media – Page 2 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

First EGFR ex20ins Lung Cancer Study to Receive ASCO Latest Breakthrough Abstract

Recently, Dizal Medicine announced that it will present multiple latest research achievements in non-small cell lung cancer (NSCLC) at the American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago from May 29 to June 2, 2026. Among them, the results of the international multicenter Phase III clinical study “WU-KONG28” of sunvozertinib (Sunvozhe®) were selected for the Latest Breakthrough Abstract (LBA) oral presentation, becoming the first and currently only study in the EGFR exon 20 insertion mutation (ex20ins) NSCLC treatment field to receive the highest honor of LBA at the ASCO conference. “WU-KONG28” is an international multicenter Phase III, open-label, randomized controlled clinical study conducted in 16 countries and regions worldwide, covering major countries including China, the United States, and Europe. Dizal previously announced that the “WU-KONG28” study met its primary endpoint and achieved positive top-line results. The results showed that compared to platinum-based doublet chemotherapy, sunvozertinib demonstrated statistically ...
- Source: drugdu
- 56
- April 23, 2026
[Warm Congratulations] Fosun Kairen FKC289 Injection Receives NMPA Clinical Approval, Dual-Target CAR-T Innovation Reaches New Heights!

On April 13, 2026, Fosun Kairen’s autologous dual-target (targeting BCMA and CD19) CAR-T product FKC289 injection officially received clinical trial approval from the National Medical Products Administration (NMPA). The product is planned to undergo Phase I/II clinical studies in China for recurrent/refractory membranous nephropathy (R/R MN) and recurrent/refractory primary light chain amyloidosis (R/R ALA), with the application for recurrent/refractory membranous nephropathy being first-in-class. This approval marks the acceleration of FKC289’s development process, potentially benefiting patients soon. ExCell Bio extends warm congratulations to Fosun Kairen on the clinical approval of FKC289 injection! This achievement not only represents a breakthrough in autologous dual-target CAR-T applications in autoimmune diseases but also marks China’s CGT innovation moving toward higher quality development. ExCell’s domestically first OptiVitro® T cell serum-free medium bag (TE000-N072), with its core domestic quality, deeply empowers project development, working alongside excellent industry partners to accelerate the implementation of cutting-edge therapies. Chen Xu, ...
- Source: drugdu
- 60
- April 23, 2026
API China

Organiser：Sinopharm Holdings Reed Exhibition Time： May 13 – May 15, 2026 Address：No. 333 Songze Avenue, Xujing Town, Qingpu District, Shanghai Exhibition hall：National Exhibition and Convention Center (Shanghai) Product range: Pharmaceutical active pharmaceutical ingredients (APIs), pharmaceutical excipients, natural extracts, chemical reagents, intermediates, fine chemical raw materials, Chinese medicinal raw materials, food raw materials and additives, veterinary drug raw materials, feed raw materials and additives, health supplement raw materials and additives, biotechnology, pharmaceutical research and development services, contract custom manufacturing services, registration and pharmaceutical affairs services, training services About API China： China International Pharmaceutical API Expo (API China), as the longest-established exhibition in China’s pharmaceutical sector, was initiated in 1968. The exhibits not only encompass over 24 major categories with more than 50,000 types of APIs but also include all excipients, functional ingredients, internal and external packaging materials, as well as production and testing equipment required for the manufacturing of pharmaceuticals ...
- Source: drugdu
- 49
- April 23, 2026
Just now, Simcere Pharmaceutical received a notification for its “Lendibaimab” product!

Just now, the National Medical Products Administration released information on drug notification documents delivered on April 21, 2026. A total of 9 application numbers received notification documents in this batch , all of which were marketing authorization applications. Among them: Simcere Pharmaceutical received a notification for its application for Ledeqibaimab injection , the reason for which is unknown. The application for its indication is: treatment of atopic dermatitis in adults and adolescents . Ledecibaimab is a highly potent anti -IL-4Rα monoclonal antibody that blocks IL-4Rα signaling induced by IL-4 and IL-13 , and inhibits TF-1 cell proliferation induced by IL-4 and IL-13 . It has the potential clinical significance of faster onset of action, lower dosing frequency, and higher clinical response rate. Ledikuma is developed by Connect Biopharmaceuticals Limited in Hong Kong. In November 2023 , Simcere Pharmaceutical acquired the Greater China rights to Ledikuma with an initial payment of ...
- Source: drugdu
- 59
- April 22, 2026
Sevaartinib tablets approved for marketing.

On April 21, according to the website of the National Medical Products Administration (NMPA), the NMPA has conditionally approved the marketing of the Class 1 innovative drug celvaartinib tablets (trade name: Herxinno) submitted by Bayer HealthCare Pharmaceuticals Inc. through the priority review procedure.This drug is indicated as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have previously received at least one systemic therapy. https://mp.weixin.qq.com/s/g4lHuTRty7BHotg4Y7M6hA
- Source: drugdu
- 59
- April 22, 2026
Good news keeps coming! Six active pharmaceutical ingredients, including Ibrutinib, from Lunan Pharmaceutical have received approval for marketing in China.

Recently, Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received marketing authorization notices from the National Medical Products Administration (NMPA) for six chemical active pharmaceutical ingredients (APIs) : doxorubicin hydrochloride, ibrutinib, pirfenidone, dronedarone hydrochloride, tetraenmenaquinone, and varenicline tartrate . These six APIs cover multiple therapeutic areas, including anti-tumor, anti-fibrotic, anti-arrhythmic, anti-osteoporosis, and smoking cessation. Specific information is as follows: Doxorubicin hydrochloride belongs to the anthracycline antibiotic class and is a cell cycle-specific antitumor drug. Its clinical advantages lie in its broad antitumor spectrum and definite efficacy, and it is often used as a core drug in various combination chemotherapy regimens. Ibrutinib is the first Bruton’s tyrosine kinase (BTK) inhibitor, which is precise in targeting, convenient to take orally, has a long-lasting effect, broad indications, and controllable safety. It is a milestone drug in the history of B-cell malignant tumor treatment. Pirfenidone is used for mild to ...
- Source: drugdu
- 59
- April 22, 2026
Industry News | FDA Approves Merck’s Oral HIV Therapy!

Merck (MSD) today announced that the U.S. FDA has approved Idvynso (doravirine/islatravir, DOR/ISL) dual-drug, single-tablet regimen for the treatment of HIV-1 infection in adults as an alternative to current antiretroviral therapy. The indication is for patients who have achieved virological suppression (HIV-1 RNA below 50 copies/mL) on a stable antiretroviral therapy regimen, have no history of virological treatment failure, and have no known substitutional mutations associated with DOR resistance. This approval is primarily based on week 48 data from two pivotal Phase 3 clinical trials (MK-8591A-051 and MK-8591A-052). In the double-blind MK-8591A-052 trial, the primary endpoint (HIV-1 RNA ≥50 copies/mL) showed that at week 48, 1% (n=342) of participants who switched to Idvynso had a viral load ≥50 copies/mL, compared to 1% (n=171) of participants who continued with the active control drug BIC/FTC/TAF. The secondary endpoint at week 48 showed that 92% of participants who switched to Idvynso maintained virological ...
- Source: drugdu
- 58
- April 22, 2026
Is the belief in Alzheimer’s disease Aβ “collapsed”?

A verdict from a top global evidence-based medicine institution has once again thrust the core theories of Alzheimer’s disease, which have dominated the field for over two decades, into the eye of the storm. In the history of Alzheimer’s disease (AD) drug development, the β-amyloid (Aβ) hypothesis has long been the undisputed “absolute main thread.” Global pharmaceutical companies have invested billions of dollars in clearing Aβ plaques from the brain, launching numerous blockbuster drugs and even influencing FDA approval rules. However, a new report from Cochrane on April 16th presented a revolutionary conclusion: Antibody drugs targeting Aβ offer almost no clinically meaningful benefit to patients and may increase the risk of brain hemorrhage and swelling. Edo Richard, professor of neurology at Radboud University Medical Center and senior author of the paper, even suggested that researchers should abandon the amyloid hypothesis and turn to other targets. Ironically, this report, intended to ...
- Source: drugdu
- 53
- April 22, 2026
Zai Lab’s stock price surged 40% in less than a month; Zoci may become a cornerstone drug.

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 ...
- Source: drugdu
- 49
- April 22, 2026
【EXPERT Q&A】What are the ways to query the technical requirements of medical device products?

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, ...
- Source: drugdu
- 52
- April 22, 2026

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.