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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
- 41
- 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
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- 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
- 39
- December 23, 2025
NonaBio and Porton Pharma Solutions have entered into a strategic collaboration to jointly promote the industrialization of innovative complex antibody therapies

On December 22, NonaBio, a company specializing in fully human antibody technology, and Porton Pharma Solutions, a CDMO company, officially entered into a deep strategic cooperation agreement. The two parties will focus on the full lifecycle R&D and production of novel antibody-based therapies, including bispecific and multi-antibody formulations. Through the synergy of “innovative technology platforms + industrialization capabilities,” they aim to address pain points in the industry such as difficult process development, high compliance requirements, significant cost challenges, and long translation cycles, accelerating the transition of innovative therapies from the laboratory to clinical practice and the market. In this collaboration, both parties will leverage their complementary strengths to form a joint development and management team, promoting the integrated development and full-process management of NonaBio’s related projects. They will achieve deep collaboration in key areas such as project management and quality systems, focusing on the entire lifecycle of complex antibody projects ...
- Source: drugdu
- 36
- December 23, 2025
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation to AMT-253, developed by PuZhong Discovery

On December 17, 2025, according to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), the key product AMT-253 (a MUC18-targeting ADC) developed by PuZhong Discovery has been included in the Breakthrough Therapy Designation list. The intended indication is for previously treated, unresectable locally advanced, recurrent, or metastatic melanoma. AMT-253 is the world’s first and only MUC18-targeting ADC to have entered clinical development, representing a potential first-in-class ADC therapy for melanoma. It is expected to achieve significant breakthroughs in both treatment mechanisms and paradigms for this indication. In the Australian Phase I and China Phase I/II trials of AMT-253, 36 chemotherapy-naïve melanoma patients were treated with AMT-253. As of September 8, 2025, the objective response rate (ORR) was 41.7%, the disease control rate (DCR) was 80.6%, and the median progression-free survival (mPFS) was 8.5 months. Clinical data suggest that AMT-253 demonstrates clinical ...
- Source: drugdu
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- December 23, 2025
Novel Vaccine Strategy Offers Protection Against Deadly Filovirus Infections

A team from the Scripps Research Institute, a top U.S. biomedical research institution, has transformed nanoparticles into viral “display boxes,” developing a novel vaccine strategy to protect against multiple deadly filovirus infections. In their latest study published in Nature Communications, the team reported that this new vaccine displays filovirus surface proteins on engineered self-assembling protein nanoparticles, enabling the immune system to more effectively recognize and respond to the virus. Experiments showed that it can induce a potent antibody response against multiple viruses, offering a new pathway for developing broader and more effective protective strategies. The filovirus family includes several highly pathogenic viruses, such as Ebola virus, Sudan virus, Bundibugyo virus, and Marburg virus. Although two Ebola vaccines have been approved, there is currently no vaccine capable of providing broad protection against the entire filovirus family. A key reason for their lethality is the structural instability of their surface proteins, which ...
- Source: drugdu
- 40
- December 23, 2025
Analytica

Organiser：CloserStill Media Ltd Time： March 24–27, 2026 Address：Messegelände, 81823 München Exhibition hall：Neue Messe München Product range: Analytical Sector: Analytical instruments, chromatography, spectrometers, microscopes, and optical image processing Life Sciences & Biotechnology: Bioanalytical methods, biochemical reagents, bioinformatics, biotechnology and laboratory techniques, pharmaceuticals, and diagnostics Measurement, Testing & Quality Control: Industrial quality control, material testing, material identification, pharmacological quality, and industrial quality assurance Laboratory Technology: Laboratory equipment and apparatus, laboratory database systems and document management, laboratory instruments, chemicals, and reagents About Analytica： The Analytica exhibition in Munich, Germany, is the world’s largest event in the field of analytical science. As a premier professional trade fair for analytical science, biotechnology, diagnostics, and laboratory technology, it has spanned nearly half a century since its inception in 1968. Professionals and enterprises from around the globe gather in Munich, Europe’s captivating city, for a week of reunion and achievement.
- Source: drugdu
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- December 23, 2025
Nxera seeks schizophrenia programme buyer after Boehringer snub

Japan-based Nxera Pharma is seeking buyers for its Phase II-ready schizophrenia programme after Boehringer Ingelheim decided not to exercise a licensing option. Boehringer Ingelheim, which held exclusive rights to license the neurological disorder portfolio of GPR52 agonists, did not provide further information to Nxera. Rights to the programme will now revert to the Japanese biotech. Nxera said it is now exploring strategic opportunities for the programme, including a licensing partnership with a major pharmaceutical or specialist neuroscience company in 2026. Despite the hitch, Nxera said there will be no financial impact. https://www.pharmaceutical-technology.com/news/nxera-seeks-schizophrenia-programme-buyer-after-boehringer-snub/
- Source: drugdu
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- December 22, 2025
First innovative traditional Chinese medicine for frequent tension headaches launched.

On December 21, Fang Sheng Pharmaceutical…A product launch and investor relations event for “Yangxue Qufeng Zhitong Granules” was held in Changsha. A representative from Fang Sheng Pharmaceutical stated that Yangxue Qufeng Zhitong Granules is China’s first Class 1.1 traditional Chinese medicine specifically formulated for frequent tension-type headaches.Innovative drugsIn June 2025, it obtained the Drug Registration Certificate issued by the National Medical Products Administration. This new drug is derived from the classic formula “Shengxian Decoction” by Zhang Xichun, a famous doctor in modern times. After more than ten years of research and development and clinical trials, it has become the first innovative Chinese medicine in China that is clearly targeted at frequent tension headaches (Qi and Blood Deficiency Syndrome) . The new product has a large potential market demand. According to the “Guidelines for the Diagnosis and Treatment of Tension-Type Headache in China” (2023) compiled and released by the Chinese Society ...
- Source: drugdu
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- December 22, 2025
The battle for rivaroxaban intensifies! Guilin Pharmaceutical enters the fray with its first generic dry suspension

From December 8th to December 14th , a total of 65 varieties passed/were deemed to have passed the consistency evaluation. During the same period, 69 varieties applied for consistency evaluation. 01 Guilin Nanfang Pharmaceutical: Rivaroxaban Dry Suspension On December 9th, the official website of the National Medical Products Administration (NMPA) showed that Guilin Nanfang Pharmaceutical’s rivaroxaban dry suspension was officially approved, becoming the first generic and the first product to pass the consistency evaluation in China for this dosage form. Image source: NMPA official website. Rivaroxaban was jointly developed by Bayer and Johnson & Johnson. Since entering China in 2009, it has become one of the oral anticoagulants for the prevention and treatment of venous thrombosis, stroke, and pulmonary embolism. Global sales in 2024 still exceeded RMB 43.8 billion. Intense competition. Currently, 58 companies in China hold approvals for rivaroxaban, expanding into four dosage forms: tablets, granules, dry suspensions, and ...
- Source: drugdu
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- December 22, 2025

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