PharmaFocus Today – Page 2 – media

Gan & Lee Pharmaceuticals’ Aspart Insulin 30 Injection Approved in India, Breaking Long-Term Monopoly of Original Drug Manufacturers

Recently, Gan & Lee Pharmaceuticals (stock code: 603087.SH) announced that its Aspart Insulin 30 Injection has officially obtained import marketing authorization from the Central Drugs Standard Control Organisation (CDSCO) of India, becoming the first approved biosimilar of Aspart Insulin 30 Injection in India. Breaking the monopoly of original research drugs and solving the problem of accessibility to diabetes diagnosis and treatment in India. India has one of the largest diabetes populations in the world. According to the latest data from the International Diabetes Federation (IDF), there are approximately 89.83 million people aged 20-79 with diabetes in India, a number projected to rise to 157 million by 2050, representing a growth rate of 75% .<sup> 1 </sup> With the continued growth of the local diabetes population, the market demand for high-quality, readily available insulin products is increasingly urgent. However, the supply of aspart insulin 30 injection in India has long relied ...
- Source: drugdu
- 60
- July 27, 2026
Paliperidone Palmate Injection from CSPC Pharmaceutical Group Approved for Marketing

On July 24, CSPC Pharmaceutical Group (1093.HK) announced that its independently developed second-generation antipsychotic long-acting injection, paliperidone palmitate injection (specifications include: (1) 0.75ml:75mg; (2) 1.0ml:100mg; (3) 1.5ml:150mg (calculated as C 23 H 27 FN 4 O 3 ) (hereinafter referred to as “the product”), has been approved for marketing by the National Medical Products Administration of the People’s Republic of China and is suitable for the treatment of acute and maintenance phases of schizophrenia. Compared to traditional antipsychotic drugs, this product only needs to be administered once a month, and it takes effect quickly after administration, requiring no oral medication supplementation. It can be used to treat patients in the acute phase. At the same time, monthly administration significantly improves patient medication adherence, avoids missed doses, and effectively reduces the relapse rate and readmission rate. This product is listed as a recommended medication in authoritative domestic and international treatment guidelines ...
- Source: drugdu
- 56
- July 27, 2026
FDA approves first ophthalmic bevacizumab for market.

On July 24, Outlook Therapeutics announced that ONS-5010 (bevacizumab, brand name: Lytenava) received FDA approval for the treatment of wet age-related macular degeneration (wAMD). This is the first ophthalmic bevacizumab formulation approved by the FDA. The original bevacizumab ( Avastin ) is an anti-VEGF-A monoclonal antibody developed by Roche and is currently only indicated for cancer patients. ONS-5010 has completed four Phase III studies to date, including NORSE ONE, NORSE TWO, NORSE THREE, and NORSE EIGHT . NORSE ONE was a proof-of-concept study that included 61 patients with wAMD. The results showed that the proportion of patients in the ONS-5010 group who achieved an increase of more than 15 letters in their best corrected visual acuity (BCVA) score was not significantly different from that in the ranibizumab group (11.8% vs. 22%).The NORSE TWO study included 228 patients with wAMD. Results showed that the proportion of patients achieving an increase of ...
- Source: drugdu
- 57
- July 27, 2026
Chinese innovative drugs score a Blockbuster Deal! AstraZeneca buys out Suvolotinib for $1.5 billion

Originally produced by Yang Xixia, Jianshi Bureau, July 14, 2026 20:24 Beijing On July 14, China’s innovative drug industry saw another major deal: ج Dizal Pharma willgrant AstraZeneca the exclusive global development and commercialization rights to suvolotinib. AstraZeneca will pay Dizal Pharma a $600 million upfront payment and $900 million in milestone payments, with clinical development and sales milestones capped at $400 million and $500 million, respectively. Simply put, AstraZenecabought out suvolotinib outright for $1.5 billion. As soon as the news broke, Dizal Pharma’s stock surged 20CM in the afternoon. The capital market recognized the certainty of this deal. Unlike other BD deals that often run into the billions of dollars, Dizhe’s $1.5 billion total may not be large, but the $600 million upfront payment is real cash in hand, and the future milestone payments are also highly certain. This is the fundamental reason the market is willing to pay ...
- Source: drugdu
- 103
- July 15, 2026
【Company Recommendation】Shanghai Wantewant Technology Co., Ltd

Company Profile We are a high-tech enterprise oriented towards research and development, specializing in the fields of pharmaceutical raw materials, intermediates, peptide components, cosmetic raw materials, and nutritional supplement raw materials. We offer standardized large-scale production services and conduct global wholesale business. Our multiple peptide raw materials possess core physiological effects such as weight loss, muscle building, blood sugar reduction, and anti-aging, are widely applicable to the research and production demands in the pharmaceutical, beauty, and health care sectors. We adopt strict batch production standards and have sufficient production capacity and stable supply capabilities. All products have been professionally tested by third-party institutions and come with complete test reports and qualification certificates, ensuring stable batch quality and complete traceability. For large-scale orders, we offer competitive wholesale prices. We uphold the core values of integrity, pragmatism, innovation and development, and continuously enhance our technical strength and product quality. Product Introduction We ...
- Source: drugdu
- 113
- July 10, 2026
Ascletis Pharma submits Investigational New Drug (IND) applications to the FDA for two new obesity drugs

Recently, Ascletis Pharma announced that it has recently submitted two Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA): ASC36, a next-generation peptide amylin receptor agonist administered once monthly to quarterly, and ASC36_35FDC, a once-monthly injectable combination of ASC36 and the peptide GLP-1R/GIPR agonist ASC35, for the treatment of obesity. According to relevant data, the overweight rate among adults in my country is about 34.3%, and the obesity rate is about 16.4%; the overweight rate among children and adolescents aged 6 to 17 is 11.1%, and the obesity rate is 7.9%, indicating that the overall situation is still not optimistic. https://mp.weixin.qq.com/s/Vt-YLF5ncLZAxzwrngG75A
- Source: drugdu
- 117
- July 9, 2026
Fengtou News | Highlight Pharmaceuticals’ Ganoxitinib Receives Breakthrough Therapy Designation from CDE

Today, Glorious Pharmaceuticals announced that its independently developed oral highly selective JAK1/TYK2 dual inhibitor, ganoxitinib (TLL-018), has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration for the treatment of rheumatoid arthritis (RA). This designation is based on positive topline data from the Ganoxitinib Phase III Registration Study (TARA). The CDE (Center for Drug Evaluation) has determined that Ganoxitinib meets the criteria for breakthrough therapy, indicating its use in the prevention and treatment of life-threatening or quality-of-life diseases, and demonstrating a more significant or important therapeutic effect compared to existing treatments. The TARA study is the world’s first Phase III clinical trial of RA using the marketed JAK inhibitor Shangjie® (tofacitinib) as a positive control and achieving the superiority endpoint. Data showed that ganoxitinib was significantly superior to tofacitinib in both the primary endpoint and all secondary efficacy endpoints (p ...
- Source: drugdu
- 119
- July 9, 2026
【Company Recommendation】Emeishan Hongsen Biopharmaceutical Co., Ltd.

Company Introduction Emeishan Hongsen Biopharmaceutical Co., Ltd. is a national high-tech enterprise focusing on peptide fragments, protected amino acids, pharmaceutical intermediates, APIs, and CMO/CDMO fields. Business scope: an experienced project undertaking team escorts full life-cycle CMO/CDMO services; a GMP quality system that has been audited many times by domestic and foreign customers; the company has an independent technology R&D center, a provincial enterprise technology center, and Leshan Synthetic Biology Engineering Technology Research Center, providing one-stop services including process optimization, R&D, production, and sales. The company was established on February 18, 2011. It currently has more than 150 employees and more than 70 sets of various reactors ranging from 100L to 6300L, providing flexible and diversified cooperation models. Star Products 89030-95-5 Copper Peptide Copper peptide can effectively stimulate the biosynthesis of collagen in fibroblasts, thereby promoting rapid wound healing. It can also effectively block the neurotransmission of acetylcholine substances, thereby relaxing ...
- Source: drugdu
- 152
- June 26, 2026
China’s first ADC (Advanced Dioxide Doppler) to be submitted for market approval

On June 23, the CDE (Center for Drug Evaluation) website showed that Chia Tai Tianqing Pharmaceutical Group’s application for marketing authorization of vetectobactimab for injection was accepted. This monotherapy is indicated for patients with CLDN18.2-positive, locally advanced, or metastatic gastric/gastroesophageal junction adenocarcinoma who have received at least two lines of prior systemic therapy . Previously, this drug had been formally included in the CDE’s priority review and approval process . Screenshot source: CDE official website Vitacotobactam (development code: LM-302 ) is an antibody-drug conjugate (ADC) targeting Claudin18.2 (CLDN18.2) developed by Lixin Pharmaceuticals. It specifically binds to CLDN18.2-positive tumor cells, enters the cells via endocytosis, and releases small molecule toxins to achieve precise killing of tumor cells. In July 2025, China Biopharmaceutical announced that it would acquire 100% of Lixin Pharmaceutical Technology (Shanghai) Co., Ltd. for a net consideration of approximately US$500 million , bringing the latter’s highly regarded bispecific antibody ...
- Source: drugdu
- 147
- June 25, 2026
Sanofi’s second autoimmune BTK inhibitor approved for marketing

On June 23, Sanofi announced that Tolebrutinib (trade name: Cenrifki) has been approved by the European Medicines Agency (EMA) for the treatment of relapse-free secondary progressive multiple sclerosis (SPMS). This drug is the first approved treatment for non-relapsing SPMS and Sanofi’s second approved autoimmune BTK inhibitor. Sanofi’s first autoimmune BTK inhibitor, Rilzabrutinib (trade name: Wayrilz ), was approved in the US and Europe in 2025.This approval was supported by the Phase III HERCULES study , which included 1131 patients with non-recurrent SPMS .Patients. Results showed that at a median follow-up of 133 weeks, the proportion of patients in the Tolebrutinib (60 mg, once daily) group who had confirmeddisability progression lasting at least 6 months was significantly lower than that inthe placebo group (22.6% vs 30.7%, HR=0.69, P=0.003).Multiple sclerosis (MS) is a chronic, immune-mediated neurodegenerative disease of the central nervous system that can lead to persistent and irreversible disability over time. ...
- Source: drugdu
- 132
- June 25, 2026

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