PharmaFocus Today – Page 4 – media

A powerful alliance! High-end endoscopic ultrasound system approved for market launch

According to recent foreign media reports, Olympus and Canon Medical have jointly announced the official launch of the Aplio i800 EUS high-end endoscopic ultrasound system in the US market.In 2024, Olympus and Canon Medical announced a partnership on endoscopic ultrasound (EUS) technology. This collaboration, centered on the Aplio i800, aims to provide the market with advanced endoscopic ultrasound equipment to facilitate high-quality image diagnosis. The Aplio i800 EUS is manufactured by Canon and exclusively distributed by Olympus. The addition of this system further enriches Olympus’ comprehensive portfolio of endoscopes and endoscopic therapeutic instruments. This system supports high-quality imaging in a wide range of endoscopic ultrasound procedures and provides reliable data for clinical evaluation. Canon’s ultrasound platform features imaging technology that helps diagnose lesions in the liver, gallbladder, and pancreas, including liver and pancreatic diseases that are difficult to diagnose due to their complex anatomical location. The Aplio i800’s flexible design ...
- Source: drugdu
- 69
- April 13, 2026
BeiGene’s DLL3/CD3 dual antibody approved for marketing in China

Recently, BeiGene officially announced that its DLL3/CD3 bispecific antibody talatumab, developed in collaboration with Amgen, has been approved for marketing in China for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have failed at least two lines of prior therapy (including platinum-based chemotherapy). Talatumab is a bispecific TCE antibody that targets DLL3 and CD3. It employs a novel cell adaptor structure design that can bind to DLL3 expressed on the surface of cells (including tumor cells) and CD3 expressed on the surface of T cells, causing T cell activation, release of inflammatory cytokines, and lysis of DLL3-expressing cells. SCLC is a highly aggressive and destructive malignant tumor, accounting for approximately 15% of all lung cancer cases worldwide . About 70% of SCLC patients are further diagnosed with ES-SCLC . In China, there are approximately 160,000 new cases of SCLC annually . This disease is characterized ...
- Source: drugdu
- 58
- April 13, 2026
The world’s first Roche blockbuster new drug to be submitted for marketing approval for a new indication.

Lupus nephritis is one of the most common and serious complications of systemic lupus erythematosus (SLE). Approximately 40%-60% of SLE patients will experience kidney involvement. If poorly controlled, about 20% of patients will progress to end-stage renal disease within 10 years, requiring dialysis or kidney transplantation, which seriously affects the patient’s quality of life and survival. On April 10, 2026, according to the latest information on the website of the Center for Drug Evaluation (CDE) of China , Roche Pharma ‘s application for a new indication for its oxotuzumab injection, submitted under category 3.1 of therapeutic biological products, has been accepted. Based on publicly available information and clinical trial progress, it is speculated that the new indication applied for is active lupus nephritis (LN) . This means that this anti-CD20 monoclonal antibody, the world’s first to be approved for this indication, has officially begun the approval process for marketing in ...
- Source: drugdu
- 63
- April 13, 2026
First! Generic Smegglutide Receives Provisional Approval from FDA

On April 10, Apotex announced that its Abbreviated New Drug Application (ANDA) for a generic version of Ozempic ( semaglutide injection ) received the first tentative approval from the U.S. FDA . Apotex’s semaglutide injection was developed through a strategic partnership with Orbicular Pharmaceutical Technologies . Dr. MS Mohan, Managing Director of Orbicular, stated, ” Achieving technical equivalence for complex peptide products requires deep scientific rigor, advanced analytical precision, and highly standardized development methodologies. We are proud to support Apotex in advancing this important project. Their regulatory leadership, combined with Orbicular’s development and execution excellence, were key elements in securing FDA provisional approval. “ Barry Fishman, Chief Corporate Development Officer at Apotex, stated, “ This is powerful proof of what a true partnership can achieve. As a health advocate, this milestone demonstrates Apotex’s leadership in leveraging complementary strengths, sharing a mission, and relentlessly pursuing excellence. ” Once final approval is ...
- Source: drugdu
- 65
- April 13, 2026
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
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- 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
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- 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
- 73
- 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
- 75
- 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
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- April 10, 2026

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