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Paliperidone API Receives Marketing Approval

PKU HealthCare announced on the evening of March 17 that it recently received the ” Chemical Raw Materials” certificate issued by the National Medical Products Administration. The drug marketing application approval notice was issued, and the submitted product “paliperidone (packaging specifications: 1kg/bag, 5kg/bag, 10kg/bag)” was approved for registration after review, meeting the relevant requirements for drug registration. Data shows that paliperidone is the main active metabolite of risperidone. It is a second-generation antipsychotic drug with strong control effects, high affinity, tolerability and efficacy. It is mainly used to treat schizophrenia in adults and adolescents aged 12-17 (weight ≥29Kg). PKU HealthCare stated that paliperidone raw material The approval will help the company further promote its “raw material and formulation integration” strategy, create synergies with formulation products, enhance its competitiveness in production cost control and supply chain stability, and have a positive effect on the company’s future performance. https://finance.eastmoney.com/a/202603173674705264.html
- Source: drugdu
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- March 18, 2026
Subsidiary obtains registration certificate for antidepressant drug

March 17th – Jiuzhou PharmaceuticalThe company issued an announcement stating that its wholly-owned subsidiary, Jiuzhou Biopharmaceutical (Taizhou) Co., Ltd. (formerly Zhejiang Siwei Pharmaceutical Technology Co., Ltd.), received the Drug Registration Certificate for Vortioxetine Hydrobromide Tablets issued by the National Medical Products Administration. The approved drug is vortioxetine hydrobromide tablets, available in tablet form (5mg and 10mg) and classified as a Class 4 chemical drug. This drug is primarily used for the treatment of major depressive disorder (MDD) in adults. Vortioxetine hydrobromide tablets are manufactured by Lundbeck (Denmark) and Takeda (Japan).The product was jointly developed and approved for market launch in the United States in September 2013, and in China in November 2017. According to the announcement, the total sales (terminal price) of vortioxetine hydrobromide tablets in the domestic medical and retail markets in 2024 were approximately RMB 214 million. As of the date of the announcement, Jiuzhou Pharmaceutical ‘s cumulative ...
- Source: drugdu
- 55
- March 18, 2026
Fosun Pharma’s subsidiary, Junji Health, has received clinical trial approval from the National Medical Products Administration for its LBP-ShC4 product.

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced that its subsidiary, Shanghai Junji Health Technology Co., Ltd., has received approval from the National Medical Products Administration (NMPA) of China for its independently developed in vivo biological therapy product, LBP-ShC4, to conduct clinical trials in China. The product is intended for the treatment of androgenetic alopecia (AGA). Previously, clinical trials for the same indication were approved by the U.S. Food and Drug Administration (FDA) in May 2025. According to the announcement, as of February 2026, Fosun Pharmaceutical Group’s cumulative R&D investment in LBP-ShC4 was approximately RMB 20 million. Currently, there are no in vivo biological therapy products (including monotherapy or combination therapy) approved for the treatment of androgenetic alopecia globally. Fosun Pharmaceutical stated that LBP-ShC4 still needs to complete a series of clinical studies in China and obtain approval from the NMPA before it can be marketed. The company also cautioned that ...
- Source: drugdu
- 53
- March 18, 2026
A world first! my country achieves regenerated islet transplantation, opening a new path for diabetes treatment.

Reporters learned from the Center for Excellence in Molecular Cell Science (Institute of Biochemistry and Cell Biology), Chinese Academy of Sciences, that Professor Cheng Xin’s research group at the center, in collaboration with Professor Yin Hao’s team at the Second Affiliated Hospital of Naval Medical University (Shanghai Changzheng Hospital), recently achieved, for the first time internationally, minimally invasive transplantation of regenerated islets (E-islets) derived from autologous and allogeneic stem cells, enabling pancreatic islet function reconstruction and autonomous blood glucose regulation in patients with type 1 diabetes. The relevant findings have been published online in the international academic journal *The Lancet Diabetes & Endocrinology*. Diabetes is a chronic disease that seriously threatens the health of Chinese residents, with type 1 diabetes being most prevalent in children and adolescents. Due to autoimmune disorders and the body’s immune system’s abnormal attack and destruction of pancreatic beta cells, pancreatic function fails, insulin secretion is ...
- Source: drugdu
- 51
- March 18, 2026
How long until the first generic version?

The first generic version of smegglutide is getting closer and closer. Yesterday, the CDE updated a common issue regarding peptide formulations, which can be seen as pointing out a direction for companies following suit. Q: How should clinical trial applications and marketing authorization applications be submitted for polypeptide preparations developed using bio-fermentation-derived polypeptide preparations as control drugs and prepared by a fully chemical synthesis method? A: If there are no similar products prepared entirely by chemical synthesis on the market, both domestically and internationally, the applicant may apply for a product in accordance with the category 2.2 of chemical drugs. If there are already generic versions of the same drug prepared by full chemical synthesis on the market in China and abroad, the generic drugs already on the market overseas shall be submitted in accordance with the category 5.2 of chemical drugs, and the drugs produced by the applicant in ...
- Source: drugdu
- 55
- March 18, 2026
Haizheng Pharmaceutical’s Haibomaibu Atorvastatin Calcium Tablets Approved for Clinical Trials

On March 13, 2026, Hanhui Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Hisun Pharmaceutical, received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration for a new specification of Hybromide Atorvastatin Calcium Tablets (Hybromide 10mg/Atorvastatin 20mg) . After review, the National Medical Products Administration approved the direct commencement of Phase I and Phase III clinical trials for this product.The development of this new specification represents a further expansion of the company’s existing Hybromide-Atorvastatin combination formulation (10mg/10mg and 20mg/10mg specifications) , which is currently under market review. Closely aligned with clinical practice and market demand, it aims to provide patients with hyperlipidemia with a wider range of personalized lipid-lowering treatment options. The approval to directly enter Phase I/III clinical trials demonstrates the high recognition of the product’s preliminary research data and clinical value by the national drug regulatory agency, and will significantly shorten the development and market ...
- Source: drugdu
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- March 18, 2026
【EXPERT Q&A】What are the major steps in an FDA application?

Drugdu.com expert’s response: The steps for FDA application can be summarized into the following core stages, taking into account the commonalities and differences among product types (food, drugs, medical devices, etc.). The specific process is as follows: I. Preliminary Preparation: Clarify Product Classification and Regulatory Requirements 1. Determine Product Classification Food: Classified into general food, special food (e.g., infant food), dietary supplements, etc. Some require FCE/SID registration (e.g., low-acid canned food). Drugs: Classified into new drugs (NDA), generic drugs (ANDA), biological products (BLA), etc., with different application paths for each category. Medical Devices: Classified into Class I (low risk), Class II (medium risk), and Class III (high risk) based on risk level, determining the application type (e.g., 510(k), PMA). 2. Confirm Regulatory and Standard Requirements Comply with regulations such as the Federal Food, Drug, and Cosmetic Act (FDCA) and the Medical Device Amendments. Reference international standards (e.g., ISO 13485, IEC ...
- Source: drugdu
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- March 18, 2026
Kanghua Bio’s ACYW135 group meningococcal conjugate vaccine has been approved for clinical trials, marking another key breakthrough in its R&D pipeline.

On March 16, 2026, Chengdu Kanghua Biological Products Co., Ltd. (stock code: 300841, stock abbreviation: Kanghua Bio) issued an announcement stating that its ACYW135 group meningococcal conjugate vaccine has officially obtained the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration, and is authorized to conduct clinical trials against epidemic cerebrospinal meningitis (hereinafter referred to as “meningococcal”) caused by meningococcal groups A, C, Y and W135. This marks a core step forward for this domestic vaccine company in the technological upgrading and pipeline improvement of the meningococcal vaccine field. According to the announcement, the ACYW135 group meningococcal conjugate vaccine, which has been approved for clinical trials, has the application number CXSL2501077, is classified as a Class 3.3 drug, and has the clinical trial approval notice number 2026LP00672. The National Medical Products Administration’s approval conclusion indicates that the vaccine meets the relevant requirements for drug registration and approves ...
- Source: drugdu
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- March 17, 2026
Humanwell Healthcare Group has released another blockbuster product! Its marketing application for acetaminophen/oxycodone extended-release tablets has been accepted.

Today (March 12, 2026), according to the latest announcement on the CDE website, Yichang Renfu Pharmaceutical’s application for marketing authorization of acetaminophen-oxycodone extended-release tablets , a Class 2.2 improved new drug , has been accepted. As a leading company in the domestic anesthesia and analgesia field, Renfu Pharmaceutical’s move not only enriches its analgesic product pipeline but also targets unmet clinical needs in the treatment of moderate to severe pain. Image source: CDE official website Acetaminophen/oxycodone extended-release tablets are a potent centrally acting analgesic , composed of the opioid analgesic oxycodone and the nonsteroidal anti-inflammatory drug acetaminophen. The two work synergistically to ensure analgesic efficacy while optimizing medication safety. Its core competitive advantage lies in its extended-release formulation design—compared to existing immediate-release formulations, this extended-release tablet allows for prolonged administration, reducing the frequency of dosing and significantly improving patient adherence. With its advantages of ” potent analgesia + optimized safety ...
- Source: drugdu
- 51
- March 17, 2026
Eli Lilly invests $3 billion in China

Recently, Eli Lilly announced plans to invest a total of $ 3 billion over the next ten years to fully expand its supply chain capacity in China . According to the plan, the $3 billion investment will adopt a dual-track model of ” internal expansion + external cooperation “: on the one hand, it will leverage the technological and talent advantages of the Suzhou factory to strengthen the synergistic production capacity of incretin injection; on the other hand, it will add oral solid dosage form production capacity in Beijing and cooperate with multiple local production partners to release incremental production capacity. As a key move in this round of investment, Eli Lilly also announced a strategic partnership with Kanglong Chemical , a leading domestic CDMO company , on the same day. The initial investment of $200 million will support Kanglong’s technological capabilities, with plans to gradually expand the scale as ...
- Source: drugdu
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- March 17, 2026

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