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Dongcheng Pharmaceuticals Receives Approval for Clinical Trial of 177Lu-LNC1009

On December 7th, Dongcheng Pharmaceutical(002675) issued an announcement stating that its holding subsidiary, Lannacheng, received the drug clinical trial approval notice for 177Lu-LNC1009 injection issued by the National Medical Products Administration on December 5, 2025, and plans to conduct relevant clinical trials in the near future. This drug is a dual-target radiotherapy drug, mainly used for the treatment of patients with FAP-positive and integrin αvβ3-positive advanced malignant solid tumors. The total investment in the research and development of 177Lu-LNC1009 injection is approximately RMB 13.58 million. Currently, there are no similar products on the market domestically or internationally, and no relevant sales data is available. The company emphasizes that the process from drug development to market launch is lengthy and involves uncertainties, reminding investors to be aware of the risks. In the first three quarters of 2025, Dongcheng Pharmaceutical achieved revenue of 2.043 billion yuan and net profit attributable to the ...
- Source: drugdu
- 67
- December 8, 2025
Breakthrough in Domestic Targeted Radiopharmaceuticals

In the fiercely competitive global race for anti-cancer drug development, targeted radiopharmaceuticals are emerging as a rising star in cancer treatment due to their unique advantages of “precise targeting, high efficiency, and low toxicity.” Recently, Shandong Weizhi Zhike Pharmaceutical ‘s 177Lu-PSMA-VG01 injection received implied clinical approval from the NMPA, marking a crucial step forward for domestically produced targeted radiopharmaceuticals in the treatment of prostate cancer. 01 Technical Analysis Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that plays a crucial role in prostate cancer. Normally, PSMA is expressed at low levels in prostate tissue, but its expression increases dramatically after cell carcinogenesis. It is significantly upregulated in hormone-refractory and metastatic prostate cancer, making it an ideal target for molecular targeted therapy of prostate cancer. Mechanistically, PSMA possesses glutamate carboxypeptidase II activity, hydrolyzing N-acetyl-L-aspartyl-L-glutamate (NAAG), regulating extracellular glutamate levels, influencing neurotransmission and the tumor microenvironment, promoting cancer cell growth ...
- Source: drugdu
- 51
- December 8, 2025
Pfizer launches a series of combined attacks

Recently, the CDE (Center for Drug Evaluation) website showed that Pfizer ‘s marketing application for zavigipan nasal spray has been accepted, intended for the treatment of adult migraines. This drug is the world’s first and only CGRP (calcitonin gene-related peptide) receptor antagonist nasal spray formulation for the treatment of acute migraines. 01 Effective in 15 minutes Zavegepant is a third-generation, high-affinity, selective small-molecule CGRP receptor antagonist. Initially developed by Bristol-Myers Squibb (BMS), the drug was licensed globally by Biohaven Pharmaceutical from BMS in 2016, which was responsible for its subsequent clinical development, manufacturing, and commercialization. In May 2022, Pfizer acquired Biohaven for approximately $11.6 billion , officially adding Zavegepant to its neuroscience pipeline. On March 9, 2023, Zavzpret nasal spray became the first CGRP receptor antagonist nasal spray approved by the U.S. FDA for marketing, becoming the world’s first approved CGRP receptor antagonist nasal spray for the treatment of acute ...
- Source: drugdu
- 59
- December 8, 2025
Minhai Biological, a wholly-owned subsidiary of Kangtai Biological, successfully co-hosted the Vaccine Innovation Forum

China Securities Journal – China Securities Network (Wang Luo) — Recently, the award ceremony for the “19th Pharmaceutical Development Award” was held in Beijing. Liu Jiankai, a Director and Vice President of Kangtai Biological and the Executive Deputy General Manager of Beijing Minhai Biological Technology Co., Ltd. (hereinafter referred to as “Minhai Biological”), was honored with the “Outstanding Achievement Award.” It is understood that the Pharmaceutical Development Award is a medical science award established in 1994, primarily recognizing outstanding scientific and technological talents who have achieved breakthrough innovative results in the medical and health fields. Following the award ceremony, multiple academic exchange sessions were held. Among them, the Vaccine Innovation Forum, themed “Focusing on Frontiers, Interdisciplinary Integration, and Translational Application,” was co-organized by Minhai Biological, a wholly-owned subsidiary of Kangtai Biological. The academic event brought together experts including academicians of the Chinese Academy of Engineering, renowned scholars from universities, specialists ...
- Source: drugdu
- 51
- December 8, 2025
Hinova Pharmaceutical’s new drug, Deuterium Enzalutamide Soft Capsules, is included in the National Medical Insurance Directory for the first time

Report (By reporter Meng Tingting) On the evening of December 7, Haichuang Pharmaceutical Co., Ltd. (hereinafter referred to as “Haichuang Pharmaceutical”) announced that its independently developed Deuterium Enzalutamide Soft Capsules passed national medical insurance negotiations and were included in the National Medical Insurance Drug Catalog for the first time. The catalog will be implemented starting January 1, 2026. Deuterium Enzalutamide Soft Capsules (previously known as: HC-1119 Soft Capsules) are a Class 1 new drug independently developed by Haichuang Pharmaceutical for the treatment of metastatic castration-resistant prostate cancer (mCRPC). It is a second-generation androgen receptor (AR) inhibitor and received support from the National Science and Technology Major Project for “Major New Drug Innovation and Development”. These capsules are the first domestically produced innovative drug approved in China for mCRPC patients who have progressed after abiraterone acetate and chemotherapy and have not received a novel AR inhibitor. Compared to other endocrine drugs, ...
- Source: drugdu
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- December 8, 2025
Four Drugs Included in the 2025 National Medical Insurance Drug Catalogue

Securities Daily Online News – On the evening of December 7, Betta Pharmaceuticals announced that the company’s products, Icotinib Hydrochloride Tablets, Ensartinib Hydrochloride Capsules, Befotnib Mesylate Capsules, and Vorolanib Tablets, have been included in the National Essential Medical Insurance, Maternity Insurance and Work-Related Injury Insurance Drug Catalogue (2025). https://finance.eastmoney.com/a/202512073584622051.html
- Source: drugdu
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- December 8, 2025
【EXPERT Q&A】What are the differences between medical device verification and medical device validation?

Drugdu.com expert’s response: Medical device verification and validation are two core aspects of quality management. They have fundamental differences in terms of purpose, scope, methods, and application scenarios, yet they complement each other to jointly ensure the safety and effectiveness of products. Here is a detailed comparative analysis: I. Core Purposes Verification: It answers the question “Has the product been made correctly?” by confirming whether the product strictly adheres to design specifications and technical requirements. Key Question: Do the product’s technical parameters, material properties, software functions, etc., align with the design documents? Example: Checking whether the X-ray dose of a CT scanner complies with the safety threshold specified in the design documents. Validation: It answers the question “Has the correct product been made?” by confirming whether the product can meet user needs and intended uses in real-world usage scenarios. Key Question: Is the product safe and effective under actual clinical, ...
- Source: drugdu
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- December 8, 2025
【EXPERT Q&A】What certifications are required for the export of medical products to Malaysia?

Drugdu.com expert’s response: Medical products exported to Malaysia must primarily obtain certification from the Malaysian Medical Device Authority (MDA), with specific requirements varying based on the product’s risk classification (Classes A-D). Here is a detailed explanation: I. Basic Requirements for MDA Certification 1. Corporate Qualifications Local Registration: Companies must register with the Companies Commission of Malaysia (SSM) and obtain a business license. It is recommended to register as a private limited company (Sdn. Bhd.), which allows 100% foreign ownership, provided there is at least one Malaysian director (who does not need to hold shares). Authorized Representative (AR): If the manufacturer is a foreign enterprise, a local Authorized Representative (AR) in Malaysia must be appointed. The AR assists in communication with the MDA and submission of applications. The AR must obtain a Good Distribution Practice for Medical Devices (GDPMD) certificate, issued by an MDA-authorized Conformity Assessment Body (CAB). This certificate is ...
- Source: drugdu
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- December 5, 2025
Breaking the Mold and Forging a New Path! From Insulin Technology Pioneer to Global Innovation Competitor

It’s already spinning like a top… Starting in September, executives from Dongbao Pharmaceutical, based in Tonghua-Beijing, Beijing-Shanghai, and Shanghai-Tonghua, frequently gathered in Tonghua, Jilin Province, during weekend breaks for a series of strategic meetings. Sales targets, annual budget, three-year plan, ten-year vision, resource allocation, organizational arrangements, incentive mechanisms… This “strategic list,” compiled by Chairman Li Jiahong after officially taking over, is backed by a core management team that combines the “industry experience of veterans” with the “innovative vitality of newcomers.” They are driving this 40-year-old company with unprecedented urgency, propelling it onto a new, repeatedly validated path . This waterway carries the past glory of China’s insulin industry and points to the future direction of innovation and transformation for traditional pharmaceutical companies. Like all large-scale traditional pharmaceutical companies that have grown up in the wave of reform and opening up, Dongbao Pharmaceutical’s genes are marked by the times: with its ...
- Source: drugdu
- 88
- December 4, 2025
A subsidiary of Kingfriend Pharmaceutical Co., Ltd. has received FDA approval for its self-developed injectable dapavancin

Recently, Kingfriend Pharmaceutical Co., Ltd.The company announced that it recently received notification from the U.S. Food and Drug Administration (FDA) that its Chengdu subsidiary, Jianjin Pharmaceutical Co., Ltd., has officially approved the injectable dapavancin for sale in the United States. The first batch of products was shipped to the U.S. under controlled conditions in early November. According to reports, dapavancin for injection is primarily used to treat acute bacterial skin and skin structure infections in adults and pediatric patients. Related data shows that in 2024, the drug’s market size in the United States exceeded $250 million, while no similar products have yet been approved in the Chinese market. Kingfriend Pharmaceutical stated that this approval not only further enriches its product pipeline in the US market but also makes Kingfriend Pharmaceutical the first domestic company to obtain international approval for this product. https://finance.eastmoney.com/a/202512023580381538.html
- Source: drugdu
- 82
- December 4, 2025

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