Zhixiang Jintai's GR2302 Injection Gets Clinical Trial Approval for Chronic Hepatitis B

Product / Tech
โดย CLS·CN·Read original
Summary · why it matters

Zhixiang Jintai announced that it has received a drug clinical trial approval notice issued by the National Medical Products Administration. The clinical trial application for its investigational product GR2302 injection for subcutaneous use has been approved, with the indication being chronic hepatitis B. GR2302 injection is a bispecific antibody independently developed by the company, based on a TCR-mimic antibody and an anti-CD3 antibody. Currently, no drug targeting the same target has been approved for clinical trials in China. The company cautioned that after completing clinical trials, the drug still needs to submit a new drug application for marketing, and there are risks of uncertainty.

Impact on stocks 1

Theme Impact 1

Related news

2

Gilead Signs PAHO Deal to Expand Lenacapavir Access in 14 Latin American Countries

Gilead Sciences has reached an agreement with the Pan American Health Organization to expand access to its twice-yearly HIV-prevention drug lenacapavir across Latin America and the Caribbean, creating a regional procurement pathway for 14 countries including Brazil, Mexico, Argentina, Colombia and Peru that were outside Gilead's existing voluntary generic-licensing arrangements. Availability will still depend on individual countries' regulatory approvals and decisions to adopt the drug. Gilead expects lenacapavir to generate about $1 billion in 2026 sales, and reported 12% year-over-year HIV sales growth in the second quarter of 2026, with Yeztugo sales reaching $232 million, above the $210 million analyst estimate, after which the company raised its expected 2026 HIV-product sales growth to 9%-10%. Reuters reported that new HIV infections in Latin America and the Caribbean rose 13% between 2010 and 2024, and that lenacapavir demonstrated nearly 100% efficacy in large prevention trials, while Yeztugo carries a U.S. annual list price above $28,000. Gilead has already granted royalty-free voluntary licenses to generic manufacturers for resource-limited countries and is still discussing possible local production with Brazil's Health Ministry, so the expanded access may come with lower pricing and margins than in wealthier markets.
Insider Monkey·18hRead more →

Chiome Bioscience's Influenza Antibody Research Paper Published in International Academic Journal

Chiome Bioscience announced that the results of joint research with a research group from the Infectious Pathology Division of the National Institute of Infectious Diseases at the National Center for Global Health and Medicine has been published in the international academic journal Protein Science. In the study, the researchers designed a unique antigen targeting influenza virus that utilizes molecular mimicry by anti-idiotype antibodies, and showed that it can induce antibodies in inoculated animals that react broadly to multiple types of the virus. Following the announcement, shares of Chiome Bioscience widened their gains in the afternoon session and are currently at 94 yen, up 6 yen from the previous day.
トレーダーズ・ウェブ·2dRead more →

Sunshine Biopharma Advances Lead Coronavirus Drug Candidate into IND-Enabling Studies

Sunshine Biopharma Inc. has advanced its lead Coronavirus drug candidate into IND-enabling studies, the company announced. The nominated compound, a PLpro protease inhibitor, showed nanomolar potency against the viral protease and broad-spectrum activity against SARS-CoV-2 variants of concern in vitro, with high oral bioavailability in mice, rats and dogs and preferential enrichment in the lungs of mice and rats. In K18-hACE2 mice infected with human SARS-CoV-2, repeated oral administrations significantly suppressed pulmonary viral replication in a dose-dependent manner. CEO Dr. Steve Slilaty called the advance a strategically significant development and a validation of the company's discovery infrastructure, adding that the program is being accelerated with regulatory discipline. The company previously published laboratory results on its anti-coronavirus compound library in August 2024 and March 2026 in the Journal of Medicinal Chemistry. Sunshine Biopharma currently has 60 generic prescription drugs on the market in Canada and approximately 12 additional drugs scheduled for launch in the remainder of 2026.
Sunshine Biopharma Inc.·2dRead more →