PharmaFocus Today – Page 7 – media

[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
- 82
- 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
- 72
- 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
- 73
- 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
- 75
- 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
- 72
- 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
- 66
- 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
- 64
- April 22, 2026
Hengrui’s new Class 1 drug for heart failure has been approved for clinical trials.

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 ...
- Source: drugdu
- 78
- April 20, 2026
China’s innovative drugs’ breakthrough in the fight against cancer

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 ...
- Source: drugdu
- 73
- April 20, 2026
GenSci, an oral growth hormone, has been approved for clinical trials!

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 ...
- Source: drugdu
- 71
- April 20, 2026

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