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Huahai Pharmaceutical’s Subsidiary Adalimumab Injection Drug Registration Application Accepted

Financial Associated Press, December 13 – Huahai Pharmaceutical (600521) released a notice regarding the acceptance of its subsidiary’s application for drug marketing authorization. The company’s wholly-owned subsidiary, Zhejiang Huahai Biotechnology Co., Ltd., has recently received the “Acceptance Notice” issued by the National Medical Products Administration for the application for the domestic production registration of adalimumab injection. This medication is primarily used to treat rheumatoid arthritis, ankylosing spondylitis, psoriasis, and other conditions, and is classified as a Class 3.3 therapeutic biological product. To date, the company has invested approximately 193 million yuan in research and development for this project. According to estimates from Frost & Sullivan, the sales revenue of adalimumab biosimilars in China is expected to grow from approximately 2.2 billion yuan in 2022 to approximately 4.851 billion yuan in 2023, with the market size projected to reach 11.5 billion yuan by 2030. This acceptance marks the entry of the ...
- Source: drugdu
- 89
- December 16, 2024
Jin Pharmaceutical’s Subsidiary Potassium Chloride Injection Obtains Consistency Evaluation for Generic Drugs

Jin Pharmaceutical (600488) announced that its subsidiary, Jin Pharma Peace (Tianjin) Pharmaceutical Co., Ltd., has recently received approval from the National Medical Products Administration (NMPA) for its potassium chloride injection, successfully passing the consistency evaluation for the quality and efficacy of generic drugs. This medication is classified as a category A product under the national medical insurance system and is primarily used to treat and prevent hypokalemia, making it suitable for patients who cannot take potassium supplements orally. As of now, Jin Pharma Peace has invested approximately 4.93 million yuan in research and development for the potassium chloride injection project. According to market data, the domestic sales revenue for potassium chloride injection was 612 million yuan in 2022 and 661 million yuan in 2023. With the successful completion of the consistency evaluation, the market competitiveness of this product is expected to improve, and medical institutions are likely to prioritize the ...
- Source: drugdu
- 74
- December 16, 2024
Roche clears a track with one click

MNC Roche took out a “machete”. In Roche’s 2024Q2 PPT presentation, there are 5 pipelines in the anti-infection pipeline echelon, 4 of which are Ruzotolimod (TLR7 agonist), Xalnesiran (small interfering RNA), PDL1 LNA and HBsAg monoclonal antibody, all of which are in Phase I and II clinical trials. When it comes to the presentation of 2024Q3, the situation has changed. Roche cut off the above 4 pipelines with the target indication of hepatitis B at one time. The company did not give a specific reason for the “clearance”. The most speculation in the market is that the clinical pipeline data is “unsatisfactory + Roche streamlines the pipeline to focus its energy and investment on core areas”. However, for Roche, the anti-infection sector has always been a relatively marginal module of the company. In the key drivers introduced by the company in 2024Q2 after 2025, the molecules of the anti-infection (hepatitis ...
- Source: drugdu
- 72
- December 16, 2024
【EXPERT Q&A】FDA small business application, what are the tips and guidelines?

Drugdu.com expert’s response: Ⅰ. FDA Small Business Application Guide Understanding the Definition and Benefits of FDA Small Business Definition of Small Business: A small business is defined as an applicant and its affiliates whose total gross annual sales or receipts for the most recent fiscal year do not exceed 100million(notlimitedtoU.S.businesses).Ifthetotalgrossannualsalesorreceiptsofasmallbusiness/affiliatedcompanydonotexceed30 million, it is eligible for a fee waiver for Premarket Approval (PMA) applications. Benefits: The FDA offers fee reductions for small businesses. For example, the small business fee for a 510(k) submission is 25% of the standard fee, which can save up to over $16,000 (the exact amount may vary by year). Preparing the Small Business Certification Application Application Form: The dedicated FDA application form (Form FDA 3602A MDUFA Foreign Small Business Certification Request) should be completed. The form should be opened using the latest version of Adobe Pro, and not domestic software such as WPS. Ⅱ. Application Process: Starting from ...
- Source: drugdu
- 121
- December 16, 2024
Xinlitai’s “Class 1 weight loss new drug” was approved for clinical trials in China

On December 11, according to the official website of CDE, Xinlitai’s Class 1 imported chemical drug DD01 injection obtained implicit approval for clinical trials and is intended to be used for weight management in obese adult patients or overweight patients with one or more weight-related risk factors (such as hypertension, type 2 diabetes or dyslipidemia). DD01 is a long-acting GLP-1R/GCGR dual agonist. In September 2021, Xinlitai introduced the drug from South Korea’s D&D Company for a total amount of no more than US$27 million. According to Xinlitai’s announcement, DD01 selectively activates GLP-1 receptors and GCGR receptors, excites downstream pathways, and produces biological effects such as lowering blood sugar, lowering body weight, lowering liver fat, lowering serum cholesterol, and improving liver function. Preclinical experimental studies have shown that compared with semaglutide, DD01 can not only achieve similar blood sugar lowering effects, but also has more obvious effects on improving fat metabolism ...
- Source: drugdu
- 91
- December 14, 2024
A world first! AstraZeneca “strikes a gold mine”

AstraZeneca recently announced that its PD-L1 monoclonal antibody Imfinzi has been approved by the FDA in the United States for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed after concurrent platinum chemotherapy and radiotherapy, becoming the world’s first and only immunotherapy for LS-SCLC. In the ADRIATIC Phase III clinical trial, the average overall survival (OS) of the Imfinzi group was 55.9 months, and that of the placebo group was 33.4 months, a full 22.5 months increase. This is a very groundbreaking progress, breaking the LS-SCLC treatment bottleneck of more than 30 years. AstraZeneca “dug up the gold mine”, and its lung cancer treatment map has been further expanded. Expanding the lung cancer drug map Before 2000, there were only three means of treating lung cancer: chemotherapy, radiotherapy and surgery, especially for patients with advanced lung cancer, who had limited options. It ...
- Source: drugdu
- 103
- December 14, 2024
Wholly-owned Subsidiary’s CS12088 Clinical Trial Application Accepted

According to a news report on December 10, ChipScreen Biotech announced that its wholly-owned subsidiary, Chengdu ChipScreen Pharmaceuticals Co., Ltd., recently received the Acceptance Notice for the clinical trial registration of domestically-produced drugs issued by the National Medical Products Administration (NMPA) Drug Review Center. The clinical trial application for CS12088 has been accepted by the NMPA Drug Review Center. CS12088 is classified as an HBV core assembly modulator, featuring significant antiviral activity, liver-targeting characteristics, and good safety and tolerability. This medication works by interfering with the assembly of the HBV core, blocking the packaging of the viral pre-genomic RNA into the core, which in turn inhibits the replication of HBV DNA and suppresses the production of mature viral particles. The company will actively advance this research and development project and will strictly comply with relevant regulations to timely fulfill its disclosure obligations regarding the subsequent progress of the project. https://finance.eastmoney.com/a/202412103264202237.html
- Source: drugdu
- 81
- December 14, 2024
“Hanquyou” Debuts in the U.S. with First Commercial Supply

Recently, Henlius announced the shipping of its independently developed and produced biosimilar trastuzumab, “Hanquyou,” from the company’s Songjiang base to the U.S. market. This marks the first commercial supply to North America and represents another significant breakthrough in the company’s global strategic layout. With this, Henlius’ commercial supply network has successfully expanded to regions including China, Southeast Asia, North America, Europe, the Middle East, and Latin America. The international market expansion and high-quality development of Henlius are supported by the comprehensive lifecycle services provided by the Songjiang District. Leveraging the Shanghai Biomedical Registration Guidance Service Station, the district has proactively engaged to provide guidance and dedicated tracking, assisting biopharmaceutical companies like Henlius in accelerating drug research and production, which in turn promotes the vigorous development of the strategic emerging industrial cluster in Songjiang’s biopharmaceutical sector. Henlius’s product portfolio covers areas such as oncology, autoimmune diseases, and ophthalmology, with six products ...
- Source: drugdu
- 79
- December 14, 2024
Pharmaceutical companies’ quotations are becoming more “rational”

The selection results of the highly anticipated tenth batch of national drug procurement have been announced. First Finance learned that 62 kinds of drugs were successfully purchased, all of which were out of patent, produced by many enterprises, and fully competitive, covering hypertension, diabetes, tumors, cardiovascular and cerebrovascular diseases, infections, mental diseases and other fields; A total of 385 products from 234 companies have obtained the qualification to be selected. According to the selection results released by Shanghai Sunshine Pharmaceutical Procurement Network, although the overall average decrease has not been announced, based on several super large varieties, the price per box (1 box of 100 tablets) of 0.63mg “Compound Alpha Ketonic Acid Tablets” produced by Beijing Fuyuan Pharmaceutical ranges from 149 yuan to 178.99 yuan, with a proposed selection price of 42.82 yuan, a decrease of over 71%; There is also a 10ml specification of “Doxorubicin Hydrochloride Liposome Injection” produced ...
- Source: drugdu
- 87
- December 14, 2024
The foundation of traditional Chinese medicine innovation lies in theoretical innovation

Traditional Chinese medicine is a treasure of Chinese civilization. The Third Plenary Session of the 20th Central Committee of the Communist Party of China explicitly mentioned the need to “improve the mechanism for inheriting, innovating, and developing traditional Chinese medicine.” For enterprises in the field of traditional Chinese medicine, how can they do a good job in the creative transformation and innovative development of traditional Chinese medicine? On December 11th, at the “New Ecology, New Future -2024 China Pharmaceutical and Health Industry Summit Forum” hosted by China Business News, focusing on the inheritance and innovation of traditional Chinese medicine, Wu Rui, the secretary of Shijiazhuang Yiling Pharmaceutical Co., Ltd. (hereinafter referred to as “Yiling Pharmaceutical”, 002603. SZ), stated that the foundation of traditional Chinese medicine innovation lies in theoretical innovation, which can drive subsequent prescription innovation and production process innovation in the research and development stage. Wu Rui introduced that ...
- Source: drugdu
- 79
- December 14, 2024

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