On April 3, Jianyou Shares (603707) issued an announcement that the company recently received an approval letter for liraglutide injection, 18 mg/3 mL (6 mg/mL), (ANDA No.: 218115) issued by the US Food and Drug Administration. The drug has a specification of 18mg/3mL (6mg/mL) and can be used as an adjunct to diet and exercise to improve blood sugar control in adults and children aged 10 years and above with type 2 diabetes, while reducing the risk of major adverse cardiovascular events in adult patients with type 2 diabetes with cardiovascular disease. So far, the company has invested approximately RMB 57.37 million in the research and development project of liraglutide injection. The newly approved product will be available in the United States in the near future and is expected to have a positive impact on the company’s operating performance. This event has become an important window for observing its global ...
The measles epidemic in the United States is attracting great attention from the health department. The latest report from the Centers for Disease Control and Prevention (CDC) of the United States stated that as of April 3, the total number of measles cases in the United States has reached 607, more than double the 285 cases in the same period last year. The number of cases increases by more than 100 cases every week. According to the report of the Texas Department of State Health Services on April 4, the total number of measles cases in the state has now reached 481, an increase of 59 cases in three days, an increase of 14%; the number of hospitalizations has increased from 42 to 56. Sapna Singh, chief medical officer of Texas Children’s Hospital, said that judging from the current official reported data, measles cases are far from reaching the goal ...
Masulaxavir Tablets——China’s first independently developed anti-influenza drug targeting PA On March 27, according to the official website of NMPA: Masulaxavir Tablets (trade name: Isuda), a Class 1 innovative drug applied for by Jiangxi Kerui Pharmaceutical Co., Ltd., a subsidiary of Qingfeng Pharmaceutical, was approved for marketing. It is used to treat previously healthy adolescents and adults aged 12 years and above with simple influenza A and B, excluding patients at high risk of influenza-related complications. In recent years, the incidence of influenza has continued to rise internationally , driving a surge in demand for anti-influenza drugs. According to Yaozhi data, the market size of anti-influenza drugs in China will approach 20 billion yuan in 2023. In such a huge market context, the approval of Masulaxavir Tablets is undoubtedly a blockbuster. Masulaxavir tablets are an innovative anti-influenza virus drug jointly developed by Qingfeng Pharmaceutical and Ginkgo Biloba Pharmaceuticals. It is a ...
Drugdu.com expert’s response: Depending on the target market, exporting cosmetic ingredients requires compliance with China’s export qualifications, import regulations of the target country, and international certification standards. Below are the specific requirements: I. China’s Export Qualification Requirements 1. Enterprise Qualification Registration Customs Registration: Complete the Registration for Foreign Trade Operators and obtain the registration certificate. Business License: The scope of business must include “import/export of goods” or “import/export of technology,” and a copy of the license must be provided. Tax Compliance: Submit the tax registration certificate (if the three certificates have been integrated, it is included in the business license). Foreign Exchange and Tax Rebates: Complete the procedures for opening a foreign exchange account and registering for export tax rebates (if applicable). 2. Product Compliance Documents Material Safety Data Sheet (MSDS): Outline the physical and chemical properties, toxicity, first aid measures, etc., of the ingredients. Component Analysis Report: Issued by a qualified ...
Drugdu.com expert’s response: The implementation of the Measures for the Protection and Management of Drug Trial Data has significant dual advantages and disadvantages, requiring comprehensive assessment from multiple dimensions including institutional innovation, market competition, and patient needs. The following analysis is based on specific cases and policy logic: I. Core Benefits: Driving Innovation and Regulating the Market Innovation Incentives and Long-term Investment Guarantee Market Exclusivity Period Forms a Return Loop: Innovative drug companies need to invest decades of time and hundreds of millions of dollars in clinical trials. Data protection ensures they can recover costs and obtain reasonable profits through a market exclusivity period of 6-12 years (e.g., Keppra was approved for marketing in over 90 countries through protection), enabling continuous investment in the next generation of drug development. First Generic Drug Incentives Fill Gaps: Providing a 3-year data protection period for the first generic drug (e.g., the first generic ...
According to foreign media reports, on April 1, global orthopedic giant Stryker announced that it had completed the sale of its US spinal implant business to Viscogliosi Brothers, LLC, a family investment company focusing on the neuromusculoskeletal field. It is worth noting that the transaction led to the establishment of a new company called VB Spine, LLC (VB Spine), which also marked the official implementation of Stryker’s business restructuring plan announced in January this year. Previously, Stryker stated that in addition to the US market, its international spinal implant business will also be gradually divested. From Stryker’s 2024 financial report, it can be seen that its spinal implant business can no longer help the company’s revenue. The financial report shows that in 2024, its spinal implant business revenue was US$707 million (a year-on-year decrease of 0.7%), of which the US spinal implant business decreased by 2.1% year-on-year. The specific financial ...
Recently, the official website of the National Medical Products Administration (NMPA) showed that Yangtze River Pharmaceutical’s Aguratimod tablets, which were applied for as a generic 4 drug, were officially approved for marketing, becoming the second company in China to have its generic drug approved and pass the consistency evaluation. This progress not only marks a further breakthrough for Yangtze River Pharmaceutical in the field of anti-rheumatic diseases, but also provides more treatment options for domestic patients with rheumatoid arthritis. Eguratimod tablets are a new type of disease-modifying antirheumatic drug (DMARDs) that has both anti-inflammatory and immunomodulatory mechanisms. It can inhibit the production of inflammatory factors such as IL-6 and TNF-α, while delaying bone erosion and promoting bone formation. Clinical data show that it can be effective in 2-4 weeks when used in combination with methotrexate, with a patient remission rate of over 60%, and significantly lower liver toxicity and infection ...
On the evening of April 1, 2025, Huadong Medicine Co., Ltd. (stock code: 000963.SZ, hereinafter referred to as “Huadong Medicine”) issued an announcement stating that the company’s wholly-owned subsidiary Hangzhou Sino-US Huadong Pharmaceutical Jiangdong Co., Ltd. (hereinafter referred to as “Jiangdong Company”) received the “Acceptance Notice” issued by the National Medical Products Administration (NMPA), and the application for marketing authorization of semaglutide injection was accepted. The indication for this application is blood sugar control in adult patients with type 2 diabetes. In addition, the clinical trial application for the fluid re-management indication of semaglutide injection was approved by NMPA in September 2024, and the first subject was enrolled in the Phase III clinical trial in December 2024. Due to the excellent and popular hypoglycemic and weight loss effects of semaglutide, its biosimilars will face huge market opportunities when they are launched. Semaglutide becomes the “King of GLP-1 Drugs” and has ...
Despite fierce market competition, SiliDi Pharmaceuticals delivered a “cost reduction and efficiency improvement” report card in 2024: revenue declined but losses narrowed significantly, sales of its core product Envida grew by 15.9% in the second half of the year against the trend, and the mRNA tumor vaccine pipeline achieved key breakthroughs. How will this innovative pharmaceutical company make a comeback in the future? Sales of core products declined According to the financial report, in 2024, SiliDi achieved revenue of approximately RMB 446 million, a year-on-year decrease of 29.8%; gross profit was RMB 409 million, a year-on-year decrease of 30.2%. In addition, thanks to a significant reduction in R&D expenses and sales and marketing expenses (down 57.5% and 37.7% respectively), the full-year net loss narrowed to RMB 199 million, a year-on-year decrease of 64.6%. Subcutaneous injection of PD-L1 Envolimab (trade name: Envida) is the only commercialized product of SilDi, and the ...
On January 2nd, Xinda Biotechnology and Roche reached a global cooperation agreement to grant Roche the development, production, and commercialization rights of the new generation ADC drug IBI3009 targeting DLL3. The total transaction amount is up to $1.08 billion, including a down payment of $80 million and milestone payments. The drug has been administered to the first patient in phase I clinical trials for small cell lung cancer (SCLC) and is planned to be developed in combination with Roche PD-L1 inhibitor atezolizumab. On January 7th, Yingen Biotechnology awarded Avenzo Therapeutics the overseas rights to the EGFR/HER3 dual antibody ADC drug DB-1418, receiving a down payment of $50 million and a milestone payment of up to $1.15 billion; On January 13th, its HER2 ADC drug DB-1303 received a down payment of $25 million and a milestone payment of $42 million from Sansheng Pharmaceutical, accelerating its commercial layout in China. According to ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.