Recently, the National Healthcare Security Administration issued the “Several Measures to Support the High Quality Development of Innovative Drugs”, which clarifies the full chain support for the development of innovative drugs from research and development, admission, payment, etc. In this context, cell therapy, as a highly breakthrough innovative therapy in the field of biomedicine, is expected to further enhance the accessibility and affordability of its products. The Measures propose to encourage innovative drugs to conduct real-world research and link research results with medical insurance admission and renewal, promoting the application of real-world data in medical insurance admission. Of the 91 new drugs newly included in the medical insurance catalog in 2024, 33 were approved, launched, and included in the catalog that year, and innovative drugs are accelerating their integration into the medical insurance system. The clinical data accumulated through real-world research can more comprehensively verify the efficacy and safety of ...
Zhongzheng Smart Finance News: Zhuhai Zhuhui Biological – B (02627) announced in the morning of August 13 that according to the announcement of the National Healthcare Security Administration on August 12, the company’s quadrivalent influenza virus subunit vaccine, Huier Kangxin, has been included in the preliminary review list of innovative drugs for commercial health insurance in the country this year. It is the only vaccine product on the list. This vaccine was approved for marketing by the National Medical Products Administration in May 2023 and is suitable for people aged three and above (with a hemagglutinin concentration of 15μg/0.5ml for the virus strain). It is the first and only quadrivalent influenza virus subunit vaccine in China, providing broad protection against influenza viruses of type A H1N1, H3N2 and type B Yamagata and Victoria. The product is an optimized and upgraded version of traditional split vaccines, featuring comprehensive protection, high antigen ...
Recently, Genentech, a subsidiary of Roche, announced the termination of its cooperation agreement with Bicycle Therapeutics. This decision will officially take effect in August. Genentech has had an exclusive partnership with Bicycle since February 2020, when Bicycle received a down payment of $30 million and is expected to receive a total transaction value of up to $1.7 billion (approximately RMB 12.2 billion) after Genentech reaches certain R&D milestones. However, the cooperation failed to proceed smoothly. Since 2023, Genentech has successively terminated several projects in the cooperation, until now it has completely stopped the cooperation. The reasons for the termination of the collaboration include, on the one hand, Genentech’s readjustment of project priorities and its gradual reduction of investment in Bicycle’s projects. On the other hand, Bicycle’s technology platform has certain limitations. Peptide screening is more difficult than antibody screening, and its shorter half-life limits development efficiency. Compared to antibody-drug conjugates ...
August 12, Hisense(002653) announced that the company recently received the “Notice of Approval for Drug Clinical Trial” issued by the National Medical Products Administration, approving its independently developed innovative drugHSK47977 tablets are undergoing clinical trials. This drug is an oral BCL6 PROTAC small molecule formulation, primarily used to treat non-Hodgkin’s lymphoma, and meets the relevant drug registration requirements. HSK47977 tablets have no clinically active drugs targeting the same target in China, and they hold the potential to become a first-in-class product. The company completed Pre-IND discussions with the FDA in July 2025 and submitted an IND application, with the potential for simultaneous development in China and the US. Preclinical studies have demonstrated potent anti-tumor activity and a favorable safety profile, demonstrating high development potential. In the first quarter of 2025, Hisense achieved revenue of 892 million yuan and net profit attributable to shareholders of the parent company of 46.61 million ...
TUESDAY, Aug. 12, 2025 (HealthDay News) — A new vaccine aimed at a common cancer gene mutation could help stop aggressive pancreatic cancers from coming back, a small clinical trial suggests. Pancreatic cancer is one of the most lethal cancers, with a five-year survival rate of about 13%, according to the American Cancer Society. Further, up to 80% of cases return after treatment, the National Institutes of Health says. “If you were to ask me what disease most needs something to prevent recurrences, I’d say this one,” Dr. Zev Wainberg, a leader of the trial, told NBC News. He’s co-director of the University of California, Los Angeles, gastrointestinal oncology program. The experimental vaccine targets KRAS gene mutations, which are found in about 25% of all cancers, the University of Texas MD Anderson Cancer Center says. This includes up to 90% of pancreatic cancers and roughly 40% of colon cancers. While ...
The FDA has approved Insmed Incorporated’s Brinsupri (brensocatib), marking the first and only therapy indicated for non-cystic fibrosis bronchiectasis (NCFB) in adults and adolescents aged 12 years and older.1 FDA Approves Brinsupri as First Treatment for Non-Cystic Fibrosis Bronchiectasis The regulatory action was based on positive results from the Phase III ASPEN (NCT04594369)2 and Phase II WILLOW trials (NCT03218917),3 both of which were published by The New England Journal of Medicine (NEJM).4,5 In these trials, Brinsupri was found to significantly reduce exacerbation rates, delay time to first flare, and preserve lung function compared to placebo. “The FDA approval of the first-ever treatment for non-cystic fibrosis bronchiectasis is a historic milestone for patients and for Insmed,” Martina Flammer, MD, MBA, Chief Medical Officer of Insmed, said in a press release. “By keeping patients at the center of everything we do, we have once again delivered a first-in-class medicine for a disease ...
A research team at McMaster University has discovered a new drug class that could someday lead to breakthrough treatments for dangerous fungal infections. The new molecules, dubbed coniotins, were isolated from a plant-dwelling fungus called Coniochaeta hoffmannii – the samples of which were collected from the McMaster greenhouse, located on the university’s campus. Detailed recently in the journal Nature Communications, the discovery responds to a critical need for new antifungal medicines. There is a huge, growing clinical need for new drugs that target fungal infections. Unlike antibiotics, of which there are dozens of different classes approved for use in clinics, there are really only three classes of antifungals on the market right now.” Gerry Wright, a professor of biochemistry and biomedical sciences at McMaster and principal investigator on the new study The reason for such a limited arsenal, Wright says, is two-fold. First, although disease-causing fungi are microscopic like bacteria ...
By Lori Solomon HealthDay ReporterMONDAY, Aug. 11, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved the single-dose Ajovy (fremanezumab-vfrm) injection for the preventive treatment of episodic migraine in children and adolescents. In the United States, one in 10 children and adolescents experience migraine, a common but often underrecognized and undertreated condition that can cause missed school, academic challenges, and social disruptions. Ajovy is the first and only calcitonin gene-related peptide antagonist approved for pediatric episodic migraine prevention and migraine prevention in adults. Ajovy is authorized for adults and children/adolescents aged 6 to 17 years and weighing at least 45 kg (99 lb). Ajovy is a 225-mg/1.5-mL single-dose injection, available in a prefilled autoinjector or syringe, and can be given by a health care professional or self-administered or administered by a parent or caregiver in the home environment. “Pediatric migraine is a complex condition that can significantly ...
On the 11th, Nature Medicine published a phase 1 clinical trial conducted by the research team of the University of California, Los Angeles. The results showed that a non individualized, mass produced, ready to use peptide vaccine called ELI-002 2P was helpful to extend the long-term relapse free survival of some patients with pancreatic cancer or colorectal cancer. It is known that the recurrence rate of pancreatic cancer and colorectal cancer is high even after surgery and chemotherapy, especially when there are trace cancer cells left in the body. The design of cancer vaccines aims to stimulate immune cell T cells, specifically recognize and kill cancer cells, and personalize targeting of tumor proteins in patients. KRAS gene in pancreatic cancer and colorectal cancer often carries mutations, which plays a key role in cancer growth, so it is an ideal target for cancer vaccines and other immunotherapies. Although inhibitors and T ...
On the evening of August 11, Huaxi Bio(688363) announced that the company’s independently developed fermentation-based chondroitin sodium raw material (hereinafter referred to as “chondroitin sodium”) has successfully passed the National Medical Products Administration’s Medical Device Approval.The company has registered its master document with the Technical Review Center and has become the first company in my country to achieve regulatory compliance for its fermentation-based chondroitin sodium. Huaxi Bio said that the sodium chondroitin that has been registered this time is a new type of pharmaceutical-grade raw material of the company and can be used in Class II and Class III medical devices . It is expected to provide core raw materials for high-end medical devices in the future . It is reported that traditional chondroitin sulfate is mainly extracted from animal cartilage (such as pig, cow, chicken, and shark), which has problems such as animal immunogenicity, unsustainable raw material sources, and ...
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