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A Comparative Overview of the US, EU, China, India and Brazil

Against the backdrop of rapid internationalization of pharmaceutical formulations, pharmaceutical excipients – as critical components supporting drug quality and stability – are receiving increasing attention in regulatory frameworks worldwide. For excipient manufacturers planning to expand into overseas markets, understanding the compliance thresholds and regulatory focus of major markets is a necessary prerequisite for designing a global export strategy. Drawing on practical registration experience and international regulatory practices, we compare excipient regulations across five key markets – the United States, the European Union, China, India and Brazil – to help companies build a global compliance framework for excipients. At a Glance: Regulatory Requirements Across Five Major Markets Regional Regulatory Focus – Detailed Analysis United States: Well-established DMF system with emphasis on data transparency The FDA reviews excipients in the context of finished drug product applications. Manufacturers may choose to submit a Type IV DMF (Drug Master File for excipients). Although it ...
- Source: drugdu
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- December 3, 2025
Yuzhiyou Biotechnology Publishes Results of Phase II Clinical Trial of M701 in China

On December 2, YOZY Bio (02496) issued an announcement stating that the results of its independently developed bispecific antibody drug M701 in the Phase II clinical trial in China have been published in the internationally renowned medical journal Experimental Hematology & Oncology. This study included 84 patients, of whom 43 received intraperitoneal infusion of M701. The median puncture-free survival was 75 days in the M701 group and 25 days in the control group, a significant difference (p=0.0065). The 6-month survival rate was 33.3% in the M701 group and 12.1% in the control group. No other serious adverse events were observed in the M701 group. M701 is a bispecific antibody that targets the tumor cell target EpCAM and the immune T cell activation target CD3, aiming to eliminate tumor cells in the peritoneal cavity by activating T cells. Currently, M701 is undergoing multiple clinical trials at different stages for malignant ascites ...
- Source: drugdu
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- December 3, 2025
YueKang KeXiang YKYY018 nebulizer has obtained clinical approval from both China and the United States

It has been learned that recently, the company’s subsidiary, Beijing Yuekang Kechuang Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Yuekang Kechuang”), received a letter from the U.S. Food and Drug Administration approving the clinical trial of YKYY018 nebulizer for the prevention and treatment of respiratory syncytial virus (RSV) infection, and two Drug Clinical Trial Approval Notices issued by the National Medical Products Administration approving the use of YKYY018 nebulizer for post-exposure prophylaxis after contact with patients with respiratory syncytial virus and for the treatment of RSV infection. The company will conduct Phase I clinical trials of this product. Respiratory syncytial virus (RSV) is a ubiquitous and infectious enveloped RNA virus that causes respiratory illnesses, particularly affecting vulnerable groups such as children, the elderly, and those with compromised immune systems. Currently, there are no approved treatments for RSV infection worldwide, indicating a significant and urgent unmet clinical need. YKYY018 nebulized ...
- Source: drugdu
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- December 3, 2025
IND Application for Study of ATG-022 in Combination with KEYTRUDA® Granted Approval

On December 2nd, Antengene (06996) announced that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application for a Phase IB/II study of ATG-022 in combination with KEYTRUDA® (pembrolizumab) and chemotherapy. This approval will help advance the company’s R&D efforts in treating diseases with unmet medical needs. In the announcement, the company mentioned that ATG-022 is a CLDN18.2 antibody-drug conjugate (ADC), and the study combining it with MSD’s anti-PD1 therapy KEYTRUDA® will provide new treatment options for patients. The approval of this study marks further progress for the company in the biotechnology field and enhances its competitiveness in the market. https://finance.eastmoney.com/a/202512023580471418.html
- Source: drugdu
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- December 3, 2025
Abbisko Therapeutics’ Oral Small Molecule KRAS G12D Inhibitor Approved for Clinical Trials in the US

Abbisko Therapeutics announced that its investigational oral, highly active, highly selective small molecule KRAS G12D inhibitor, ABSK141, has received approval from the US Food and Drug Administration (FDA) for an Investigational New Drug (IND) application to treat patients with advanced solid tumors harboring the KRAS G12D mutation. Commentary: The announcement by Abbisko Therapeutics that its oral KRAS G12D inhibitor ABSK141 has received FDA IND approval is a critical R&D advancement. This drug targets the KRAS G12D mutation, for which there are currently no approved targeted therapies. This mutation is one of the most common oncogenic mutations in various solid tumors, including pancreatic and colorectal cancers, highlighting a pressing clinical need. https://finance.eastmoney.com/a/202512033580752973.html
- Source: drugdu
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- December 3, 2025
Rare Disease Drugs Become More Accessible as Domestic Innovative Medicines Enter the “Fast Lane”

Not long ago, at Xinhua Hospital affiliated with Shanghai Jiao Tong University School of Medicine, 14-year-old Gaucher disease patient Xiao Ai began treatment with a new domestically developed drug. “Having access to an affordable medicine brings much more peace of mind,” said Xiao Ai’s mother, who felt a sense of relief she hadn’t experienced in a long time. For rare disease medications, which have long been reliant on imports and carried high price tags, more “Made in China” options are now emerging. “True pharmaceutical innovation must ultimately demonstrate its value in patient accessibility and the dignity of life,” said Xue Qun, Founder, Chairman, and CEO of the drug R&D company CanoCan. He added that the future will involve a continued focus on unmet clinical needs, ensuring that more new and effective medicines benefit patients. Rare diseases serve as a measure of a society’s compassion. The journey of this new drug—from ...
- Source: drugdu
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- December 3, 2025
Focused on Autoimmune Disease and Oncology Drug Development, with Cumulative Losses Exceeding 300 Million Yuan Over Three Years

Recently, Ganzhou Hemei Pharmaceutical Co., Ltd. (hereinafter referred to as “Hemei Pharmaceutical”), headquartered in Ganzhou, Jiangxi, formally submitted its prospectus to the Hong Kong Stock Exchange, planning to list on the Main Board of Hong Kong. SDIC Securities Financing (Hong Kong) Limited acted as the sole sponsor. According to the prospectus reviewed by Daily Economic News, Hemei Pharmaceutical was founded in 2002 and focuses on developing small-molecule drugs for autoimmune diseases and oncology. The company currently has one approved product and multiple pipeline drugs in clinical stages. However, Hemei Pharmaceutical has yet to achieve profitability. The prospectus indicates that from 2023 to the first half of 2025, the company accumulated a net loss of over RMB 350 million, with R&D expenditure being the primary cost. To date, the company has completed seven rounds of financing, with a valuation of RMB 3.9 billion after the most recent round. Pipeline Covers 7 ...
- Source: drugdu
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- December 3, 2025
In the multi-billion dollar cardiovascular market, these two targets have become the “new favorites”

In recent years, the field of cardiovascular disease treatment has been undergoing a profound transformation. PCSK9 and Lp(a), two emerging targets, have emerged as hotly contested areas for multinational pharmaceutical companies, ushering in a new golden age for cardiovascular disease treatment. 1 Two golden targets are coming Atherosclerotic cardiovascular disease (ASCVD) is a collective term for a group of diseases affecting blood vessels and the heart throughout the body caused by atherosclerosis, including coronary heart disease, cerebrovascular disease, and peripheral artery disease. ASCVD is one of the leading causes of death worldwide. The Global Burden of Disease Study shows that ischemic heart disease has consistently ranked as the leading cause of death globally in both 1990 and 2021. In China, there are approximately 500 million adults with dyslipidemia, of whom about 120 million have hypercholesterolemia. Statins are the cornerstone of lipid-lowering therapy for dyslipidemia. They reduce cholesterol synthesis by inhibiting ...
- Source: drugdu
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- December 3, 2025
Another milestone for Baili Tianheng

Recently, Baileyn announced that it has received a milestone payment of $250 million from BMS. Previously, in December 2023, Baili Tianheng entered into an exclusive licensing and collaboration agreement with BMS for its world-first-in-class EGFR×HER3 bispecific antibody ADC project iza-bren (BL-B01D1) to jointly develop and commercialize it globally. Under the agreement, BMS will pay the company an upfront payment of $800 million and two contingent payments of $250 million in the near future; upon achieving development, registration, and sales milestones, the company will receive additional payments of up to $7.1 billion; the potential total transaction value could reach up to $8.4 billion. In September of this year, Baili Tianheng’s global Phase II/III pivotal registration clinical trial, IZABRIGHT-Breast01, reached a milestone, triggering this payment. This is the largest milestone payment for a single ADC asset in any disclosed overseas transaction of a domestic innovative drug to date. Baili Tianheng is collaborating ...
- Source: drugdu
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- December 3, 2025
【EXPERT Q&A】When should the continuation registration process for medical devices be initiated?

Drugdu.com expert’s response: The continuation registration of medical devices should generally be applied for with the original registration authority six months before the expiration of the medical device registration certificate. Here is a detailed explanation: I. Legal Basis Regulations on the Supervision and Administration of Medical Devices: It explicitly stipulates that the validity period of a medical device registration certificate is five years. If continuation registration is required upon expiration, an application for continuation registration should be submitted to the original registration authority six months before the expiration date. Measures for the Registration and Filing of Medical Devices: It further refines the application process and requirements for continuation registration, emphasizing that enterprises need to submit applications within the specified time to ensure the validity of the registration certificate. II. Application Time Requirements Apply six months in advance: Enterprises should submit an application for continuation registration to the original registration authority ...
- Source: drugdu
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- December 3, 2025

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