PharmaFocus Today – media

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
- 51
- 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
- 46
- 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
- 44
- 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
- 41
- 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
- 43
- 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
- 62
- June 5, 2026
The National Medical Products Administration (NMPA) conditionally approved the marketing of Pometamethasone Alpha for injection.

Recently, the National Medical Products Administration (NMPA) conditionally approved the marketing of Pometrazyne Alpha for Injection (trade name: Bojia Ning) submitted by Jiangsu Bejitech Biotechnology Co., Ltd. through the priority review and approval procedure. It is indicated for the treatment of bleeding in adult patients with congenital hemophilia A or B who have an inhibitor of coagulation factor VIII or IX >5 Bethesda units (BU). The marketing of this product provides a new treatment option for these patients . https://mp.weixin.qq.com/s/Y059ZMm7OwCt2Y6y9d5Aqw
- Source: drugdu
- 59
- June 5, 2026
The generic version of this drug, developed by 35 pharmaceutical companies, has had its market launch delayed by 5 years.

Just as the 12th batch of centralized procurement was launched, Noxinto (sacubitril/valsartan sodium tablets), the “king of drugs” in the cardiovascular field , was unexpectedly thrust into the spotlight. Just as the industry widely predicted that this blockbuster original drug, with annual sales reaching billions of yuan, would be included in the centralized procurement, a decision by the State Intellectual Property Office to extend its core patent for five years instantly changed market expectations. Recently, the State Intellectual Property Office officially issued a decision on the patent term extension for Novartis’ sacubitril/valsartan sodium tablets (Noxinto) patent 200680001733.0. After review, the decision was made to grant the patent a 1826-day extension period , extending the expiration date of one of its core crystal form patents, originally scheduled for November 8, 2026, to November 8, 2031. 35 domestic companies have obtained approval for generic versions of sacubitril/valsartan sodium tablets . Amid the ...
- Source: drugdu
- 61
- June 5, 2026
Pharmaceutical giant lays off more employees

According to foreign media reports, Merck, a global pharmaceutical giant , has filed a new Worker Adjustment and Retraining Notification Act (DRM) document with the New Jersey state government, indicating that the company will lay off 88 employees at its global headquarters in Rowe, New Jersey . The personnel changes are scheduled to take effect in September 2026. This round of layoffs of 88 people is a microcosm of Merck’s broader strategic restructuring. In July 2025, Merck officially disclosed in its second-quarter financial report that it had launched a comprehensive cost-cutting plan with the goal of saving $3 billion annually by the end of 2027 , and reinvesting these savings to support the launch of new products. Behind the layoffs lies two structural pressures facing Merck. First, the patent protection for its blockbuster drug Keytruda is about to expire . This “king of drugs” contributed approximately $31.7 billion in sales ...
- Source: drugdu
- 62
- June 5, 2026
Imported “new kidney disease drug” approved

Today (June 4th), the official website of the National Medical Products Administration (NMPA) shows that Otsuka Pharmaceutical’s sipelimab injection (Izaike) has been officially approved for marketing, with the indication being adult patients with primary immunoglobulin A nephropathy (IgAN). This is the first monoclonal antibody targeting the proliferation-inducing ligand (APRIL) to be approved in China and the world. IgA nephropathy is the most common primary glomerular disease worldwide and one of the leading causes of chronic kidney disease and end-stage renal disease (ESKD) in China. It commonly affects people aged 20-40, and some patients may progress to end-stage renal disease several years after diagnosis, highlighting the urgent need for innovative therapies to slow the deterioration of kidney function. Sipelimab was acquired by Otsuka Pharmaceutical in 2018 through its acquisition of Vistara for $430 million. Its mechanism of action targets the core aspects of the pathogenesis of IgA nephropathy. In the pathological ...
- Source: drugdu
- 62
- June 5, 2026

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