Zai Lab has recently caused a stir in the capital market, with its stock price surging 40% in less than a month. Behind this impressive performance is the strong potential of its core pipeline, zoci (ZL-1310), which is gradually growing into a cornerstone drug in the field of oncology treatment , injecting strong momentum into the company’s future development. Zoci’s impressive data is the core support for its potential status as a cornerstone drug . This drug is a potentially first-in-class DLL3 ADC . In patients with brain metastases from extensive-stage small cell lung cancer (ES-SCLC), the confirmed intracranial objective response rate (iORR) at a dose of 1.6 mg/kg was 62.5% , including 4 cases of complete remission. Fourteen patients remained disease-free at a median follow-up of 9.2 months. In terms of safety, zoci also performed excellently, with only 16.4% of grade 3 or higher treatment-related adverse events in the ...
Drugdu.com expert’s response: Here are the ways to query the technical requirements of medical device products: National Medical Products Administration (NMPA) Official Website Path: Enter the NMPA official website and search through the “Medical Device Standard Catalog Query” or “Compulsory Industry Standards for Medical Devices” sections to retrieve the currently effective catalog of medical device standards. Explanation: As the official regulatory authority for the medical device industry, the NMPA issues regulations and standards with authoritative status. However, some specific document contents may need to be downloaded from other platforms. National Institutes for Food and Drug Control (NIFDC, also known as the Chinese Institute for Food and Drug Control) Official Website Path: Log in to the NIFDC official website, navigate to the “Data Query” section, and select “Medical Device Standard Query.” Explanation: As the standard management center for medical devices under the NMPA, the NIFDC provides a wealth of standard resources, ...
Organiser:Guangdong Hospital Association, Shenzhen Cleanroom Industry Association Time:May 29 – May 31, 2026 Address:No. 1000 Xingang East Road, Haizhu District, Guangzhou City, Guangdong Province Exhibition hall:Guangzhou Poly World Trade Center Expo Product range: Medical Imaging: CT, DR, medical X-ray systems, ultrasonic diagnostic instruments, magnetic resonance equipment, tumor treatment machines, medical film and processing systems, medical 3D printing equipment, etc. Remote Mobile Intelligent Monitoring Healthcare: Sleep monitoring devices, remote ECG, blood pressure, blood oxygen, and body temperature monitoring devices, cloud blood pressure monitors, Bluetooth blood pressure and glucose monitors, wearable medical devices, and health kiosks, etc. Mobile Healthcare: Telemedicine, apps, big data cloud platforms, physical examinations, rehabilitation, home healthcare, wearable medical electronics, sports health, massage/physiotherapy, medical beauty electronics, intelligent elderly care service platforms/solutions, etc. Diagnostic and Therapeutic Equipment: Endoscopic systems, otorhinolaryngological instruments, dynamic analysis instruments, cryogenic freezing equipment, dialysis treatment equipment, emergency medical equipment; surgical instruments, electrosurgical units and consumables, ...
Recently, Jiangsu Hengrui Medicine announced that its subsidiary, Shandong Shengdi Medicine, received the “Drug Clinical Trial Approval Notice” for HRS-7156 tablets issued by the National Medical Products Administration , and will soon conduct clinical trials for the indication of heart failure . HRS-7156 tablets are a Class 1 new drug independently developed by the company. Preclinical data show that HRS-7156 can significantly improve cardiac function and lesions. Currently, there are no similar drugs approved for marketing in China or abroad. To date, the cumulative R&D investment in the HRS-7156 related projects is approximately RMB 37.6 million (unaudited). It is worth noting that not long ago, Hengrui Medicine announced that its HRS-5765 tablets had been approved to conduct clinical trials, with the indication being heart failure. This drug is classified as a Class 1 new drug. Preclinical data shows that HRS-5765 can significantly improve cardiac function and lesions. Currently, no similar ...
Scientific cancer prevention begins with medication. As we approach the 32nd National Cancer Prevention and Control Week, we not only need to popularize the health concept of “early prevention, early screening, and early treatment,” but also pay attention to how innovative drugs can buy more time for life. In recent years, China has made remarkable breakthroughs in the research and development of new anti-cancer drugs— from bispecific antibodies to ADC drugs, from targeted therapy to immune combination regimens, a series of “Chinese solutions” are profoundly changing the diagnosis and treatment landscape of high-incidence cancers. 01 The serious challenges of high-incidence cancers Cancer has become the leading chronic disease threatening the health of Chinese residents. According to the latest epidemiological data released by the National Cancer Center, lung cancer, colorectal cancer, thyroid cancer, liver cancer, and stomach cancer rank among the top five in incidence rates in China , while the ...
On April 16, the CDE website showed that GenSci Pharmaceutical’s oral small molecule growth hormone secretion-promoting drug GS3-007a dry suspension has been approved for a new indication: the treatment of idiopathic short stature (ISS) in children. GS3-007a dry suspension is registered as a Class 1 chemical drug. It is an oral small molecule growth hormone secretin receptor type 1a (GHSR-1a) agonist. By acting on GHSR-1a of the pituitary gland, it enhances the release of endogenous growth hormone. It has been approved to conduct clinical trials for ISS, for the diagnosis of growth retardation in children caused by endogenous growth hormone deficiency and adult growth hormone deficiency.As one of the first oral growth hormone secretion-stimulating drugs to enter the clinical stage in China and the first in the world to be used for the treatment of ISS, the advancement of this drug has brought a new direction to the treatment of ...
Small cell lung cancer (SCLC) is known as the “small lung killer” due to its high invasiveness and malignancy. Statistics show that about 80% of small cell lung cancer patients are diagnosed at an extensive stage (ES-SCLC), with an extremely poor prognosis. The median overall survival time is only 7 to 10 months, and the 2-year overall survival rate is only 10% to 20%. On April 18 , 2026 , Zai Lab officially announced that it will present the latest clinical data of its antibody-drug conjugate (ADC) zocilurtatug pelitecan (Zoci, formerly known as ZL-1310) targeting DLL3 at the 2026 American Association for Cancer Research (AACR) Annual Meeting. The study showed that the drug achieved rapid and significant intracranial remission in previously treated patients with brain metastases from extensive-stage small cell lung cancer (ES-SCLC), and also demonstrated encouraging antitumor activity in patients with extrapulmonary neuroendocrine carcinoma (epNEC). picture According to publicly ...
April 18, 2026 – Eli Lilly China today announced the launch in China of its innovative drugs, Antrolet® (mijizumab injection) and Antrolet® ( mijizumab injection (subcutaneous injection)), for the treatment of inflammatory bowel disease (IBD). Antrolet® and Antrolet® (mijizumab), as inhibitors targeting the IL-23 p19 subunit, were approved by the National Medical Products Administration of China in February 2026 for the treatment of moderate to severe active ulcerative colitis (UC) and moderate to severe active Crohn’s disease (CD) in adults. These drugs have the potential to help IBD patients achieve early symptom improvement, mucosal healing, and stable control for up to 3-4 years , providing an innovative option for precision targeted therapy of IBD in China. Professor Chen Minhu, Chairman of the 11th Chinese Society of Gastroenterology, Head of the 12th Chinese Society of Inflammatory Bowel Disease Group, and Academic Leader and Chief Expert of Gastroenterology at the First Affiliated ...
Drugdu.com expert’s response: Core Requirements for Product Instructions under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746) to Ensure Safety, Effectiveness, and Proper User Application I. Basic Information Requirements Manufacturer and Authorized Representative Information Must include the manufacturer’s full name, address, and the name and address of the EU authorized representative (if the manufacturer is located outside the EU). Example: If the manufacturer is based in China, the EU authorized representative’s contact details must be clearly indicated. Product Identification and Classification Must specify the product name, model number, unique device identifier (e.g., UDI code), and IVD product classification (Class A/B/C/D). Example: The front page of the instructions should clearly state: “Product Name: XX Blood Glucose Meter, Classification: Class B.” CE Marking and Compliance Statement Must include the CE mark and indicate compliance with IVDR requirements. Example: Display “CE 2017/746” prominently on the cover or a visible location, along ...
Late night on April 14, Bio-Thera Solutions issued an announcement stating that it would transfer Bevebatide Citrate Injection (Betanin), its Class 1 innovative drug that had been on the market for only 15 months, to Lepu Pharmaceutical, a subsidiary of Lepu Medical, for a total price of 450 million yuan. This “major new drug development” project, which once embodied the company’s ambition to expand into innovative drugs, has been wholly divested together with its marketing authorization, intellectual property rights, and commercialization interests. On April 14, prior to the announcement, Bio-Thera’s share price surged 5.96% in a single day, showing a clear signal of capital inflow. On the day following the announcement, the stock plunged 6.14%, with trading volume nearly doubling to a phased peak. Behind the sharp divergence between long and short positions lies the market’s re-evaluation of the nature of the deal: this is not a simple asset disposal, ...
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