The field of diabetes drugs is undoubtedly dominated by peptide molecules, but recently an oral small molecule diabetes pipeline drug inspired by traditional Chinese medicine has shown great promise in a head-to-head trial against MNC’s blockbuster drug dapagliflozin. 01 Head-to-head 3-round success Recently, Junshengtai Pharmaceutical ‘s Phase 3 diabetes pipeline asset, HTD1801, has yielded remarkable results in three Phase 3 clinical trials. The latest published result is from the HARMONY trial, a randomized, double-blind, actively controlled Phase 3 study conducted in China. It enrolled 369 adult patients with type 2 diabetes whose condition was not adequately controlled by metformin, comparing HTD1801 with AstraZeneca’s SGLT2 inhibitor dapagliflozin in terms of HbA1c changes at 24 weeks, with a non-inferiority margin set at 0.4%. The results showed that, while maintaining a stable metformin dose, the mean least squares HbA1c level at week 24 decreased by 1.12% from baseline in the HTD1801 group and ...
Shenzhen Hongxin Biotechnology Co., Ltd. recently underwent industrial and commercial registration changes, adding Guangxi Tencent Venture Capital Co., Ltd. and others as shareholders, while its registered capital increased to 2.55739 million yuan. Qichacha information shows that the company was established in 2021, and its business scope includes: biomass energy technology services; medical research and experimental development; cell technology research and application, etc. According to its official website, Hongxin Biotechnology is an RNA innovative drug company.Research and development company. https://finance.eastmoney.com/a/202512113588542497.html
Juncell Therapeutics has submitted a listing application to the Hong Kong Stock Exchange, with CITIC Securities acting as its exclusive sponsor. Juncell Therapeutics is a biotechnology company dedicated to developing innovative cell therapies and novel drugs for solid tumors, focusing on creating immune cell therapies that are safer, more effective, more accessible, and more affordable. The company’s core product, GC101, is the world’s first tumor-infiltrating lymphocyte (TIL) therapy that does not require high-intensity lymphodepleting chemotherapy or IL-2 administration. It is expected to become the first TIL therapy approved for marketing in China. As a single-dose treatment, TIL cell therapy has the potential to deliver curative outcomes for certain patients with advanced tumors. Clinical data show that TIL therapy also provides long-term benefits to patients with various types of solid tumors, including advanced melanoma, non-small cell lung cancer (NSCLC), and breast cancer. In Phase I clinical trials for advanced metastatic solid ...
Shanghai Securities News, China Securities Network – Chongqing Pharmaceutical Holdings announced on the evening of December 10 that its investee subsidiary, Chongqing Yaoyou Pharmaceutical Co., Ltd. (referred to as “Yaoyou Pharmaceutical”), together with Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd., signed a Collaboration and License Agreement (referred to as the “License Agreement”) with Pfizer on December 9. Under the agreement, Yaoyou Pharmaceutical grants Pfizer exclusive rights for the development, use, production, and commercialization of oral small-molecule glucagon-like peptide-1 receptor (GLP-1R) agonists (including YP05002) and products containing this active ingredient within the licensed territory (i.e., globally) and field (covering treatment, diagnosis, and prevention for all human and animal indications). For this license, Yaoyou Pharmaceutical is entitled to receive a non-refundable upfront payment of $150 million and up to $350 million in development milestone payments based on the clinical and commercial progress of the licensed product. It is reported that YP05002 is ...
On December 10, TopAlliance Biosciences, in answering an investor question on an interactive platform, stated that the company has obtained approval for a Phase I/II clinical trial of combined use of JS207 (PD-1/VEGF bispecific antibody) and JS212 (EGFR/HER3 bispecific ADC), and plans to launch related clinical studies in the near future. JS207 is currently in the Phase II clinical study stage. Combination explorations are underway in multiple tumor types, combining JS207 with various drugs such as chemotherapy, monoclonal antibodies, and ADCs. The company will actively explore a variety of combination regimens to maximize the synergistic effect of its pipeline. It is noted that due to the early-stage research and development of pharmaceutical products and the lengthy, multi-stage cycle from R&D and clinical trial application to production, they are susceptible to various uncertainties. https://finance.eastmoney.com/a/202512103587875995.html
Li Li, Secretary of the Party Leadership Group and Director of the National Medical Products Administration (NMPA), stated in an interview that pharmaceutical regulation work is closely related to people’s livelihoods. During the 15th Five-Year Plan period, pharmaceutical regulation will consistently regard enhancing the public’s sense of gain, happiness, and security as its fundamental starting point and ultimate goal. The aim is to ensure that the achievements of reform and development benefit the entire population more extensively and fairly, and to continuously meet the people’s aspirations for a better life and their needs for health protection. The NMPA will make full use of accelerated pathways, such as breakthrough therapy designation, conditional approval, priority review and approval, and special approval procedures. This will expedite the review and approval of urgently needed overseas new drugs, rare disease drugs, and pediatric medicines, shortening the distance from laboratory to bedside and allowing innovative achievements ...
Organiser:Informa Time: June 2nd – 4th, 2026 Address:10 Dr Nurudeen Olowopopo Way, Agidingbi, Ikeja Exhibition hall:Lagos International Conference and Exhibition Center Product range: Medical Devices: Blood pressure monitors, microscopes, audiometers, X-ray machines, CT scanners, magnetic resonance imaging (MRI) machines, B-ultrasound machines, biochemical analyzers, electrocardiographs, laser therapy machines, ventilators, blood bank equipment, medical video and photography equipment, medical aesthetic equipment, orthopedic equipment, etc. Medical Consumables: Surgical, emergency room, and consultation room instruments; surgical gowns, shoes, and gloves; various medical surgical knives, forceps, scissors; disposable items; test tubes; band-aids; masks; bandages; stethoscopes; toolkits; work uniforms; syringes, etc. Rehabilitation Products: Orthotic devices, walkers, massagers, health beds, medical beds, medical bathtubs, crutches, wheelchairs, health-care apparel, fitness equipment Health Care Products: Home health care products, small-sized home diagnostic, monitoring, and treatment instruments; rehabilitation and physiotherapy instruments and supplies; oral and dental health care products and related items; health care devices, etc. Laboratory Equipment: Laboratory utensils, various reagents, test papers, test ...
As global pharmaceutical markets place increasing demands on the variety, quality and compliance of excipients, more and more excipient manufacturers are looking to move beyond their domestic markets and enter the international arena. However, the reality often looks like this: Overseas customers simply cannot find you Building your own international sales team is costly and time-consuming Lack of experience in registration and professional presentation makes it hard to build trust This article focuses on how excipient manufacturers can leverage B2B platforms to expand globally, and aims to provide small and medium-sized companies with a practical, repeatable and cost-controllable approach. I. Typical Challenges for Excipient Manufacturers Going Global 1. Single-channel dependence: heavily reliant on offline and personal networks Most companies still rely on a traditional mix of: “Domestic pharma exhibitions + trading companies + personal connections” This model is low in efficiency and makes it difficult to build a scalable and ...
Drugdu.com expert’s response: Pharmaceutical products need to obtain four major types of certifications based on the regulatory requirements of the target markets for export: quality management system certification, regional market access certification, production specification certification, and special product-specific certifications, as detailed below: I. Quality Management System Certification (Internationally Recognized) ISO 13485 Certification Scope of Application: Applicable to all medical device companies exporting products. Certification Content: An international standard for the quality management system of medical devices, covering the entire process of design, production, installation, and service. Function: Demonstrates that the enterprise has the capability to consistently produce products that comply with international standards, serving as the “basic threshold” for entering most markets. Regional Market Access Certification (Select Based on Target Market) EU Market CE Certification: Applicable Products: All medical devices (Class I low-risk products require a Declaration of Conformity, while Classes IIa/IIb/III require a CE certificate). Regulatory Basis: Must comply ...
In response to the growing global challenge of obesity, the World Health Organization recently released its first global guideline on the use of glucagon-like peptide-1 (GLP-1) drugs for the treatment of obesity.Three drugs used to treat obesity in adults: liraglutide, smegglutide, and telpoglutide. The World Health Organization (WHO) defines obesity as an adult body mass index (BMI) of 30 or higher. According to WHO data, obesity is a chronic, relapsing disease, affecting more than one billion people globally. Obesity-related deaths reached 3.7 million in 2024. Without decisive action, the number of obese individuals is projected to double by 2030. WHO Director-General Dr. Tedros Adhanom Ghebreyesus stated, “Obesity is a major global health challenge, and the WHO is committed to supporting countries and people worldwide in addressing it effectively and equitably. The new guidelines acknowledge that obesity is a chronic disease that can be treated with comprehensive, lifelong care. While medication alone ...
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