Recently, CanSinoBio’s 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197, TT vector) (hereinafter referred to as “PCV13i”) has obtained the summary report of the Phase III clinical trial. The report shows that the vaccine has good safety and immunogenicity, and the clinical study has reached the predefined clinical endpoints in the target population. CanSinoBio’s PCV13i adopts the covalent combination of polysaccharide antigen and protein carrier. After the polysaccharide antigen connects to the carrier protein, the polysaccharide can be transformed into T-cell-dependent antigen, which not only induces high specific antibody levels in infants and young children under the age of 2 years, but also generates memory B-cells and produces immune memory. At the same time, the company adopts dual-carrier technology, which can reduce the immunosuppression on immunogenicity caused by co-injection with other vaccines. In terms of production process, CanSinoBio adopts a safer production process, and the fermentation medium adopts medium of no animal ...
Recently, BIOKANGTAI’s wholly-owned subsidiary, Beijing Minhai Biotechnology, has signed a sales contract with its Indonesian partner, in which a detailed agreement was made on the quantity, unit price, total amount of the order, and shipment date of the world’s first dual-carrier 13-valent pneumococcal conjugate vaccine developed and produced by BIOKANGTAI to be exported to Indonesia. In October 2023, Minhai Biotech obtained the Marketing License for 13-valent Pneumococcal Polysaccharide Conjugate Vaccine issued by the Indonesian Food and Drug Administration, marking that the vaccine has the basic conditions for sale in the local market in Indonesia. The signing of this contract indicates that after years of market expansion, Kangtai’s 13-valent pneumococcal vaccine has formally opened for overseas sales, and as the relevant work continues to progress, this variety will bring new growth points for the company’s 2024 annual results. Dr. Lucia Rizka Andalusia, Acting Head of Indonesia’s Food and Drug Regulatory Agency ...
Drugdu.com expert’s response: Exporting pharmaceuticals to Canada requires adherence to specific processes and regulations. Here are the key steps for exporting pharmaceuticals to Canada: Understanding Canadian Regulations: Before exporting, familiarize yourself with the pharmaceutical regulations and regulatory requirements of Canada. Health Canada is the regulatory authority responsible for formulating and enforcing policies on drug imports. Familiarity with these regulations is essential to ensure that the exported pharmaceuticals comply with Canadian standards. Registration and Approval: Pharmaceuticals must be registered and approved by Health Canada before export. Depending on the type of drug, different application forms and materials may be required. Specific requirements can be found on Health Canada’s official website: https://www.canada.ca/en/health-canada.html Quality Management in Drug Production: Ensure that exported pharmaceuticals meet Canadian Good Manufacturing Practices (GMP). Exporting companies should regularly conduct internal audits to ensure compliance with GMP standards. Product Labeling and Instructions: Pharmaceutical labels and instructions must be prepared according ...
Recently, Hengrui Pharmaceuticals’ subsidiary Chengdu Shengdi Pharmaceuticals Co., Ltd. has received notification from the U.S. Food and Drug Administration (FDA) that the company’s abbreviated new drug application (ANDA, i.e., U.S. generic application) for the filing of tacrolimus extended-release capsule has been approved for production and marketing in the U.S. market. The product is indicated for use in combination with other immunosuppressive agents for the prevention of graft rejection following kidney transplantation in adults. The Company’s tacrolimus extended-release capsule is the first generic of this product approved for marketing by the U.S. FDA, and is also the first generic product approved for marketing in China. Tacrolimus is the core basic immunosuppressant after transplantation, which belongs to calmodulin neural phosphatase inhibitor (CNI), and its mechanism of action is to inhibit the expression and/or production of various cytokines, such as IL-1β, IL-2, IFN-γ, TNF-α, etc., by inhibiting the activity of calmodulin phosphatase, and ...
Recently, Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as “Gan & Lee”) received the registration approval for Menthol Insulin Injection (Cassette Vial) (Lot No. II-87550/2023) from the National Agency for Medicines and Technology for Health (Agencia Estatal de Medicamentos y Tecnologías en Salud, AGEMED) of Bolivia. Insulin Injection (Cassette Vial) (Lot No.: II-87550/2023). The relevant information is announced as follows: I. Basic information of the drug 1、Drug name: ASPARPEN 2、Generic Name of Drug: Mentholatum Insulin Injection 3、Indications: Diabetes mellitus 4、Dosage form: injection 5、Specifications: 3ml: 100U/ml (cassette bottle) 6、Batch No.: Ⅱ-87550/2023 7、Applicant: Gan & Lee Pharmaceutical Co. II. Other relevant information of the drug Mentholated insulin injection is a kind of rapid-acting insulin analog, which takes effect within 10~20 minutes after subcutaneous injection, the maximum action time is 1~3 hours after injection, and the duration of action is 3~5 hours, which can effectively control postprandial blood glucose. Mentholated insulin ...
(“AOSAIKANG”) has completed the registration clinical phase III study of ASKB589, a bio-innovative drug independently developed by AskGene Limited (“AskGene”), for the treatment of first-line advanced gastric cancer. ASKB589, a bio-innovation drug independently developed by AskGene Limited (“AskGene”), for the treatment of first-line advanced gastric cancer, has been administered to the first patient in China in the Phase III registration study: I. About the Registrational Clinical Phase III Study of ASKB589 The study is a multicenter, randomized, double-blind, standard treatment-controlled, efficacy-designed Phase III clinical study, which is planned to enroll 780 first-line gastric cancer patients in China, with the aim of evaluating the efficacy and efficacy of ASKB589 Injection or placebo in combination with CAPOX (oxaliplatin and capecitabine) and PD-1 inhibitor in the first-line treatment of CLDN18.2-positive unresectable locally advanced, recurrent or metastatic gastric and esophageal cancers, and to assess the efficacy and efficacy of the study. efficacy and safety ...
January 25, 2024, Nanjing, Shanghai, China, and San Jose, California, USA – IASO Bio, a biopharmaceutical company dedicated to the development, production and sales of innovative cell-based drugs, announced the National Medical Products Administration (NMPA) Review Center (CDE) has officially approved its fully human BCMA-targeted chimeric antigen receptor autologous T cell injection (Equecabtagene Autoleucel Injection, R&D code: CT103A) for the new expanded indication of refractory generalized myasthenia gravis (Myasthenia gravis, MG). ) clinical trial application (IND) (acceptance number: CXSL2300759). Equecabtagene Autoleucel Injection (trade name: Equecabtagene Autoleucel®) has been approved for marketing by the State Food and Drug Administration on June 30, 2023, for the treatment of relapsed and refractory multiple myeloma. The approval of this IND for myasthenia gravis further expands This is the second autoimmune indication approved for IND after Neuromyelitis Optica Spectrum Disease (NMOSD). IASO Bio is the first company in China to use CAR-T products for autoimmune ...
Shenzhen Biokangtai Pharmaceutical Co., Ltd. (hereinafter referred to as “BIOKANGTAI”), a wholly-owned subsidiary of BIOKANGTAI (hereinafter referred to as “the Company”), has recently received a notification of acceptance from the State Drug Administration, agreeing to accept the application for clinical trial of 20-valent Pneumococcal Sugar Conjugate Vaccine (hereinafter referred to as “20-valent Pneumococcal Conjugate Vaccine”) developed by BIOKANGTAI. (hereinafter referred to as “Minhai Biotechnology”), a wholly-owned subsidiary of the Company, has recently received a notification of acceptance issued by the State Drug Administration, agreeing to accept the application for clinical trial of the 20-valent Pneumococcal Polysaccharide Conjugate Vaccine developed by Minhai Biotechnology: I. Main contents of the acceptance notice Product Name: 20-valent pneumococcal polysaccharide conjugate vaccine Application: domestic production of drugs registered for clinical trials Applicant: Beijing Minhai Biotechnology Co. Ltd. Acceptance No.: CXSL2400053 According to the “People’s Republic of China Administrative License Law”, Article 32 of the provisions of ...
INNOCARE Pharmaceuticals Limited (the “Company” or “INNOCARE”) is currently in the clinical phase of registration of its innovative drug zurletrectinib (ICP-723). zurletrectinib (ICP-723) has shown favorable safety and efficacy in adult and adolescent (12 to 18 years old) patients. zurletrectinib (ICP-723) has demonstrated a favorable safety and efficacy profile in adults and adolescents (12 to 18 years of age), and has recently completed the first case of administration in a pediatric patient (2 to 12 years of age), initiating the first clinical study in a pediatric patient. The main information is announced as follows: I. Introduction of ICP-723 Zurletrectinib (ICP-723) is INNOCARE’s proprietary second-generation pan TRK small molecule inhibitor for the treatment of patients with advanced or metastatic solid tumors harboring NTRK fusion genes who have not received TRK inhibitor therapy and who are resistant to first-generation TRK inhibitors. Zurletrectinib (ICP-723) can effectively inhibit not only TRKA, TRKB, and TRKC ...
Xi’an Beilin Pharmaceutical Co., Ltd. (西安碑林药业股份有限公司, Xi’an Beilin), a subsidiary of Grand Pharmaceutical Group Limited (Grand Pharma, 0512.HK), recently entered into the second acquisition agreement with Chongqing Duoputai Pharmaceutical Co., Ltd. (重庆多普泰制药股份有限公司). Xi’an Beilin is to acquire 63% equity interest in Chongqing Duoputai Pharmaceutical Technology Co., Ltd. (重庆多普泰医药科技有限公司, Duoputai Pharmaceutical Technology) at a consideration of RMB442.26 million following the fulfillment of the relevant conditions. With the completion of the acquisition agreement, Xi’an Beilin will hold a 90% equity interest in Duoputai Pharmaceutical Technology, which will become a subsidiary of Grand Pharma to further consolidate the Group’s market position in the field of cerebro-cardiovascular disease treatment. https://www.grandpharm.com/en/news/grand-pharma-strategically-controls-duoputai-pharmaceutical-technology-strengthening-the-strategic-plan-in-field-of-cerebro-cardiovascular-disease-treatment
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