PharmaFocus Today – Page 16 – media

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
- 125
- 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
- 117
- 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
- 136
- 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
- 147
- 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
- 100
- 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
- 99
- April 20, 2026
Zai Lab’s “core” innovative drug, the first of its kind, is on the verge of market launch

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 ...
- Source: drugdu
- 107
- April 20, 2026
Eli Lilly’s Tadalafil® and Tadalafil® (mijicillinumab) have been officially launched in China, opening a new chapter in precision targeted therapy for inflammatory bowel disease.

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 ...
- Source: drugdu
- 102
- April 20, 2026
Why Did the “First Listed Company of China’s Biosimilars” Sell Its Only Innovative Drug for 450 Million? The Survival Rules for Biotechs Have Changed.

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, ...
- Source: drugdu
- 130
- April 17, 2026
After 12 years, Humanwell Healthcare Group has launched a groundbreaking oral painkiller designed to prevent abuse

According to the “China Pain Medicine Development Report (2020),” there are over 300 million chronic pain patients in China, and this number is rapidly increasing by 10 to 20 million annually. While pain doesn’t directly threaten life like other diseases, it can lead to a decline in quality of life and may contribute to suicide, premature death, Alzheimer’s disease, depression, and anxiety. Pain is mainly divided into acute pain and chronic pain. Chronic pain refers to pain that persists or recurs for more than three months, and its harmfulness far exceeds that of acute pain. On April 13, 2026 , according to the latest announcement on the official website of the Center for Drug Evaluation ( CDE ) of China, Humanwell Pharmaceutical US, Inc., a subsidiary of Humanwell Healthcare Group, received implied approval for its clinical trial application for hydrocodone bitartrate extended-release tablets, submitted under chemical drug registration category 5.2 ...
- Source: drugdu
- 118
- April 17, 2026

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