On April 21, the company held a performance briefing for 2024 and the first quarter of 2025. Kong Wei, Vice Chairman of the Company, Jiang Chunlai, Director and General Manager, and Zhang Zhe, Secretary of the Board of Directors, interacted and communicated with investors on the specific situation of the operating results and financial indicators for 2024 and the first quarter of 2025. Beike Bio is a high-tech biopharmaceutical company specializing in the research and development, production and sales of human vaccines. The company currently has approved vaccine products such as varicella vaccine, nasal spray influenza vaccine, and shingles vaccine. Among them, the market share of varicella vaccine has been in the leading position for many years; the nasal spray influenza vaccine is a project of the World Health Organization (WHO) Global Influenza Action Plan (GAP), and is the only influenza live attenuated vaccine in China that is administered by ...
Organiser:ITE Group (UK) Time:May 21-23, 2025 address:ul. Zipovskaya, 5, Krasnodar, 350010, Russia Exhibition hall:Krasnodar Expo Center Product range: Medical: Medical supplies, medical products, medical consumables, medical equipment Rehabilitation: Elderly rehabilitation, rehabilitation equipment and materials, rehabilitation medical services, rehabilitation training, rehabilitation devices, aids and equipment for the disabled Health Care: Health supplements, health appliances, health foods, health-related equipment About Dentima Krasnodar: The Russian Medical Exhibition (Dentima Krasnodar) is one of the leading medical exhibitions in the southern region of Russia. Every year, it brings together doctors, manufacturers, and suppliers of medical equipment and materials from many regions of Russia and foreign countries. It serves as a platform for professional exchange and sharing of experiences, showcasing the latest equipment and technologies.
On April 21, the official website of the Drug Evaluation Center (CDE) of the State Food and Drug Administration of the People’s Republic of China (CFDA) recently announced that Ganli Pharmaceutical’s Class 1 new drug, GZR102, has obtained the implied license for clinical trials in China and plans to develop and treat type 2 diabetes. According to the announcement of Ganli Pharmaceutical, GZR102 injection is a fixed ratio compound weekly preparation of basic insulin and glucagon like peptide-1 receptor agonist (GLP-1 RA) independently developed by Ganli Pharmaceutical. It is composed of GZR4 injection of under development ultra long acting insulin and GZR18 injection of ultra long acting GLP-1 RA bovaglutide in a fixed ratio. This is the first time that the product has been approved for clinical use in China. Both GZR4 and Bofanglutide have fully explored the drug dosage in the phase II clinical trial carried out in patients ...
On April 22, Hong Kong stock innovative pharmaceutical company Yunding Xinyao (01952. HK) announced that the company has obtained approval from the Hong Kong Stock Exchange to remove the “B” mark from its stock code. This marks another milestone in the company’s development history, as Yunding Xinyao has reached higher standards in terms of market value and revenue, and its commercialization capabilities have been further recognized. Since its listing on the Hong Kong Stock Exchange in October 2020, Yunding Xinyao has been focusing on the high-value “blue ocean” field under the “dual wheel drive” strategy of “authorized introduction” and “independent research and development”. At the same time, it is committed to developing innovative therapies that are pioneering or best in class. The company has formed a strong and synergistic platform in the fields of kidney disease, infectious diseases and autoimmune disease, and three commercial products have achieved rapid growth ...
Baike Bio (688276) held a performance briefing for 2024 and the first quarter of 2025 on April 21. Kong Wei, Vice Chairman of the Company, Jiang Chunlai, Director and General Manager, and Zhang Zhe, Secretary of the Board of Directors, interacted and communicated with investors on the specific situation of the operating results and financial indicators for 2024 and the first quarter of 2025. Baike Bio is a high-tech biopharmaceutical company specializing in the research and development, production and sales of human vaccines. The company currently has approved vaccine products such as varicella vaccine, nasal spray influenza vaccine, and shingles vaccine. Among them, the market share of varicella vaccine has been in the leading position for many years; the nasal spray influenza vaccine is a project of the World Health Organization (WHO) Global Influenza Action Plan (GAP), and is the only influenza live attenuated vaccine in China that is administered ...
On the evening of April 20, Zejing Pharmaceutical announced that the combination of ZG006 for injection and PD-1/PD-L1 immune checkpoint inhibitors has obtained the approval notice for drug clinical trials. The announcement shows that the company recently received the “Drug Clinical Trial Approval Notice” approved and issued by the National Medical Products Administration, and the clinical trial of ZG006 for injection combined with PD-1/PD-L1 immune checkpoint inhibitors for small cell lung cancer has been approved. The announcement shows that ZG006 for injection is a trispecific antibody drug developed by the company and its subsidiary Gensun Biopharma Inc. through its bi-/multi-specific antibody research and development platform. The drug has obtained clinical trial approval from both the U.S. FDA and China’s NMPA, and has been granted orphan drug status by the U.S. FDA. https://finance.eastmoney.com/a/202504213382407847.html
Recently, Biogen and Eisai jointly announced that the European Commission has officially approved their anti-amyloid β antibody drug Lecanemab for marketing for the treatment of mild cognitive impairment and mild dementia caused by Alzheimer’s disease (AD) in adult patients. This indication is limited to apolipoprotein Eε4 (ApoEε4) non-carriers or heterozygotes, and patients must be diagnosed with evidence of amyloid pathology. Back in July 2024, the European Medicines Agency gave a “not recommended” opinion on Lecanemab’s marketing application due to its benefit-risk ratio. After the research and development team supplemented additional data and the regulatory agency re-evaluated it, the drug was finally approved and became the first therapeutic drug in the EU for the potential cause of Alzheimer’s disease. The road to counterattack Lecanemab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that can selectively neutralize and remove soluble toxic Aβ aggregates that cause AD neuropathy, thereby positively affecting the AD ...
Recently, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that the NDA for Zurletrectinib (R&D code ICP-723), a Class 1 anti-tumor new drug independently developed by Innovent Biologics, has been accepted. The drug is a second-generation pan-TRK inhibitor, intended for the treatment of adult and adolescent patients (12 years old ≤ age < 18 years old) with advanced solid tumors carrying NTRK fusion genes, marking an important progress in China’s “unlimited cancer” targeted therapy field. Zolotinib is a new generation of pan-TRK inhibitor. Its core advantage lies in its ability to effectively solve the drug resistance problem of the first-generation TRK inhibitors (such as larotrectinib and entrectinib). According to the key registration Phase II clinical trial data disclosed in InnoCare Pharma’s 2024 annual report, the drug showed excellent efficacy in patients with NTRK fusion-positive advanced solid tumors, with an overall ...
Drugdu.com expert’s response: When Chinese traditional and Western medicines venture overseas, there are multiple aspects requiring attention, encompassing regulatory compliance, market access, intellectual property protection, and cultural difference management. Below is a detailed analysis: I. Regulatory and Compliance Aspects Target Market Regulations: It is essential to gain an in-depth understanding of the drug regulatory regulations in the target country or region, including requirements for registration, approval, clinical trials, and Good Manufacturing Practice (GMP) for production quality management. For example, the U.S. FDA mandates rigorous clinical trials before a drug can be marketed, while the EU EMA emphasizes compliance with GMP standards in the production process. Different countries have specific requirements for drug ingredients, labels, and instructions, necessitating compliance with local regulations. International Certifications and Standards: Obtaining international certifications (such as WHO prequalification, PIC/S GMP) can enhance product credibility and facilitate market access. Adhering to international quality standards (such as ISO, ICH guidelines) ensures product ...
Huadong Medicine (000963) issued an announcement that the company held an annual performance exchange meeting on April 18, 2025. The company said that it is actively preparing for the listing of Ailahe® and will actively participate in medical insurance negotiations to strive to enter medical insurance as soon as possible. Bailing Capsules were successfully selected in the national Chinese patent medicine alliance centralized procurement renewal at the end of last year. The winning price adjustment was relatively small. While ensuring the coverage of the core market, it also laid the foundation for subsequent grassroots penetration. The oral small molecule GLP-1 receptor agonist HDM1002 study achieved the preset test goals, has a good weight loss effect, and has good safety and tolerability. The first subject has been enrolled in the Phase III clinical study of weight management indications. The company’s semaglutide injection diabetes indication has been submitted for listing in March ...
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