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 ...
On April 20, the company announced that HRS-1167 tablets obtained the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration and will conduct clinical trials in the near future. HRS-1167 tablets are highly selective, highly active, and orally available PARP1 small molecule inhibitors independently developed by the company with intellectual property rights. They belong to the second generation of PARP inhibitors. Compared with the first generation of PARP inhibitors, HRS-1167 has higher selectivity and stronger affinity for PARP1. HRS-1167 is currently in the early clinical development stage and has the potential to be used as a monotherapy and combination therapy to treat more patients, including tumor patients who were previously unable to use PARP inhibitors. Upon inquiry, no similar products have been approved for marketing at home and abroad. As of now, the R&D expenses of HRS-1167 tablets related projects have accumulated to approximately RMB 72.11 million. ...
On April 18, Watson Bio (300142) issued an announcement that the 20-valent pneumococcal polysaccharide conjugate vaccine jointly applied for clinical trials by the company and its subsidiaries has obtained the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration, with the notice number: 2025LP01099. The clinical trial of this vaccine will target children aged 2 months (minimum 6 weeks old) to 5 years old to prevent infectious diseases caused by the 20 pneumococcal serotypes contained in this product. This vaccine is an iterative upgrade based on the company’s already marketed 13-valent pneumococcal polysaccharide conjugate vaccine, with 7 new serotypes added. At present, only Pfizer in the United States has launched a 20-valent pneumococcal polysaccharide conjugate vaccine in the world, and there are no related products in China. In 2024, Watson Bio achieved revenue of 2.821 billion yuan and net profit attributable to shareholders of the parent company ...
In 2024, Jindik achieved operating income of 80.8027 million yuan, a year-on-year decrease of 39.96%, and lost money for the second consecutive year. At present, Jindik has only one product on the market, namely the quadrivalent influenza virus split vaccine. In 2024, the price of this product was reduced by 30%, directly falling below 100 yuan. Profitability was weakened and sales expenses accounted for too high a proportion, both dragging down the company’s performance. In order to get rid of dependence on a single product, Jindik has increased its R&D investment. At present, the rabies vaccine product has completed Phase III clinical trials and is in the process of product registration and declaration. Flu vaccine followed the trend of price reduction, and sales volume and price fell in one year In 2024, Jindik not only failed to reverse the loss, but fell deeper and deeper. On April 17, the company ...
Organiser:Reed Sinopharm Exhibitions, APHM Time:June 9-11, 2025 address:50088 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Jalan Pinang, Kuala Lumpur City Centre Exhibition hall:Kuala Lumpur Convention Centre, Malaysia Product range: Medical and Hospital Equipment & Machinery: Diagnostic equipment and supplies, dental products, consumables, emergency equipment, disposable items, hospital information systems, medical staff uniforms, nursing supplies, etc. Electronic Medical Equipment: Instruments, blood pressure monitors, laser equipment, surgical tools, scanning devices, etc. Medical Laboratories: Analytical instruments, microbiology, analysis, biochemical equipment, etc. Pharmaceutical Machinery: Bioengineering, finished pharmaceuticals, pharmaceutical raw materials, pharmaceutical processing, pharmaceutical packaging, pharmaceutical services, analytical and testing instruments, pharmaceutical laboratory equipment, etc. Rehabilitation and Home Care: Assistive and physical devices, rehabilitation equipment, orthopedic devices, sports facilities, wheelchairs, fitness equipment Aesthetic and Medical Beauty-Related Products: Biotechnology products, diagnostic and testing instruments, beauty products, aesthetic equipment, dressings and consumables, anti-aging medical products, related technologies and services, etc. About APHM CMEF Malaysia: The APHM ...
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