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Ascentage Pharma’s “Nerlik®” received an oral presentation

Ascentage Pharma (6855.HK) announced today that the company has published the clinical research results of the company’s original Class 1 new drug Olebatinib (trade name: Nerlik®; research and development code: HQP1351) for the treatment of succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) in the form of a mini oral presentation at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting. The clinical data of this oral presentation showed that Olebatinib has sustained clinical efficacy in the treatment of SDH-deficient GIST. As of March 12, 2024, 6 of the 26 patients with SDH-deficient GIST enrolled achieved partial remission (PR), the objective response rate (ORR) was 23.1%, and the median progression-free survival (PFS) was 22 months. In addition, potential mechanism of action (MOA) studies have shown that orebactinib exerts anti-tumor activity by regulating multiple signaling pathways involved in angiogenesis, apoptosis, proliferation and survival. Orebactinib is an original Class 1 new drug ...
- Source: drugdu
- 67
- September 14, 2024
Traditional Chinese Medicine Brands Accelerate Penetration into Young Consumer Groups

In recent years, health-oriented and personalized dietary trends, exemplified by new-style tea beverages, have rapidly gained popularity among young consumers. Building on this foundation, with an increasing awareness of health and wellness, traditional Chinese medicine (TCM) health drinks, with their unique health philosophies and rich cultural backgrounds, have gradually won recognition among younger demographics. Reports from the China Securities Journal indicate that it’s not just beverage products; under consumer demand, renowned TCM brands such as Tong Han Chun Tang, Tong Ren Tang, Lei Yun Shang, and Hu Qing Yu Tang are actively launching new products featuring TCM ingredients, including medicinal dishes, herbal scents, and skincare items, tailored to meet the genuine needs of younger consumers. Experts believe that as these brands expand their product lines and target consumption scenarios, it will help rejuvenate the long-standing TCM brands. Targeting Youth to Enhance Product Offerings Historically, traditional TCM shops have not been ...
- Source: drugdu
- 103
- September 13, 2024
Focusing on the Frontiers of Biomedicine and Creating an Open Source Innovation Ecosystem.

Recently, a reporter from China Securities Journal visited the Shanghai Frontier Biomedical Innovation Center. Driving into the core area of the Zhangjiang Science City, a national-level biomedical base, one can see a modern, curved building from afar. Approaching closer, the open interior, visible through the yellow and white glass, creates a sense of freedom and positivity. “Currently, 10 resident companies and 11 ecological partners have signed cooperation agreements with Shanghai Frontier,” a representative from Shanghai Frontier stated. The center aims to create a “wall-less R&D center,” breaking down traditional barriers and promoting interaction and collaboration among experts, scholars, businesses, and investors from various fields and backgrounds, including industry, education, research, healthcare, and finance. Looking ahead, Shanghai Frontier will focus on cutting-edge biotechnologies such as gene and cell therapy, nucleic acid drugs, and conjugated drugs, hoping to discover and nurture highly innovative and competitive companies and projects while encouraging high-potential innovations ...
- Source: drugdu
- 113
- September 13, 2024
A domestic giant in imaging equipment

Imaging equipment is an indispensable medical product for building a clinical diagnosis and treatment system. Medical imaging equipment interacts with the human body through a certain medium (such as X-rays, electromagnetic fields, ultrasound, etc.), and presents the structure and density of internal tissues and organs of the human body in the form of images for diagnostic physicians to judge and evaluate the health status of the human body. Commonly used medical imaging equipment in clinical practice includes computed tomography (CT), magnetic resonance imaging (MR), X-ray imaging equipment, nuclear medicine diagnostic equipment, and ultrasound equipment (US). Medical imaging of different modalities has different working principles, imaging characteristics, application scenarios, and advantages and disadvantages, but the functions are relatively consistent: Medical imaging equipment is one of the basic diagnostic options before most diseases are currently intervened, especially in the context of aging in China. Most aging-related diseases such as cardiovascular and cerebrovascular ...
- Source: drugdu
- 85
- September 13, 2024
A Chinese innovative pharmaceutical company “died”

On September 5, Connect (Nasdaq: CNTB), a global clinical-stage biopharmaceutical company headquartered in the United States, announced its financial results for the six months ended June 30, 2024 and announced plans to large-scale attrition. In addition, as part of Connect’s transformation into a U.S.-focused company, the company plans to significantly reduce the scale of its operations in China. Just a few months ago, Connect was an innovative pharmaceutical company in China. All these changes are rooted in the clinical setbacks of Connect’s core pipeline product, Rademikibart (CBP-201). This is a fully human monoclonal antibody targeting IL-4Rα, which is a common subunit of IL-4Rα and IL-13 receptors. It directly targets Sanofi’s new autoimmune drug Duprilumab. anti. In the CBP-201 clinical data previously announced by Connect, although some connotations of long-term efficacy data were seen, the improvement in the 16-week data was weaker than that of dupilumab; in addition, because it was ...
- Source: drugdu
- 55
- September 13, 2024
Ultrasonic Knife Alliance’s centralized procurement is imminent, how can China’s brands “overtake on the bend”

On September 3, 2024, the Shenzhen Public Resource Trading Center once again publicly solicited opinions on the “Continuation of Procurement Documents for Centralized Volume Purchase Agreement of Ultrasonic Knife Heads and Pre filled Catheter Flushers (Draft for Comments)”. Enterprises can provide feedback before 17:00 on September 10. The variety of this procurement is ultrasonic blade head (disposable/reusable/integrated handle ultrasonic blade head). After two years, this market is once again experiencing a tense moment. The Guangdong Alliance’s centralized procurement of ultrasonic knives will be launched, and market competition has entered a white hot stage Since the first centralized procurement of ultrasonic cutting heads in Fujian Province in 2020, as of 2024, the centralized procurement areas for ultrasonic cutting heads have spread throughout the country. After this launch, the Guangdong Alliance will become the largest alliance for centralized procurement of ultrasonic knives. At the end of 2021, Guangdong led a 16 province ...
- Source: drugdu
- 84
- September 13, 2024
Two innovative medical devices from Medtronic have been approved for market in China

Recently, the National Medical Products Administration announced the approval of Medtronic’s registration applications for two innovative products, the “Heart Pulse Electric Field Ablation Generator” and the “Disposable Heart Pulse Electric Field Ablation Catheter”. Unique advantages, suitable for two indications It is reported that the two innovative products approved this time are Medtronic’s PFA product – PulseSelect, which is the first PFA product approved by NMPA that can be used for both paroxysmal and persistent atrial fibrillation. PulseSelect is a new technique for treating atrial fibrillation (AF) using pulsed electric fields, which can provide bipolar and biphasic pulsed electric fields through a circular multi electrode array catheter. This technology consists of five parts: a controllable multi electrode annular ablation catheter, a PFA host ECG-Gated、 Tableside control、10Fr bidirectional sheath. It is worth mentioning that PulseSelect’s controllable multi electrode annular ablation catheter features a proprietary biphasic waveform, unique built-in guide wire, and a ...
- Source: drugdu
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- September 13, 2024
Baiaotai and Boheng published TOFIDENCE (a reference to Yamero) in the journal “Arthritis Research and Treatment” ® Phase III clinical data of biosimilars developed with tocilizumab

Baiaotai Biopharmaceutical Co., Ltd. (stock code: 688177) is a global biopharmaceutical enterprise based on science and innovation located in Guangzhou, China, hereinafter referred to as “Baiaotai” or “the Company”. The company announced today that the article “Evaluating the Phase 3 Clinical Study of BAT1806/BIIB800 during the Second Treatment Phase (TP2, Weeks 24-48)” co authored with Bojian has been published in the Arthritis Research&Therapy journal. BAT1806/BIIB800 is a product developed by BioNTech and referenced by Yamero ® The biosimilar drug developed with tocilizumab has been launched in Europe and America under the brand name TOFIDENCE ™. In a phase 3 clinical study, rheumatoid arthritis patients with insufficient response to methotrexate were randomly assigned to three treatment groups in a 1:1:2 ratio: (1) using the original drug for intravenous injection of 8mg/kg every 4 weeks until week 48; (2) Treat with the original drug until week 24, then switch to using BAT1806/BIIB800 ...
- Source: drugdu
- 75
- September 13, 2024
Yingsi Intelligence has discovered an AI driven WRN inhibitor that targets highly microsatellite unstable cancer

WRN has been identified as a synthetic lethal target in highly microsatellite unstable (MSI-H) cancer cells, with therapeutic potential for MSI-H tumor patients who do not respond to existing therapies. The innovative module Alchemisty under Yingsi Intelligent Chemistry42 utilizes non-equilibrium switching method to accurately and quickly estimate the binding free energy of protein ligand complexes, simplifying and accelerating the optimization process of ISM2196. In preclinical studies, ISM2196 has demonstrated strong in vivo anti-tumor efficacy in various MSI-H cancer models, with good selectivity, safety, and ADMET (absorption, distribution, metabolism, excretion, and toxicity) characteristics. Yingsi Intelligent, a clinical stage biopharmaceutical technology company driven by generative artificial intelligence (AI), announced the nomination of preclinical candidate drug ISM2196, a potential “best in class” WRN inhibitor discovered by AI, aimed at treating advanced metastatic microsatellite instability (MSI) cancer through synthetic lethal strategies. The DNA helicase Werner (WRN) is a member of the RecQ helicase family ...
- Source: drugdu
- 61
- September 13, 2024
【EXPERT Q&A】What certification is required for medical device export clearance to the United States?

Drugdu.com expert’s response: Exporting medical devices to the United States for customs clearance involves fulfilling a series of certifications and requirements, primarily encompassing the following aspects: Ⅰ. FDA Registration and Certification FDA Registration: Manufacturers or exporters need to register with the Food and Drug Administration (FDA) in the United States to legally sell medical devices in the American market. This process is typically completed through FDA’s Electronic Registration System (FURLS). 510(k) Premarket Notification: For medical devices classified as “Class II” (Premarket Notification), a 510(k) submission is generally required. This application demonstrates that the device is technologically similar to a legally marketed device and meets FDA requirements. The review period typically takes 90 days. PMA Application: For high-risk medical devices classified as “Class III” (Premarket Approval), a PMA (Premarket Approval Application) may be necessary. This is a more rigorous application requiring substantial clinical data and evidence to prove the safety and ...
- Source: drugdu
- 68
- September 13, 2024

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