According to the website of the National Medical Products Administration, the National Medical Products Administration has recently conditionally approved the marketing of Ruikang Trastuzumab for Injection (trade name: Avida) submitted by Suzhou Shengdia Biopharmaceutical Co., Ltd. through the priority review and approval procedure. The single drug is suitable for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have received at least one systemic treatment in the past. The launch of this product provides a new treatment option for related patients. https://finance.eastmoney.com/a/202505293418294646.html
On Wednesday, US Eastern Time, American vaccine manufacturer Moderna announced that it had withdrawn its application for marketing authorization for the combined COVID-19 and influenza vaccine to wait for more efficacy data of its vaccine. Affected by this news, its stock price fell by more than 6% during the trading session. Moderna said it will resubmit its application later this year with effectiveness data from its standalone flu vaccine in a large-scale trial, which is expected to be released this summer. Earlier this month, Moderna claimed, largely as expected, that it did not expect regulators to approve the vaccine until 2026 because more data on its flu vaccine was needed. It is worth noting that the day before Moderna made this decision, the United States tightened the approval requirements for the new crown vaccine. The U.S. Food and Drug Administration (FDA) said that the approval of new crown vaccines for ...
On the evening of May 29, Jimin HealthManagement Co., Ltd. (hereinafter referred to as ” Jimin Health “) issued an announcement that on May 28, 2025, the company’s Boao International Hospital and Guangzhou Dabo Biological ProductsCo., Ltd. (hereinafter referred to as “Dabao Bio”) signed the “Strategic Cooperation Framework Agreement”. Founded in May 2001 and headquartered in Huangpu District, Guangzhou, Dabo Bio is a national high-tech enterprise focusing on anti-tumor gene therapy, immune cell therapy and regenerative medicine. The announcement shows that the “Strategic Cooperation Framework Agreement” mainly covers the following four aspects: first, to promote the clinical research and translational application of new biomedical technologies such as cell and gene therapy; second, to achieve the improvement of scientific research conditions and resource sharing; third, to carry out talent exchange and training; and fourth, to promote the coordinated development of the industrial chain. It is reported that the development of cell ...
In the past two years, Wantai Bio ‘s performance data has fallen off a cliff, hitting a new low since its listing. The once “star enterprise” of vaccines is experiencing the most severe performance winter in history. The core driver of the sharp drop in performance is the “big decline” in the vaccine business. Wantai Biological , which once seized the market with the first domestically produced bivalent HPV vaccine “Xinkening” , is now facing the impact of the entry of competitors such as Watson Biological and the expansion of the age range of Merck’s nine-valent vaccine squeezing the market. Faced with difficulties, Wantai Biopharmaceuticals is pinning its hopes on the nine-valent HPV vaccine, which has not yet been approved for marketing. However, this vaccine, which is planned to be a “blockbuster product”, will have to face dual competition from Merck’s “Gardasil 9” (which already covers men) and Watson Biopharmaceuticals ...
On May 27th local time, Robert F. Kennedy Jr., Secretary of the U.S. Department of Health and Human Services (HHS), announced that routine COVID-19 vaccination will no longer be recommended for healthy children and pregnant women. The U.S. Centers for Disease Control and Prevention (CDC) previously recommended that all infants 6 months and older should be vaccinated against the new coronavirus. Just a week ago, the U.S. Food and Drug Administration (FDA) announced that the agency plans to limit the use of the new crown vaccine to the elderly, children and adults with underlying medical conditions. The FDA last week released new regulatory guidance for future COVID-19 vaccine boosters, setting stricter approval standards for vaccination of healthy Americans. The FDA said that vaccines developed against new variants need to be re-approved before they can be marketed. Previously, the FDA usually approved the new crown vaccine for vaccination in all Americans ...
On May 28, Kangtai Biological (300601) issued an announcement that it had received an acceptance notice issued by the National Medical Products Administration today, agreeing to accept the clinical trial application for the trivalent influenza virus split vaccine (MDCK cells) jointly developed by the company and Lanzhou Bailing Biotechnology Co., Ltd. The vaccine is suitable for people aged 3 years and above and is intended to stimulate the body to produce immunity against influenza viruses to prevent influenza caused by related types of influenza viruses. In the first quarter of 2025, Kangtai Biological achieved revenue of 645 million yuan and net profit attributable to shareholders of the parent company of 22.43 million yuan. https://finance.eastmoney.com/a/202505283416827087.html
On May 29, Fosun Pharma announced that its independently developed Class 1 new drug Ruvometinib Tablets (trade name: Fumainin®) was officially approved for marketing by the National Medical Products Administration (NMPA). As a highly selective MEK1/2 inhibitor, Fumainin was approved for two indications for the treatment of adult patients with Langerhans cell histiocytosis (LCH) and histiocytic tumors, and children and adolescents aged 2 years and above with neurofibromatosis type I (NF1) with symptomatic, inoperable plexiform neurofibromas (PN). Fosun Pharma’s Ruvometinib has been approved for marketing, filling the gap in the treatment of rare tumors such as adult LCH. It works by blocking key signaling pathways, with impressive clinical efficacy and safety, and subsequent research and development of multiple indications is worth looking forward to. https://www.nbd.com.cn/articles/2025-05-29/3893732.html
Drugdu.com expert’s response: The development of mRNA (messenger RNA) drugs has undergone a journey from early exploration to technological breakthroughs, and then to widespread application. The specific progression is as follows: I. Early Exploration (1961-1990) In 1961, scientists first discovered mRNA. In 1987, Malone found that mRNA molecules mixed with lipid droplets could enter cells and express the desired protein, marking the beginning of RNA research as a therapeutic agent. In 1990, scientists injected in vitro-transcribed messenger RNA (mRNA) into mice and discovered that it could be expressed in vivo, producing relevant proteins in a dose-dependent manner. This method of directly injecting mRNA could induce an immune response by expressing specific proteins, serving as the prototype for mRNA therapy. II. Technological Breakthroughs (Early 21st Century-2020) Entering the 21st century, mRNA synthesis, modification, and delivery technologies further advanced. In 2005, Karikó and Weissman discovered that using modified nucleotides like pseudouridine could ...
Jianfan Bio announced on the evening of May 28 that Jianfan Biotechnology Group Co., Ltd. recently received the ” Medical DeviceThe company’s new product, disposable waste liquid bag, has obtained the second-class medical device registration certificate. This new product is a waste liquid collection device during blood purification treatment. From January to December 2024, Jianfan Bio ‘s operating income structure is as follows: medical device manufacturing accounted for 99.71%, and others accounted for 0.29%. https://finance.eastmoney.com/a/202505283416906248.html
On May 28, Kangtai Biological issued an announcement that it received an acceptance notice issued by the National Medical Products Administration today, agreeing to accept the trivalent influenza vaccine jointly developed by the company and Lanzhou Bailing Biotechnology Co., Ltd.Clinical trial application for viral split vaccine (MDCK cells). The vaccine is suitable for people aged 3 years and above and is intended to stimulate the body to produce immunity against influenza viruses to prevent influenza caused by related types of influenza viruses. In the first quarter of 2025, Kangtai Biological achieved revenue of 645 million yuan and net profit attributable to shareholders of the parent company of 22.43 million yuan. 网址:https://finance.eastmoney.com/a/202505283416827087.html
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