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【EXPERT Q&A】What are the advantages and disadvantages of the implementation of drug test data protection management measures?

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 ...
- Source: drugdu
- 25
- April 4, 2025
Orthopedic giant Stryker announced the completion of the sale of this business

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 ...
- Source: drugdu
- 27
- April 4, 2025
Yangtze River Pharmaceuticals enters the race for Elamod

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 ...
- Source: drugdu
- 27
- April 4, 2025
Huadong Medicine, a leader in diabetes, has its domestic application for semaglutide accepted

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 ...
- Source: drugdu
- 25
- April 4, 2025
Another mRNA company emerges

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 ...
- Source: drugdu
- 25
- April 4, 2025
6 domestic ADCs successfully go global

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 ...
- Source: drugdu
- 47
- April 3, 2025
Medical equipment giant begins layoffs and factory closures

Cardinal Health, a global medical device giant, recently announced a major decision to close its factory in Tullamore, County O’Farley, Ireland in the spring of 2026 and cease production of a product. This decision will result in approximately 315 employees losing their jobs. It is reported that the manufacturing operations of the factory will be relocated to Mexico and Costa Rica to better meet the needs of the company’s global business, manufacturing, and supply chain operations. Jiadeno announced this plan in September 2024 and stated that the first batch of layoffs will begin in March and April 2025, while the second batch of layoffs will take place in April and May 2026. 01. The final shutdown date is May 2026 The history of Tullamore factory can be traced back to 1982, when it was established by Sherwood Medical. Over time, the factory has undergone multiple changes of ownership. In 1998, ...
- Source: drugdu
- 44
- April 3, 2025
Pharmtech Ingredients

Organiser: ITE Group Time: November 25-28, 2025 Address: 65-66 km Moscow Ring Road, Krasnogorsk, Russia Exhibition hall: Crocus-Expo IEC Product range: Pharmaceutical Machinery: Formulation production equipment, pharmaceutical water systems, traditional medicine processing equipment, refrigeration units, etc. Packaging Equipment & Materials: Aluminum-plastic packaging machines, filling machines, tablet presses, labeling machines, coding machines, anti-counterfeit printing and packaging, barcode composite technology equipment, adhesive label printing machines, plastic packaging products, container forming/filling/sealing machines, cartoning machines, bagging machines, multi-functional bottling lines, glass packaging, and pharmaceutical packaging material production equipment. Lab Equipment & Analysis: Laboratory instruments, consumables, chemical reagents, biochemical/analytical instruments, biotech testing equipment, pharmaceutical QA/QC devices, food analysis tools, medical industry analyzers. Fluid Handling Systems: Sanitary pumps, valves, fluid engineering, pipelines and fittings, microfiltration/ultrafiltration systems. Cleanroom Technology: Clean air-conditioning systems, clean workstations/tables, sterilization equipment, anti-static clothing. Pharmaceutical Excipients: Packaging materials, excipients, and related production equipment. Biotechnology: Biotech products and applications, fermenters, vaccines and enzymes, bio-facility infrastructure. About ...
- Source: drugdu
- 31
- April 3, 2025
Cultivate “Innovation Skills” and Cultivate “Conscience Seedlings”

After 14 years of deep cultivation in the vaccine track, Aim Vaccine’s innovative achievements have gradually blossomed, and it has embarked on a small, beautiful, refined and specialized road of special vaccine research and development in the global market. In March this year, the company’s mRNA herpes zoster vaccine obtained clinical trial approval from the U.S. Food and Drug Administration (FDA); mRNA RSV (respiratory syncytial virus) vaccine was approved for clinical trials in the United States in February; by the end of 2024, the company’s two blockbuster single-product vaccines will iterate serum-free rabies vaccine and 13-valent pneumococcal conjugate vaccine, obtain corresponding production licenses, and submit a listing registration application. “For traditional products, ‘the last one standing will win’, and for high-end single products, ‘all will prosper together’. We firmly believe that focusing on the research and development of iterative vaccine series is the real growth engine in the future, which ...
- Source: drugdu
- 44
- April 3, 2025
Zhifei Biotech’s adjuvanted trivalent influenza vaccine has obtained clinical trial approval, which is expected to further enrich the company’s virus vaccine varieties

Zhifei Biotech announced on the evening of April 1 that the trivalent influenza virus split vaccine (ZFA02 adjuvant) (referred to as “adjuvanted trivalent influenza vaccine”) developed by its wholly-owned subsidiary Anhui Zhifei Longcom Biopharmaceutical Co., Ltd. has recently obtained the National Drug Administration’s drug clinical trial approval notice (notice number: 2025LP00953), agreeing to conduct clinical trials to prevent influenza caused by vaccine-related influenza viruses. The company stated that it will carry out relevant clinical trials as soon as possible according to the requirements of the clinical trial approval. It is understood that influenza is an acute respiratory infectious disease caused by influenza virus that can cause large-scale epidemics. It is highly contagious and can cause complications such as pneumonia, bronchitis, and myocarditis. It can also aggravate the basic diseases of high-risk groups such as the elderly and the weak. Vaccination against influenza is the most economical and effective measure to ...
- Source: drugdu
- 42
- April 3, 2025

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