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Fosun Pharma’s blockbuster drug receives approval for two new indications, marking the first time a domestically developed drug has been approved for marketing

On April 9, 2026, Fosun Pharma subsidiary Henlius announced that its supplemental applications for two new indications for rituximab ( Hanlikang® ) , developed and manufactured in-house, were approved by the NMPA (National Medical Products Administration). As the first biosimilar in China, rituximab now fully covers all indications approved for the original rituximab in China , including non-Hodgkin’s lymphoma , chronic lymphocytic leukemia, and rheumatoid arthritis, which was not approved in China for the original drug. This makes it the rituximab with the most approved indications in China*. Public information shows that rituximab injection is a monoclonal antibody that targets CD20 . It binds to CD20 molecules expressed on the surface of B lymphocytes and kills tumor B cells through antibody-dependent cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). It is used to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia and other non-tumor diseases.It is understood that rituximab was originally developed by Roche’s ...
- Source: drugdu
- 50
- April 13, 2026
【EXPERT Q&A】Is it necessary to conduct environmental test-related inspections during the CE registration of active medical devices?

Drugdu.com expert’s response: Active medical devices typically require environmental test-related inspections during CE registration, which is a necessary step to meet the General Safety and Performance Requirements (GSPR) under the EU Medical Device Regulation (MDR 2017/745) or the older Directive (MDD 93/42/EEC). Below is a detailed analysis of this requirement: I. Regulatory Basis and Core Requirements Regulatory Requirements According to EU medical device regulations, technical documentation must include “evidence of the device’s suitability under normal and extreme environmental conditions.” Environmental testing is a crucial means to demonstrate this, ensuring that the product remains compliant with safety and performance requirements under varying climatic and mechanical stress conditions. Risk Control Electronic components, batteries, sensors, and other parts of active devices (such as monitors and ventilators) are susceptible to factors like temperature, humidity, and vibration. Environmental testing can expose potential defects (e.g., circuit failures, material degradation) in advance, reducing clinical risks. II. Specific ...
- Source: drugdu
- 85
- April 13, 2026
Yingen Biotech’s first innovative drug application for market launch

On April 9, the CDE website showed that Yingen Biotech’s first ADC drug, trastuzumab perconcave (DB-1303/BNT323), submitted a marketing application. This is Yingen Biotech’s first innovative drug to apply for market approval. In September 2025, the Phase III clinical trial (DYNASTY Breast02) of trastuzumab versus T-DM1 for the treatment of patients with HER2-positive unresectable or metastatic breast cancer who had previously received trastuzumab and taxane therapy met its primary endpoint, namely a significant prolongation of progression-free survival (PFS). Trastuzumab pac-ascorbic acid (TAA) is a clinical-stage HER2 ADC candidate that employs a stable, cleavable linker and a proprietary topoisomerase inhibitor-based payload design to reduce off-target toxicity and enhance antitumor activity, including bystander-killing effects. These characteristics may make PAC a potential new treatment option for patients with advanced HER2-expressing solid tumors, including those with both high and low HER2 expression. Trastuzumab perconcanava has received Fast Track and Breakthrough Therapy designations from the ...
- Source: drugdu
- 80
- April 10, 2026
Chia Tai Tianqing’s Pan-KRAS inhibitor TQB3205 receives dual clinical trial approval in China and the United States.

Following its approval for clinical trials in China in March, TQB3205, an innovative Class 1 oral Pan-KRAS inhibitor independently developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (a core subsidiary of Sino Biopharmaceutical Co., Ltd., received approval from the U.S. Food and Drug Administration (FDA) on April 4th (local time) to conduct clinical trials for advanced malignant tumors . The simultaneous acquisition of clinical access qualifications in both the U.S. and Chinese pharmaceutical markets signifies that TQB3205’s preclinical data and innovative mechanism of action have been recognized by internationally authoritative regulatory agencies, potentially providing a new “broad-spectrum treatment option” for pan-KRAS mutation patients worldwide. KRAS gene mutations are among the most common driver genes in human cancers, associated with approximately 30% of cancer cases worldwide, particularly prevalent in high-incidence cancers such as pancreatic cancer (approximately 90%), colorectal cancer (30%-50%), and non-small cell lung cancer (15%-20%) [1-2] . For a ...
- Source: drugdu
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- April 10, 2026
Filling a clinical gap! Dongyangguang Pharmaceutical’s marketing application for Vonoprazan injection has been accepted.

On April 8, 2026, the National Medical Products Administration (NMPA) accepted the marketing authorization application (NDA) for Dongyangguang Pharmaceutical’s independently developed improved new drug, vonoprazan fumarate sodium chloride injection (hereinafter referred to as “vonoprazan injection”). The indication for this drug is: treatment of peptic ulcer bleeding. The vonoprazan injection submitted for approval this time is an innovative dosage form developed based on the oral formulation vonoprazan fumarate tablets (trade name: Vocinti® ) , and is classified as a Class 2 new drug. The introduction of this injectable formulation effectively fills a clinical gap that oral formulations cannot meet, and is particularly suitable for high-risk patients with rebleeding peptic ulcers who are unable to take oral medication due to the severity of their condition. In addition, this drug is a ready-to-use large-volume infusion, which eliminates the need for on-site preparation in clinical use, effectively reducing the risk of contamination by pathogens ...
- Source: drugdu
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- April 10, 2026
Breaking Through the “Irreversible” Petrification of the Heart – ATTR-CM Treatment Shifts from Defense to Counterattack

The story of transthyretin amyloid cardiomyopathy (ATTR-CM) begins with the structural instability of a protein. Under normal circumstances, TTR proteins transport thyroxine and vitamin A in the blood as tetramers, maintaining a stable structure and each fulfilling its function. However, under the influence of aging or specific gene mutations, the tetramer dissociates into monomers. These monomers misfold and aggregate into non-degradable amyloid fibers. Once these fibers deposit in the myocardial interstitium, the heart wall thickens and hardens, leading to decreased compliance, gradual loss of diastolic function, and ultimately heart failure. For a long time, the clinical approach to these diseases was essentially defensive, using drugs to stabilize the protein structure, slow down the deposition rate, and prolong the disease course as much as possible. As for the fibers already embedded in the myocardium, it was generally accepted that there was nothing that could be done. However, in recent years, this ...
- Source: drugdu
- 81
- April 10, 2026
China’s first to be approved for listing!

Today, GlaxoSmithKline (GSK) announced that its innovative biologic, Easily (demozimab) , has been approved by the NMPA for the treatment of adult patients with chronic sinusitis with nasal polyps (CRSwNP), making it the first and currently the only ultra-long-acting biologic in China for the treatment of chronic sinusitis with nasal polyps. It is worth noting that this comes only about 10 days after the drug was approved for maintenance treatment of severe eosinophilic asthma, marking the achievement of dual indications in the respiratory field in China for this world’s first IL-5 ultra-long-acting biologic that is administered once every six months . Chronic sinusitis with nasal polyps is a chronic upper respiratory tract disease characterized by type 2 inflammation , affecting approximately 30 million patients in China. Patients suffer from long-term symptoms such as nasal congestion, decreased sense of smell, facial swelling and pain, and sleep disturbances. Traditional treatments have significant ...
- Source: drugdu
- 81
- April 10, 2026
Several domestically produced FIC drugs will make their debut.

The American Association for Cancer Research (AACR) Annual Meeting is one of the largest and most influential academic events in the global oncology field. The 2026 AACR Annual Meeting will be held in San Diego, USA, from April 17 to 22, 2026. Currently, the AACR Annual Meeting has become an important platform for domestic innovative pharmaceutical companies to showcase their latest research results. At this year’s meeting, more than 100 Chinese pharmaceutical companies participated, presenting nearly 400 research results covering cutting-edge fields such as ADCs, bispecific antibodies, multi-antibodies, mRNA, and AI-driven drug development. Biocytogen will showcase 36 of its latest research findings in poster format, including various drug forms such as fully human monoclonal antibodies, bi/multispecific antibodies, monoclonal and bispecific antibody-drug conjugates (ADCs), nanobodies (VHHs), and TCR molecules, as well as 12 advances in preclinical animal models and pharmacological and efficacy studies. Veolia Biotech will announce the latest research results ...
- Source: drugdu
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- April 10, 2026
【EXPERT Q&A】What standards need to be followed for clinical performance studies under the EU IVDR regulation?

Drugdu.com expert’s response: Under the EU’s In Vitro Diagnostic Regulation (IVDR), clinical performance studies must adhere to the following core standards to ensure the scientific validity, reliability, and compliance of the study results: I. Regulatory Framework and Core Requirements 1. IVDR Regulation (Regulation (EU) 2017/746) Clinical performance studies must comply with the requirements outlined in Articles 57-77 and Annex XIV of the IVDR, covering aspects such as study design, ethical review, subject protection, and data management. It is necessary to demonstrate the scientific validity, analytical performance, and clinical performance of in vitro diagnostic reagents (IVDs), ensuring their association with specific clinical conditions or physiological states. 2. ISO 20916:2024 Standard Core Role: As a harmonized standard under the IVDR, ISO 20916 provides a comprehensive framework for the planning, design, implementation, documentation, and reporting of clinical performance studies. Key Content: Presumption of Conformity: Compliance with the normative clauses of ISO 20916 is ...
- Source: drugdu
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- April 10, 2026
Hologic Acquired for $18.3 Billion, New CEO Joins from Baxter

Hologic, a leader in breast health, in vitro diagnostics, gynecological surgery, and bone health, announced the completion of its go private acquisition led jointly by private equity giants Blackstone and TPG. At the same time, a key management transition was finalized: the company formally appointed José (Joe) E. Almeida, a veteran leader in the medical technology industry, as Chief Executive Officer, effective immediately upon announcement. This management change took place efficiently and in quick succession. Just one day earlier, on April 6, Hologic disclosed that Steve MacMillan, its long serving CEO, would retire upon completion of the privatization transaction. In a single day, this century old healthcare giant completed both its capital restructuring and leadership transition, officially entering a new phase of development. The high profile privatization deal was first agreed in October 2025, when Hologic reached a definitive acquisition agreement with funds managed by Blackstone and TPG. The transaction ...
- Source: drugdu
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- April 9, 2026

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