and gynecology, we are committed to providing simple and convenient clinical consumables. According to Yaozhi Patent Communication, currently Yulin Medicine has 8 authorized patents and 5 patents in the approval process, covering fields ...
- Source: drugdu
- 166
- March 5, 2025
Kangtai Biological received the summary report of the Phase I/III clinical trial of adsorbed tetanus vaccine

On the evening of March 3, Kangtai Biological (300601) issued an announcement stating that the company’s wholly-owned subsidiary Beijing Minhai Biotechnology Co., Ltd. (hereinafter referred to as “Minhai Biotechnology”) recently received the summary report of the Phase I/III clinical trial of adsorbed tetanus vaccine, and the clinical research phase of the adsorbed tetanus vaccine developed by Minhai Biotechnology was successfully completed. The results of the study showed that the adsorbed tetanus vaccine developed by Minhai Biotechnology has good safety and immunogenicity for adult immunization. Kangtai Biological said that the acquisition of the summary report of the Phase I/III clinical trial of the adsorbed tetanus vaccine shows that the adsorbed tetanus vaccine has the necessary conditions for application for production, which is of great significance to the development of the company. https://finance.eastmoney.com/a/202503033334982519.html
- Source: drugdu
- 173
- March 5, 2025
Promote the high-quality development of Chengdu-Chongqing biopharmaceutical industry and create an innovative growth pole in the west

The Chengdu-Chongqing economic circle is accelerating the construction of a biopharmaceutical industry cluster with national influence. It has formed a full industrial chain system covering R&D, production and application, and has become a key pole in the national biopharmaceutical map. However, the biopharmaceutical industry in Chengdu-Chongqing faces some problems, which restrict the release of industrial potential and affect regional coordinated development. By optimizing the review and approval mechanism of Chengdu-Chongqing biopharmaceuticals, the bottleneck of industrial development can be effectively solved. Measures such as building the Chengdu-Chongqing branch of the National Drug and Medical Device Review Center, supporting Chengdu-Chongqing institutions to obtain vaccine batch issuance qualifications, and optimizing the medical insurance negotiation mechanism can help Chengdu-Chongqing create an integrated ecosystem of “R&D-approval-application” for biopharmaceuticals, inject strong momentum into narrowing the industrial gap between the east and the west, and jointly building a western health industry base, and promote the implementation of ...
- Source: drugdu
- 168
- March 5, 2025
Breaking through new challenges in the vaccine industry with innovation and globalization

How will AI technology affect the vaccine industry? Recently, Zhu Tao, member of the National Committee of the Chinese People’s Political Consultative Conference and Chief Scientific Officer of CanSino Biologics, said in an exclusive interview with a reporter from Shanghai Securities News that with the outbreak of generative AI technology, the pharmaceutical industry is undergoing an efficiency revolution and will help solve the homogeneity dilemma. In the field of biomedicine, innovation and globalization are eternal themes. As a leading company in China’s vaccine industry, CanSino Biologics has repeatedly delivered outstanding results in recent years with its forward-looking technology research and development and international layout. Zhu Tao told reporters that the ultimate mission of Chinese vaccine companies is not just commercial success. “Our enemy is always disease.” In Zhu Tao’s view, whether it is AI empowerment or globalization, the ultimate goal is to contribute Chinese wisdom to human health. From tools ...
- Source: drugdu
- 168
- March 5, 2025
Gilead adds new liver disease drug

Recently, Gilead announced that the European Commission (EC) has conditionally approved Seladelpar for marketing in combination with ursodeoxycholic acid (UDCA) to treat patients with primary biliary cholangitis (PBC) who have an insufficient response to UDCA alone; or as a single drug to treat PBC patients who are intolerant to UDCA treatment. Seladelpar is the first and only therapy to achieve significant improvements in biochemical responses, alkaline phosphatase normalization, and pruritus relief compared to placebo. This approval means that patients with rare liver diseases in the European Economic Area (EEA) will have an important new treatment option. From the MASH dilemma to the PBC breakthrough, Seladelpar’s research and development journey has been full of twists and turns. Originally developed by CymaBay, in 2006, Johnson & Johnson and CymaBay Therapeutics reached a comprehensive development and commercialization agreement on metabolic disease drugs, and Johnson & Johnson obtained the licensing rights for three drugs ...
- Source: drugdu
- 174
- March 5, 2025
CEO of radiotherapy giant resigns

Recently, Elekta (EKTA-B.ST) announced that its President and CEO, Gustaf Salford, and board of directors have unanimously decided to resign on March 6th. The board of directors of Yikeda is conducting international recruitment for the position of new CEO. During this period, the board has appointed Jonas Bolander, Executive Vice President, General Counsel, and Group Functional Head with 23 years of experience at Medda, as Acting President and CEO. 01. Net profit decreased by 30% For the nine months ending January 31, 2025, Elekta achieved revenue of 12.86 billion Swedish kronor and a net profit of 621 million Swedish kronor. Compared to the same period last year, net profit decreased by 30% and revenue decreased by 2%. In the latest Medical Technology Top 100 Report, it ranks 56th in annual revenue. Dr. Laurent (Larry) Leksell, Chairman of the Board, stated, “Although Elekta’s mid-term performance in the third quarter did not ...
- Source: drugdu
- 173
- March 4, 2025
Seven new rare disease drugs have been given priority review, from companies such as Johnson&Johnson, Rongchang Biotech, and Hansen Pharmaceuticals

Every year’s Rare Disease Day is an important moment for us to pay attention to these ‘minority groups’. For rare disease patients, the development and approval of new drugs mean hope for life. In recent months, the China National Medical Products Administration’s Center for Drug Evaluation (CDE) has prioritized the evaluation of multiple rare disease drugs, including symptomatic giant cell tumors of the tendon sheath, myasthenia gravis, giant cell arteritis, idiopathic pulmonary fibrosis, and other indications. These drugs are expected to accelerate approval and bring new treatment options to patients. This article will review the research and development progress of 7 new drugs based on publicly available information, hoping that they will be launched soon and light up the future for rare disease patients. According to the official website of CDE, since September 2024, CDE has added a “rare disease drug” label to new drugs included in priority review. This ...
- Source: drugdu
- 444
- March 4, 2025
Hengrui steps down as the ‘top pharmaceutical expert’, and BeiGene ascends to the top for the first time! How can Hengrui break through?

Recently, Hengrui Pharmaceutical has lost its position as the “top pharmaceutical company”. On February 21st, the A-share pharmaceutical sector ushered in a historic turning point – at the closing price, BeiGene surpassed Hengrui Pharmaceutical’s 308 billion yuan market value with a market value of 310.7 billion yuan, and for the first time topped the A-share pharmaceutical company market value list with a slight advantage of 2.7 billion yuan, overturning Hengrui Pharmaceutical’s long-standing position as the “top pharmaceutical company”. BeiGene’s transcendence sends a signal. For a long time in the past, Hengrui Pharmaceutical was undoubtedly the leader in the pharmaceutical industry. With its “imitation+innovation” model, Hengrui has been leading the entire industry, and its multiple core products once occupied half of the domestic pharmaceutical market. As early as 2021, the stock price of Hengrui Pharmaceutical continued to rise after a continuous surge, reaching a peak of 96.7 yuan per share, with ...
- Source: drugdu
- 229
- March 4, 2025
Chengdu Pioneer disclosed its shareholder reduction plan; Amycritin Injection Approved for Clinical Use in China | Medical Early Reference

NO.1 Support qualified traditional Chinese medicine and other biopharmaceutical companies to issue and list on the Shanghai and Shenzhen stock exchanges The China Securities Regulatory Commission has issued a letter in response to Proposal No. 4171 (Finance, Taxation, and Finance 261) of the Second Session of the 14th National Committee of the Chinese People’s Political Consultative Conference. Among them, it is mentioned that actively supporting qualified biopharmaceutical companies, including traditional Chinese medicine, to issue and list on the Shanghai and Shenzhen stock exchanges, focusing on expanding direct financing channels for biopharmaceutical companies, and fully leveraging the supportive role of the capital market in the development of the biopharmaceutical industry. Commentary: The China Securities Regulatory Commission supports the listing of traditional Chinese medicine and other biopharmaceutical companies, expanding direct financing channels. This move will help promote innovative development in the biopharmaceutical industry, enhance the support of the capital market for the ...
- Source: drugdu
- 148
- March 4, 2025
164 measles cases have been reported in the United States

Robert Kennedy, Secretary of the U.S. Department of Health and Human Services, said he was aware of the serious impact of the current measles outbreak in Texas, and ending the measles outbreak was the top priority for him and his team. The U.S. Department of Health and Human Services will provide 2,000 doses of measles, mumps and rubella vaccines to Texas through its immunization program. According to data from the U.S. Centers for Disease Control and Prevention (CDC) on February 27, 164 measles cases have been reported in the United States, an increase of nearly 80% from the 93 cases reported a week ago. Of these cases, about 95% were from unvaccinated people, and another 3% were from people who had only received one dose and had not completed all immunizations. https://finance.eastmoney.com/a/202503013333801648.html
- Source: drugdu
- 120
- March 4, 2025

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