PharmaFocus Today – Page 10 – media

World’s First! Tianguangshi’s High-Efficacy Drug Approved for Market Launch

On June 9, the NMPA website showed that Tianguangshi MIL62 (generic name: Oxtuzumab β injection ) has been approved for a new indication: the treatment of primary membranous nephropathy (PMN) , becoming the world’s first drug approved for this indication. MIL62 is an innovative third-generation CD20 antibody drug independently developed by Tianguangshi . It was approved for marketing in China in February 2026 for the treatment of neuromyelitis optica spectrum disorder (NMOSD) . It is the world’s first CD20 antibody for the treatment of this disease and also the first domestically produced drug in China in this field. On June 4, 2026, Tianguangshi and Everest Medicines reached a commercialization licensing agreement for the drug and signed a relevant agreement, authorizing the clinical development and commercialization rights of MIL62 in the Asia-Pacific region (Southeast Asia, India, South Korea, Australia, New Zealand, Hong Kong, Macau and Taiwan) . According to the relevant ...
- Source: drugdu
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- June 10, 2026
Another powerful tool has been added to Qilu Pharmaceutical’s arsenal, with another blockbuster drug receiving market approval

Parkinson’s disease is a common neurodegenerative disease that causes great inconvenience to patients’ lives. Especially in the middle and late stages, patients often face severe deterioration of motor function, such as recurrent episodes of muscle stiffness, tremors, and difficulty moving, which greatly reduces their quality of life. On June 9, 2026 , according to the latest information on the official website of the National Medical Products Administration ( NMPA ) of China, salfedipine mesylate tablets , submitted by Qilu Pharmaceutical Co., Ltd. under Category 4 of chemical drug registration , were approved for marketing and are considered to have passed the evaluation. It is mainly used to treat idiopathic Parkinson’s disease in patients who experience motor fluctuations after receiving stable doses of levodopa. Safinamide mesylate tablets are a selective inhibitor of monoamine oxidase type B (MAO-B) with a unique mechanism of action that reduces dopamine degradation and regulates glutamate release, ...
- Source: drugdu
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- June 10, 2026
Huadong Medicine’s application for a change of indication for its Yiyanshi® S-type forehead filler has been accepted, potentially marking another step forward in its high-end regenerative filler business.

On June 9, Huadong Medicine (000963.SZ) announced that its application for a new indication for Ellansé® S – type , an imported Class III medical device injectable polycaprolactone microsphere facial filler , for subcutaneous or suprapeophyte implantation in the forehead to improve moderate to severe forehead contour defects, has been formally accepted by the National Medical Products Administration (NMPA). This application is expected to expand its scope from nasolabial folds to the forehead contour area, strengthening the company’s multi-indication competitive advantage in the PCL regeneration field and enriching its supply of refined facial anti-aging solutions, further releasing the product’s clinical value. Ellansé® is one of the core products of Huadong Medicine Aesthetics , and is known as the ” Youthful Needle” due to its outstanding triple effect of “immediate filling + long-lasting maintenance + natural metabolism”. As the first approved imported PCL high-end facial filler in China, the application for ...
- Source: drugdu
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- June 10, 2026
Inpacpen DCP®, a pen injector made in China, has obtained FDA approval in the United States, ushering in a new era for drug-device combination products going global!

Recently , a strategic partner of Shanghai Newyao Baike Medical Technology Co., Ltd. (Shanghai Newyao Baike Medical Technology Co., Ltd.) received formal approval from the U.S. Food and Drug Administration (FDA) for its Inpacpen DCP® disposable adjustable-dose cartridge injection pen, successfully approved for use in its liraglutide injection! This is the first drug-device combination product approved by the FDA using a pen syringe manufactured in China, marking a historic step for China’s high-end drug delivery devices in entering the international market with the highest regulatory standards. It is also the company’s third product to receive approval in the U.S. market, following the Safetis® needle protector and the InpacJector® Luer pre-filled syringe (COP)!A historic breakthrough in China’s drug-medicine combination products Liraglutide, a blockbuster GLP-1 drug, has long relied on European and American suppliers for its delivery devices. This approval signifies that Chinese-made pen injectors have officially entered the world’s most stringent ...
- Source: drugdu
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- June 10, 2026
Jingfang Pharmaceuticals’ small molecule drug receives Fast Track designation from the US FDA for lung cancer

On June 5th, GenFang Pharmaceuticals announced that GFH375/VS-7375 ( an oral KRAS G12D inhibitor ) received Fast Track Designation (FTD) from the U.S. FDA for the treatment of previously treated patients with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with KRAS G12D mutations (concurrent or sequentially treated with platinum-based chemotherapy and PD-1/PD-L1 inhibitors) . Previously, GFH375/VS-7375 received another Fast Track Designation from the FDA last year for the treatment of first-line and later-line KRAS G12D -mutant metastatic pancreatic ductal adenocarcinoma (PDAC). Furthermore, GFH375 has already received two Breakthrough Therapy Designations (BTD) in China this year for monotherapy in KRAS G12D -mutant advanced pancreatic cancer and NSCLC. GFH375 is an orally administered, highly active, and selective small-molecule KRAS G12D (ON/OFF) inhibitor. It binds to the KRAS G12D protein non-covalently, inhibiting its binding to downstream effector proteins, thereby disrupting the sustained activation of downstream pathways by KRAS G12D in ...
- Source: drugdu
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- June 8, 2026
Once a month! The world’s first new drug for IgA nephropathy has been approved for marketing in China.

Yesterday (June 4), the official website of the National Medical Products Administration (NMPA) showed that Otsuka Pharmaceutical’s application for Sibeprenlimab injection was conditionally approved for marketing, for the treatment of adult patients with primary immunoglobulin A nephropathy (IgAN) to maintain their kidney function. This application had previously been included in the priority review list. Sbelimab is the world’s first approved monoclonal antibody drug targeting the inhibition of proliferation-inducing ligand (APRIL) . Its approval in China marks a new stage in the treatment of IgA nephropathy in China, moving from traditional supportive care to precise intervention targeting upstream causes. 01 IgA nephropathy is highly prevalent and difficult to treat. IgA nephropathy is the most common primary glomerular disease in China, with a patient population of over 2.2 million. The disease is concentrated in young adults aged 16 to 40 and is the leading cause of progression to end-stage renal disease (uremia) ...
- Source: drugdu
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- June 8, 2026
The world’s first Class 1 new drug from a Guangdong pharmaceutical company has been approved for marketing

Mantle cell lymphoma (MCL) combines the highly progressive nature of aggressive lymphoma with the incurable nature of indolent lymphoma. Most patients are diagnosed at an advanced stage, often with involvement of lymph nodes, bone marrow, gastrointestinal tract, and extranodal organs. The successive availability of previous generations of BTK inhibitors has significantly improved patient prognosis, but drug resistance and relapse remain a major challenge to long-term survival. On June 4, 2026, according to the latest information on the official website of the National Medical Products Administration (NMPA) of China, the Class 1 innovative drug lobrutinib tablets submitted by Guangzhou Lupeng Pharmaceutical Co., Ltd. was approved for marketing . The drug is indicated for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least two systemic therapies (including Bruton’s tyrosine kinase [BTK] inhibitors) . According to publicly available information, lobubrutinib is the world’s first fourth-generation covalent ...
- Source: drugdu
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- June 8, 2026
GenSci Pharmaceutical’s self-developed Class 1 new drug has been approved for clinical trials for two indications, covering pediatrics and neurology.

Recently, GenSci155 injection, independently developed by Changchun GenSci Pharmaceutical Co., Ltd. (hereinafter referred to as “GenSci Pharmaceutical”), has been approved by the National Medical Products Administration to conduct clinical trials. It is intended for the prevention of bronchopulmonary dysplasia (BPD) in premature infants and the treatment of acute ischemic stroke (AIS). GenSci Pharmaceutical will subsequently conduct further clinical research in the fields of pediatric health and neuroprotection. GenSci155 injection is a long-acting fatty acid-conjugated recombinant human insulin-like growth factor-1 (IGF-1) analogue, registered as a Class 1 therapeutic biological product. Developed based on GenSci Pharmaceutical’s Duratide™ long-acting sustained-release peptide platform, this product achieves reversible binding to albumin through fatty acid chain modification, prolonging the drug’s half-life in vivo. It supports both intravenous and subcutaneous administration, extending dosing intervals and contributing to stable and adequate drug exposure. Indication 1 Prevention of bronchopulmonary dysplasia (BPD) in premature infants Bronchopulmonary dysplasia (BPD) is the most common pulmonary ...
- Source: drugdu
- 142
- June 8, 2026
Yunnan Baiyao Group’s Central Research Institute’s INB301 injection IND has received FDA clinical trial approval, achieving a milestone breakthrough with “dual applications in China and the United States”

On June 2, 2026, the innovative biological drug INB301 injection, developed by the Central Research Institute of Yunnan Baiyao Group (hereinafter referred to as the “Central Research Institute”), officially obtained Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). Previously, the product had received clinical trial approval from the China National Medical Products Administration (NMPA) on March 30, 2026. The consecutive successful clinical reviews by the drug regulatory agencies of both China and the United States for INB301 injection marks a key advancement for Yunnan Baiyao in its global innovative drug strategy, achieving a significant breakthrough in “dual application” between China and the U.S.Aligning with international standards and setting a new benchmark for Sino-US dual reporting”Dual application in China and the US” is an important indicator of an innovative pharmaceutical company’s R&D strength and its ability to align with international standards. The fact that INB301 injection ...
- Source: drugdu
- 399
- June 8, 2026
Cinda leads the world, and Takeda’s 1.2 billion gamble is reaping the rewards.

On June 4 local time, Innovent Biologics announced that its pivotal Phase III clinical trial of IBI343 (generic name arcotatug tavatecan, Takeda code name TAK-921), a CLDN18.2-targeted ADC drug developed in deep collaboration with Takeda Pharmaceutical, has met its primary endpoint. An arrow incrementally going up stairs before pointing straight up. Blue backgroundMeanwhile, China’s National Medical Products Administration (NMPA) has formally accepted IBI343’s marketing application and included it in the priority review process , making it the world’s first CLDN18.2-targeted ADC to enter the regulatory review stage . Just one year after Takeda acquired the overseas rights to the drug for $1.2 billion last year, Innovent has once again solidified its leading position in the global ADC field with solid clinical data. I. Key results of Phase III clinical trial: Excellent efficacy and manageable safety. The Phase III clinical trial announced this time is an international multicenter study covering China ...
- Source: drugdu
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- June 5, 2026

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