HENGRUI PHARMA - Announcement that Jiangsu Hengrui Pharmaceutical Co., Ltd. has received a complete reply letter regarding camrelizumab for injection
HENGRUI PHARMA - An announcement has just been published by the issuer in the Chinese section of this website, a corresponding version of which may or may not be published in this section
or completeness of this announcement, and expressly expressly disclaims any liability arising out of or in reliance upon the whole or any part of the contents of this announcement. assumes no responsibility for any losses caused by such content.
Jiangsu Hengrui Pharmaceuticals Co., Ltd. Jiangsu Hengrui Pharmaceutical Co., Ltd.
(a joint stock limited company incorporated in the People's Republic of China) (Stock code: 1276)
Overseas regulatory announcement
This announcement is made in accordance with Rule 13.10B of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited.
In accordance with the relevant laws and regulations of the People's Republic of China, Jiangsu Hengrui Pharmaceutical Co., Ltd. (the "Company")
The Shanghai Stock Exchange website (www.sse.com.cn) published the following announcement. They are listed below for reference only.
By order of the board of directors Jiangsu Hengrui Pharmaceutical Co., Ltd. Chairman
Mr. Sun Piaoyang
Shanghai, China July 10, 2026
As at the date of this announcement, members of the Board of Directors include (i) Executive Directors Mr. Sun Piaoyang, Mr. Dai Hongbin, and Mr. Feng Jinu; Mr. Zhang Lianshan, Mr. Jiang Ningjun and Mr. Sun Jieping; (ii) Ms. Guo Congzhao, a non-executive director; and (iii)
Independent non-executive directors Mr. Lou Liguang, Mr. Zeng Qingsheng, Mr. Sun Jinyun and Mr. Zhou Ji'en.
Securities code: 600276 Securities abbreviation: Hengrui Medicine Announcement number: Lin 2026-097
Jiangsu Suhenghengrui Medical Pharmaceutical Co., Ltd.
Announcement on the receipt of a complete reply letter regarding cascarerelilizumab for injection
The board of directors and all directors of the company guarantee that the contents of this announcement do not contain any false records or misleading statements.
or major omissions, and assume legal responsibility for the authenticity, accuracy and completeness of its content.
Recently, Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") received a U.S. Food and Drug
FDA (hereinafter referred to as "FDA") regarding camrelizumab for injection combined with apatinib mesylate Biologics License Application for Tablets for the First-Line Treatment of Patients with Unresectable or Metastatic Hepatocellular Carcinoma
(Complete Response Letter, Biologics License Application)
(hereinafter referred to as "CRL"). This approval feedback is mainly related to the CGMP inspection view of apatinib-related production sites.
Regarding inspection items, the site underwent FDA CGMP supervision and inspection in April 2026, and the company has responded to the regulatory agency’s
We will conduct a detailed evaluation of the feedback provided by the organization and start formulating corresponding improvement measures. This application involves The site in question passed EU inspections in 2025. This CRL does not involve product clinical research data,
Safety and effectiveness issues. The company will actively cooperate with the FDA and its partner Elevar
Therapeutics will communicate closely to clarify the subsequent filing plan.
- The basic situation of pharmaceuticals and drugs
Drug name: Camrelizumab for injection Dosage form: injection
Proposed indications (or functional indications): This product combined with apatinib mesylate tablets is used for unresectable or transformed patients.
First-line treatment of patients with metastatic hepatocellular carcinoma.
- Other situations of pharmaceuticals
The final analysis results of the CARES-310 study show that camrelizumab for injection combined with apatine mesylate The median overall survival in the nilpine treatment group reached 23.8 months, in the approved treatment of unresectable or metastatic hepatocellular carcinoma.
Among cancer treatment options, it has become the treatment option with the longest median OS study data to date. Based on solid
Based on the clinical research data, we still maintain full confidence in the long-term potential of this combination program in the field of liver cancer treatment.
heart.
For other relevant information about drugs, please refer to the "Hengrui Pharmaceutical Customs" disclosed by the company on the website of the Shanghai Stock Exchange.
Indicative announcement on the resubmission of the biologics license application for camrelizumab for injection being accepted by the FDA》
(Announcement Number: Pro 2026-018).
- Risk reminders The company will actively communicate closely with the FDA and its partner Elevar Therapeutics to clarify
There is uncertainty about the subsequent filing plan and whether the final listing application will be approved. Drug development, clinical
The cycle from trial approval to production is long and involves many steps, and drug development and launch are prone to uncertainties.
Due to the influence of factors, investors are advised to make prudent decisions and pay attention to preventing investment risks. The company will strictly follow the relevant
It stipulates the obligation to perform information disclosure on the subsequent progress of the project in a timely manner.
Announcement is hereby made.
Board of Directors of Jiangsu Hengrui Pharmaceutical Co., Ltd. July 10, 2026