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【EXPERT Q&A】What is the current situation of high-end medical equipment in China?

Drugdu.com expert’s response: Currently, China’s high-end medical equipment industry is at a critical stage of rapid rise and transformation. Driven by policy support, technological breakthroughs, and an upgrading market demand, it is undergoing a historic leap from “following the lead” to “running alongside” and even “taking the lead” in certain fields. However, the industry as a whole still faces challenges such as achieving breakthroughs in core technologies, increasing market share, and enhancing international competitiveness. Below is a detailed analysis of the current state of China’s high-end medical equipment industry: Market Size and Growth Continued Market Expansion: China has become the world’s second-largest medical instrument market, with the high-end medical device sector also experiencing continuous growth. For instance, in 2024, the market size of high-end medical devices in China reached RMB 580 billion, marking a year-on-year increase of 21.3%, significantly outpacing the global average growth rate. Robust Growth in Sub-sectors: From ...
- Source: drugdu
- 49
- January 12, 2026
Betamethasone Sodium Phosphate Injection Approved

On January 8th, Xianju Pharmaceutical…(002332) issued an announcement stating that the company recently received the “Drug Registration Certificate” for betamethasone sodium phosphate injection issued by the National Medical Products Administration. The specification of betamethasone sodium phosphate injection is 1ml:4mg (calculated as CHFO), and it is submitted for approval as a Class 3 chemical drug. The reference preparation for this drug is betamethasone sodium phosphate injection marketed in the European Union, under the brand name Celestone®. In the first three quarters of 2025, Xianju Pharmaceutical achieved revenue of RMB 2.826 billion and net profit attributable to the parent company of RMB 407 million. https://finance.eastmoney.com/a/202601083613015592.html
- Source: drugdu
- 64
- January 9, 2026
OpenAI releases two AI products in the healthcare field.

Recently, OpenAI released two AI products related to the healthcare field: ChatGPT Health for consumers and OpenAI for Healthcare for medical institutions. ChatGPT Health, integrated into ChatGPT, is a “dedicated space for health-related conversations with ChatGPT.” It connects to electronic medical records and various health applications, generating responses that incorporate the user’s health information and personal context. OpenAI for Healthcare is a suite of products designed to help healthcare institutions provide more consistent and higher-quality care to patients. It can be used to create reusable discharge summaries and patient guidance templates, or to analyze medical evidence for application to specific patients. https://finance.eastmoney.com/a/202601093613575432.html
- Source: drugdu
- 64
- January 9, 2026
Say goodbye to lifelong medication? Hepatitis B patients may be entering an era of “functional cure”.

On January 7th local time, the British pharmaceutical company GlaxoSmithKline…GSK announced that its investigational chronic hepatitis B therapy, Bepirovirsen, met its primary endpoints in two pivotal Phase 3 clinical trials. If approved, this would mean the world’s first antiviral therapy that can achieve functional cure of hepatitis B with only a limited 6-month treatment course. Bepirovirsen is a novel antisense oligonucleotide (ASO) antiviral therapy for hepatitis B that directly inhibits viral replication. GSK plans to formally initiate global regulatory approval applications for Bepirovirsen in the first quarter of this year. The term “functional cure” refers to a condition where, after discontinuing medication, the patient remains negative for hepatitis B surface antigen (HBsAg) and has undetectable hepatitis B virus (HBV) DNA for six months or longer. Analysts believe that even if only 15% to 20% of hepatitis B patients achieve functional cure, it will have significant implications for changing global hepatitis ...
- Source: drugdu
- 81
- January 9, 2026
Xuantai Pharmaceutical’s “Isaconazole Sulfate for Injection” has been approved for marketing by the National Medical Products Administration, enriching new options for antifungal treatment

Recently, Xuantai Pharmaceutical received a Drug Registration Certificate issued by the National Medical Products Administration, officially approving the marketing of its independently developed “Isaconazole Sulfate for Injection ,” bringing new hope for the treatment of fungal infections in China! Targeting essential clinical needs and enriching the product pipeline The newly approved isaconazole sulfate for injection is an injectable formulation with a strength of 0.2g (calculated as C₂₂H₁₇F₂N₅OS), indicated for the treatment of invasive aspergillosis and invasive mucormycosis in adults . These two types of infections are serious invasive fungal infections, posing a significant threat to high-risk groups such as those with weakened immune systems, and there is an urgent clinical need for their treatment. It is understood that the original drug was developed by Pfizer and was quickly included in the National Reimbursement Drug List (NRDL) after being approved in China in June 2022. It has gained widespread clinical recognition ...
- Source: drugdu
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- January 9, 2026
Fosun Pharma resubmits its application for listing of Furuitinib

On January 8, Fosun Pharma announced that its subsidiary, Fosun Wanbang, had its drug registration application for Furetinib Succinate Capsules accepted by the National Medical Products Administration. The indication for this application is for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Furetinib is a highly effective ALK/ROS1 inhibitor with high CNS penetration . It has demonstrated good efficacy in clinical studies, showing significant efficacy against central nervous system metastases, and exhibiting a good safety profile . In March 2025, Fosun Pharma initially submitted a marketing application for Furetinib, but voluntarily withdrew it in October, citing the need to further refine the registration materials according to the latest technical requirements of the National Medical Products Administration (NMPA). Interim analysis results from the Phase II REMARK study showed that the progression-free survival (PFS) in the fosetinib (160 mg once daily) group ...
- Source: drugdu
- 57
- January 9, 2026
the treatment of generalized anxiety disorder

Luye Pharma Group announced that the Center for Drug Evaluation of the National Medical Products Administration of China has formally accepted the new indication marketing application for the Group’s Class 1 innovative drug Ruoxinlin® ( toludivinlafaxine hydrochloride extended-release tablets), which is intended for the treatment of generalized anxiety disorder (GAD). This application for a new indication marks another milestone for Ruoxin® since its approval for marketing in November 2022 for the treatment of depression. As the review process for the new indication progresses, this product is expected to become the first serotonin, norepinephrine, and dopamine triple reuptake inhibitor (SNDRI) for the treatment of GAD in China, benefiting more patients. It rapidly and comprehensively improves anxiety symptoms and has a good safety profile. Anxiety disorders are the most common mental disorders in China.1 Data from 2023 shows that approximately 58.67 million people in China suffer from this disease.2 GAD is a ...
- Source: drugdu
- 59
- January 9, 2026
The first prescription of the rare disease innovative drug sradpa in mainland China was issued in Shunyi.

On the morning of January 6, Beijing Friendship Hospital Shunyi Branch issued the first prescription in mainland China for the innovative rare disease drug Seladelpar, which is specifically used to treat primary biliary cholangitis. This not only marks a significant step forward in the treatment of rare diseases in my country, but also provides a model for the introduction of more innovative drugs. At the Shunyi branch of Beijing Friendship Hospital, patient Liu Li (pseudonym) received the first box of sradpa prescribed in mainland China. Liu Li had been diagnosed with primary biliary cholangitis for many years. After trying her current first-line treatments, her indicators did not improve significantly. After thorough communication, she decided to try the innovative rare disease drug sradpa. “I hope this innovative drug can improve my condition, and I also hope that such drugs will be included in medical insurance as soon as possible, benefiting more ...
- Source: drugdu
- 50
- January 9, 2026
Yilian Bio and Roche Sign Another Exclusive Licensing Agreement

Suzhou, China, January 9, 2026 – Yilian Bio today announced a new exclusive licensing agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) for its YL201 project, which will jointly advance the development and commercialization of this innovative antibody-drug conjugate (ADC) targeting B7H3 in multiple solid tumor indications. Under the terms of the agreement, Yilian Bio will grant Roche the exclusive rights worldwide (excluding Mainland China, Hong Kong SAR, and Macau SAR) to develop, manufacture, and commercialize the YL201 project. Yilian Bio will receive an upfront payment of US$570 million plus near-term milestone payments, and will be entitled to additional development, registration, and commercialization milestone payments, as well as tiered royalties based on net sales following overseas approval of YL201. This exclusive licensing agreement for the YL201 project builds upon the successful collaboration initiated by both parties in January 2024 regarding the YL211 (c-Met ADC) project. Yilian Bio and Roche will ...
- Source: drugdu
- 54
- January 9, 2026
【EXPERT Q&A】What are the evaluation criteria for the verification of clinical trials of Class II medical devices?

Drugdu.com expert’s response: The evaluation criteria for the inspection of clinical trials for Class II medical devices primarily encompass three levels: regulations, technical specifications, and specific inspection points, as detailed below: I. Regulatory Basis: Establishing the Top-Level Framework for Inspections Medical Device Supervision and Administration Regulations As the foundational legislation for medical device regulation, it clarifies the management principles for clinical trials, including core requirements such as trial design, subject protection, and data authenticity, providing a legal basis for inspections. Medical Device Registration and Filing Administration Measures This regulates the medical device registration process, emphasizing clinical trials as a critical component of registration applications. It mandates that clinical trial data submitted must be authentic, complete, and traceable, offering procedural guidance for inspections. In Vitro Diagnostic Reagent Registration and Filing Administration Measures Specifically tailored to Class II in vitro diagnostic reagent medical devices, this refines special requirements for clinical trials, such ...
- Source: drugdu
- 58
- January 9, 2026

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