media – Page 25 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Subsidiary Receives Clinical Trial Approval for Daratumumab Injection

China Securities Intelligent Financial News — CSPC NovaWise (300765.SZ) announced on the evening of December 23 that its majority-owned subsidiary, CSPC Megalith Biopharmaceutical Co., Ltd., recently received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration (NMPA) for its Daratumumab Injection. The drug will commence domestic clinical trials in the near future. According to the announcement, the injection is a recombinant all-human IgG1 monoclonal antibody targeting ADP-ribosyl cyclase (CD38). As a biosimilar to the originator drug DARZALEX®, it was filed under Category 3.3 for therapeutic biological products and is indicated for the treatment of adult patients with multiple myeloma. The development of this product follows the guiding principles for biosimilar research. Results from pharmaceutical and non-clinical studies demonstrate that the product is highly similar to the reference originator drug in terms of quality, safety, and efficacy, supporting the progression to subsequent clinical studies. Public records show ...
- Source: drugdu
- 73
- December 24, 2025
Walvax Bio’s subsidiary’s HPV vaccine selected for national centralized procurement

On December 23, Walvax Bio(300142) issued an announcement stating that its subsidiary participated in the National Immunization Program’s centralized procurement project for vaccines and successfully entered the shortlist. The announcement shows that Yuxi Zerun Biotechnology Co., Ltd.’s bivalent human papillomavirus vaccine (Pichia pastoris) was shortlisted for the project, with a shortlisted unit price of 27.5 yuan. This vaccine is primarily used to prevent diseases caused by high-risk HPV types 16 and 18, including cervical cancer. It was launched in China in 2022 and received prequalification from the World Health Organization in August 2024. This inclusion in the list will help expand the company’s sales of its bivalent HPV vaccine, increase market coverage, promote the market development of related products, and enhance brand influence. However, the announcement also pointed out that since only two companies were shortlisted, further negotiations with various provinces are needed, and the implementation period for vaccination is relatively ...
- Source: drugdu
- 77
- December 24, 2025
Jacobio secured the largest licensing deal for a clinical-stage small molecule anticancer drug, yet its stock price plummeted by over 13%. The chairman responded

“US$2.015 billion is, according to our statistics, the largest overseas licensing collaboration for small molecule anticancer drugs in the clinical stage in China.” On the morning of December 22, Jacobio (HK01167) held an online communication meeting regarding its newly announced business development (BD) efforts surrounding the pan-KRAS inhibitor JAB-23E73. Simultaneously, the company’s stock price fell by over 10%, closing down 13.58%. Both the transaction amount and AstraZeneca’s position in the oncology drug field have generated considerable excitement among investors who saw the news of the collaboration the night before. Moreover, this is Jacobio’s first business development (BD) deal announced this year. Was the secondary market’s reaction unexpected? At the communication meeting, Wang Yinxiang, Chairman of Jacobio, responded to this question from a reporter from the Daily Economic News. He said that as a biotech company, Jacobio pays attention to the secondary market, but it cannot be “led by the crowd” ...
- Source: drugdu
- 66
- December 24, 2025
Quanxin Biotech Reaches Licensing Agreement for QX027N, Targeting Asthma and Atopic Dermatitis

On December 22, Quanxin Biotech (02509) issued an announcement stating that it has entered into a licensing and collaboration agreement with LE2025 Therapeutics AG, a subsidiary of Windward Bio Group AG, authorizing it to exclusively develop and commercialize QX027N globally (excluding Mainland China, Taiwan, Hong Kong SAR and Macau SAR). In return, the company will be entitled to receive payments of up to $700 million, including upfront payments, equity in Windward Bio, development and commercial milestone payments, and tiered royalties based on net sales of QX027N in licensed territories. QX027N is a long-acting anti-TSLPxIL-13 bispecific antibody independently developed by the company. It successfully initiated a Phase I clinical trial on December 12, 2025, and completed the enrollment of the first subject. This antibody is intended for the treatment of asthma and atopic dermatitis and has received implied approval for clinical trials from the Center for Drug Evaluation of the National ...
- Source: drugdu
- 61
- December 24, 2025
【EXPERT Q&A】What are the requirements for the registration information of domestic active medical device products?

Drugdu.com expert’s response: The registration materials for domestically manufactured active medical device products need to meet various requirements, as detailed below: I. Basic Document Requirements Table of Contents: It should include all main and sub-headings, indicate the page numbers for each content in the table, and clarify applicability (e.g., whether the CR table of contents is applicable). Glossary of Terms and Abbreviations: Define terms or abbreviations that require clarification based on the actual situation of the registration application materials. Application Form: Fill out and upload the application form with a unified approval code exported from the application system (including the power of attorney), in accordance with the form-filling requirements. Product List: List the model numbers, specifications, structures and components, and accessories of the proposed products in tabular form, along with the identification (such as model or part numbers, unique device identifiers, etc.) and descriptive explanations (such as dimensions, materials, etc.) ...
- Source: drugdu
- 99
- December 24, 2025
With the Most Favored Nation (MFN) drug price negotiations concluded, what are the gains and losses for both sides?

After numerous meetings with pharmaceutical industry executives this year, the Trump administration’s Most Favored Nation (MFN) drug pricing strategy was finally implemented on December 19. That day, the US government announced drug pricing agreements with nine major multinational pharmaceutical companies, including Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech, Gilead Sciences, GlaxoSmithKline, Merck, Novartis, and Sanofi . These agreements cover a range of aspects, including Medicaid price reductions, internationally aligned pricing for new drugs, and the TrumpRx direct sales channel. Just months ago, Trump sent formal letters to 17 large multinational pharmaceutical companies, demanding that they lower drug prices in the United States and bring the cost of medicines paid by American patients back to the level of other high-income countries. This was seen as a sign that the United States was pushing for the launch of the Most Favored Nation (MFN) drug pricing system, and now, the signing of nine companies ...
- Source: drugdu
- 132
- December 23, 2025
49.3 billion! China’s top-selling innovative drug emerges

According to data from Yaozhi, from 2016 to the first half of 2025, among the domestic public medical institutions’ innovative drug sales rankings (calculated by brand sales), Huizhi’s atorvastatin calcium tablets have accumulated sales of RMB 49.27 billion , ranking first in China’s new drug market for nearly ten years, becoming a veritable “sales champion”. 01 “The Logic of the King” atorvastatin calcium tablets have maintained an unshakeable leading position in the top 10 list of new drug sales in domestic public medical institutions . Its cumulative sales of 49.27 billion yuan exceed those of the second-ranked budesonide inhalation suspension (38.245 billion yuan) by a full 11 billion yuan . Based on the total sales of the top 10, atorvastatin calcium tablets account for nearly 15% of the market share, demonstrating its significant market penetration and influence. Looking at the annual sales trend, 2016 to 2019 was its golden growth ...
- Source: drugdu
- 150
- December 23, 2025
Subsidiary’s Delafloxacin Meglumine for Injection Obtains Marketing Authorization

Aosaikang Pharmaceutical announced on December 22 that its subsidiary, Jiangsu Aosaikang Pharmaceutical Co., Ltd., has received the Drug Registration Certificate for Delafloxacin Meglumine for Injection approved and issued by the National Medical Products Administration (NMPA). Registered as a Class 3 chemical drug in injection dosage form with a specification of 0.3g (calculated as C18H12ClF3N4O4cap C sub 18 cap H sub 12 cap C l cap F sub 3 cap N sub 4 cap O sub 4𝐶18𝐻12𝐶𝑙𝐹3𝑁4𝑂4), the drug is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). As a novel broad-spectrum antibiotic, Delafloxacin demonstrates extensive and potent antibacterial activity against Gram-positive (G+cap G raised to the positive power𝐺+) bacteria, Gram-negative (G−cap G raised to the negative power𝐺−) bacteria, and anaerobic bacteria. Compared to other fluoroquinolone antibiotics, Delafloxacin possesses unique anionic properties, which enhance its antibacterial activity in acidic environments. Its ...
- Source: drugdu
- 76
- December 23, 2025
Self-developed Anti-cancer Drug HS387 Tablets Receive US Clinical Approval, Advancing Domestic and International Trials on Dual Tracks

CSI Smart Finance News — Hisun Pharmaceutical (600267.SH) announced on the evening of December 22 that the company has received notification from the U.S. Food and Drug Administration (FDA) that the Investigational New Drug (IND) application for its self-developed HS387 tablets has been approved. The company is now authorized to conduct clinical trials in the United States. The drug is intended for the treatment of advanced solid tumors, including high-grade serous ovarian cancer and non-small cell lung cancer (NSCLC). According to the announcement, HS387 is a selective KIF18A inhibitor. It previously received a “Drug Clinical Trial Approval Notice” from China’s National Medical Products Administration (NMPA), a milestone the company disclosed on July 2, 2025. In November 2025, the company submitted the IND application to the U.S. FDA and recently obtained approval. To date, while several KIF18A inhibitors have entered the clinical development stage globally, no such drugs have yet been ...
- Source: drugdu
- 78
- December 23, 2025
Warner Pharmaceuticals obtains drug registration certificate for isoproterenol hydrochloride injection

On December 22, Warner Pharmaceuticals(688799) issued an announcement stating that the company recently received the “Drug Registration Certificate” for isoproterenol hydrochloride injection issued by the National Medical Products Administration. This drug is an injectable preparation, available in 1ml:0.2mg and 5ml:1mg formulations. It is classified as a Class 3 chemical drug, and the approval conclusion indicates that it meets the relevant requirements for drug registration. Isoproterenol hydrochloride injection is primarily used to treat cardiogenic or septic shock, complete atrioventricular block, and cardiac arrest. Obtaining the drug registration certificate will further enrich the company’s formulation product portfolio and optimize its product structure. Although it will not have a significant impact on the company’s performance in the short term, future sales may still be affected by various factors such as policy changes, market demand, and competition from similar drugs, and there is a certain degree of uncertainty. In the first three quarters of ...
- Source: drugdu
- 74
- December 23, 2025

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