PharmaFocus Today – Page 3 – media

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
- 76
- 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
- 97
- 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
- 83
- 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
- 89
- 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
- 160
- 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
- 124
- 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
- 148
- June 5, 2026
A breakthrough for domestically produced IOLs! Another innovative device approved for market launch

Recently, the National Medical Products Administration approved the registration application of the trifocal intraocular lens of Henan Saimei Vision Biotechnology Co., Ltd. (hereinafter referred to as Saimei Vision), marking a new breakthrough for domestic high-end IOLs. 01 Sino-US joint venture Focus on the research and development of high-end ophthalmic implant devices Established in 2018, CEMIVIS is a Sino-US joint venture controlled by Shanghai Haohai Biological Technology Co., Ltd. and THERAMEDICELLC. Since its inception, it has focused on the research and development and production of high-end ophthalmic implantable devices. According to CEMIVIS’ official website, its product pipeline is divided into two main categories: intraocular lenses and equipment/instruments , with a total of 7 products in the intraocular lens category . According to data from Yaozhi Medical Devices, SEM currently has five products on the market in China (excluding the products launched this time shown in the image below), all of which ...
- Source: drugdu
- 78
- June 5, 2026
A leading traditional Chinese medicine company’s Class 1 biological drug has received IND approval in the United States.

Recently, Yunnan Baiyao issued an announcement stating that its Investigational New Drug (IND) application for INB301 injection has been approved by the U.S. FDA, which agrees to conduct clinical trials for the intended indication of tumor cachexia. The press release states that this is the company’s first innovative therapeutic biological drug. Cancer cachexia is a complex metabolic disorder syndrome caused by malignant tumors, characterized by persistent skeletal muscle wasting that is difficult to reverse with conventional nutritional support. Previously, the IND for INB301 injection was included in the 30-day fast track for innovative drug review and approval in China, and was approved by the NMPA in March 2026. To date, the drug has obtained clinical trial approvals in both China and the United States, with a total R&D investment of approximately RMB 50.665 million. As a leading Chinese medicine enterprise, Yunnan Baiyao has been accelerating the research and development of ...
- Source: drugdu
- 74
- June 5, 2026
The world’s second inhaled insulin has been approved for a new indication.

In the field of diabetes treatment, the exploration of non-injectable drug delivery routes has never stopped. Recently, the U.S. FDA officially approved the expanded pediatric indication for inhaled insulin Afrezza , making it the first and only mealtime inhaled insulin approved for use in children and adolescents aged 6 years and older. As the second inhaled insulin approved for marketing globally after Exubera, Afrezza’s successful entry into the pediatric nursing field not only fills the market gap for needle-free blood sugar control in children, but also marks a milestone in pediatric endocrine therapy. 01 Inhaled insulin can be used for children aged 6 years and older. The approval of Afrezza’s new indication makes it the world’s first non-invasive insulin for pediatric use in nearly a century , reshaping the landscape of injectable insulin administration for adolescent diabetes. This drug is rapidly absorbed through the alveoli and takes effect by mimicking ...
- Source: drugdu
- 70
- June 5, 2026

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