PharmaFocus Today – Page 46 – media

Tangning Tongluo Tablets approved for clinical trials for type 2 diabetes

　　China Securities Intelligent Finance Guizhou Bailing(002424) announced on the evening of October 15 that its wholly-owned subsidiary, Bailing Yuxiu (Zhuhai) Pharmaceutical Co., Ltd., received the “Notice of Approval of Drug Clinical Trial” approved and issued by the National Medical Products Administration (NMPA). The clinical trial application for Tangning Tongluo Tablets submitted by Bailing Yuxiu was approved, and it was agreed that this product would be used for clinical trials in type 2 diabetes. 　　The announcement indicates that this product, which received clinical trial approval in 2024 for non-proliferative diabetic retinopathy (yin deficiency, internal heat, and eye meridian stasis), is currently applying to add an indication for type 2 diabetes (damp-heat accumulation syndrome) during clinical trials. The information states that Tangning Tongluo Tablets were prepared by a medical institution in Guizhou Province, and summary reports from three previous clinical studies have been provided. This Phase II clinical trial will fully explore ...
- Source: drugdu
- 234
- October 16, 2025
TQ-B3234 Capsules, a “selective MEK1/2 inhibitor,” receives Breakthrough Therapy Designation

On October 15, Sino Biopharmaceutical (01177) issued an announcement, announcing that the national Class 1 new drug TQ-B3234 capsules, a “selective MEK1/2 inhibitor” developed by it, has been included in the breakthrough therapy drug program by the Drug Review Center of the China National Medical Products Administration for the treatment of symptomatic, inoperable neurofibromatosis type 1 (NF1)-related adult plexiform neurofibromas. According to Phase I clinical trial results presented at the 2025 American Society of Clinical Oncology Annual Meeting, TQ-B3234 demonstrated significant activity against NF1-related plexiform neurofibromas, with 96.7% of NF1-PN subjects experiencing tumor shrinkage and 36.7% achieving partial remission. In an exploratory analysis, 100% of cNF patients experienced tumor shrinkage, with the largest reduction reaching 85.2%. https://finance.eastmoney.com/a/202510153535018717.html
- Source: drugdu
- 124
- October 16, 2025
Novo Nordisk and Omeros reach asset purchase and licensing agreement for zaltinibart

On October 15, Novo NordiskNovo Nordisk and Omeros announced a definitive asset purchase and license agreement for zaltinibart (OMS906), a clinical-stage drug candidate for the treatment of rare blood and kidney diseases. Under the terms of the agreement, Novo Nordisk will obtain exclusive development and commercialization rights for zaltinibart for all indications worldwide. Omeros is eligible to receive an upfront payment of US$340 million and near-term milestone payments, with a total of up to US$2.1 billion including potential development and commercial milestones, plus tiered royalties based on net sales. The transaction is expected to close in the fourth quarter of 2025. https://finance.eastmoney.com/a/202510153535182876.html
- Source: drugdu
- 119
- October 16, 2025
New insights into MDMA therapy for PTSD and beyond

A comprehensive peer-reviewed invited review published today in Psychedelics by Dr. Kenji Hashimoto and colleagues (Dr. Mingming Zhao and Dr. Jianjun Yang) synthesizes the evolving landscape of MDMA-assisted psychotherapy, examining robust clinical evidence in treatment-resistant posttraumatic stress disorder while identifying promising applications in autism spectrum disorder, eating disorders, and existential distress. The review traces the complex journey from early therapeutic promise through prohibition to current regulatory challenges, providing critical analysis of safety profiles and novel resilience mechanisms mediated by the gut-brain axis. Bridging seven decades of research The review encompasses MDMA research spanning from its 1912 synthesis at Merck through contemporary Phase III clinical trials. Dr. Hashimoto and colleagues systematically analyze how this distinctive entactogen reverses the serotonin transporter to massively increase synaptic serotonin while simultaneously engaging oxytocin and catecholaminergic pathways. The authors examine 126 primary sources to construct a comprehensive narrative of how MDMA produces its unique prosocial and ...
- Source: drugdu
- 151
- October 15, 2025
Fentanyl-Linked Overdose Deaths Among Seniors Soar 9,000% in 8 Years

By Dennis Thompson HealthDay ReporterTUESDAY, Oct. 14, 2025 (HealthDay News) — Fentanyl overdose deaths are surging among seniors, particularly in cases where the powerful opioid is mixed with stimulants like cocaine or methamphetamine, a new study says. Fentanyl-stimulant overdose (OD) deaths skyrocketed by an astonishing 9,000% during the past eight years, approaching rates found in younger adults, researchers reported Saturday at an American Society of Anesthesiologists’ meeting in San Antonio, Texas. “A common misconception is that opioid overdoses primarily affect younger people,” lead researcher Gab Pasia, a medical student at the University of Nevada-Reno School of Medicine, said in a news release. “Our analysis shows that older adults are also impacted by fentanyl-related deaths and that stimulant involvement has become much more common in this group,” Pasia said. “This suggests older adults are affected by the current fourth wave of the opioid crisis, following similar patterns seen in younger populations.” ...
- Source: drugdu
- 96
- October 15, 2025
Clover Biopharmaceuticals’ Phase I clinical data for its respiratory combination vaccine and RSV vaccine are positive.

　　On October 14, Clover Biopharmaceuticals (02197) announced positive data from Phase I clinical trials of its respiratory combination vaccine (RSV-hMPV-PIV3) and repeat RSV vaccine in the elderly population. Both Phase I clinical trials in Australia and the United States demonstrated favorable safety and immune responses. 　　Specifically, in the Australian trial, the mean doubling rates of RSV neutralizing antibodies induced by SCB-1022 (RSV+hMPV) and SCB-1033 (RSV+hMPV+PIV3) were approximately 6-8 times, and the mean doubling rates of hMPV-A and hMPV-B neutralizing antibodies were 6-7 times and 8-9 times, respectively. 　　In repeat vaccination trials in the United States, heterologous repeat vaccinations of SCB-1019 (an RSV vaccine candidate) resulted in a mean RSV neutralizing antibody doubling rate of approximately 3.0-3.3 times. In contrast, homologous repeat vaccinations of AREXVY only boosted antibody levels to approximately 60-65% of the peak levels induced after the first dose. The company plans to advance SCB-1022 and SCB-1033 into Phase ...
- Source: drugdu
- 108
- October 15, 2025
Ascletis Pharmaceuticals initiates clinical development of ASC35, leveraging AI and platform technologies to develop an ultra-long-acting dual-target weight loss drug.

On October 13, Ascletis Pharma (01672) announced that its GLP-1R/GIPR dual-target agonist peptide, ASC35, has entered clinical development. In a head-to-head non-human primate study, the drug demonstrated a mean apparent half-life of approximately 14 days, six times longer than tilpotide, supporting once-monthly subcutaneous administration. ASC35’s drug exposure after intravenous and subcutaneous injection is approximately 80% and 70% higher than that of tilpotide, respectively. Furthermore, ASC35’s agonist activity at GLP-1 and GIP receptors is approximately four times stronger than that of tilpotide. In a study of diet-induced obese mice, ASC35 achieved a 33.6% weight loss effect, compared to 19.6% for tilpotide, representing a relative improvement of approximately 71% in weight loss. The company expects to submit a new drug clinical trial application for ASC35 to the U.S. Food and Drug Administration in the second quarter of 2026. The announcement mentioned that ASC35 was independently developed based on the company’s AI-assisted drug ...
- Source: drugdu
- 124
- October 15, 2025
Hengrui Medicine’s multiple injectable drugs received approval for clinical trials

Beijing Business News reported on October 13 that Hengrui MedicineThe company announced that its subsidiaries, Suzhou Shengdia Biopharmaceutical Co., Ltd., Shanghai Hengrui Medicine Co., Ltd., and Shanghai Shengdi Pharmaceutical Co., Ltd., have received approval from the National Medical Products Administration for the issuance of “Drug Clinical Trial Approval Notices” for SHR-A2102 for injection, Adebelimumab injection, and SHR-1802 for injection. Clinical trials will commence soon. This will be a multicenter, open-label Phase IB/II study investigating the safety, tolerability, and efficacy of SHR-A2102 for injection, combined with Adebelimumab and SHR-1802, in subjects with advanced solid tumors. The announcement shows that SHR-A2102 for injection is independently developed by the company and has intellectual property rights.The company’s nectin-4-targeting antibody-drug conjugate (ADC) contains a topoisomerase I inhibitor (TOP1i) as its payload. SHR-1802 for injection is a humanized monoclonal antibody independently developed by the company that activates and promotes anti-tumor T cell responses, exerting anti-tumor effects. ...
- Source: drugdu
- 172
- October 15, 2025
Kelun Biotech’s ADC wins a major indication

Recently, Kelun Biotech announced that its TROP2-targeted ADC drug sac-TMT (sac-TMT, R&D code SKB264/MK-2870) was approved by the NMPA for a third indication for the treatment of adult patients with EGFR-positive non-squamous non-small cell lung cancer (NSCLC) that progressed after EGFR-TKI treatment. Lung cancer is the number one malignant tumor in my country. Its pathological classification mainly includes non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). NSCLC is the most common pathological type, accounting for approximately 80%-85% of all lung cancer patients. EGFR mutations are the most common tumor-driving gene mutations in lung cancer. First-line treatment is primarily with third-generation EGFR-TKI targeted therapy, but patients inevitably develop drug resistance after receiving this type of therapy. Treatment options for EGFR-TKI resistance are very limited, and platinum-based doublet chemotherapy is currently the primary standard of care. However, these treatment options are suboptimal, particularly in extending overall patient survival. This ...
- Source: drugdu
- 172
- October 14, 2025
New drug TQB2102 is included in the breakthrough therapy program

On October 13, Sino Biopharmaceutical (01177) announced that its independently developed Class 1 new drug TQB2102 for injection, a HER2 bispecific antibody-drug conjugate (ADC), has been included in the Breakthrough Therapy Program by the Center for Drug Evaluation of the China National Medical Products Administration for the treatment of HER2 IHC 3+ advanced colorectal cancer that has failed prior treatment with oxaliplatin, irinotecan, or fluorouracil. https://finance.eastmoney.com/a/202510133532526140.html
- Source: drugdu
- 126
- October 14, 2025

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