/HENGRUI PHARMA - Announcement from Jiangsu Hengrui Pharmaceutical Co., Ltd. on Obtaining the Approval Notice for Drug Clinical Trials
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HENGRUI PHARMA - Announcement from Jiangsu Hengrui Pharmaceutical Co., Ltd. on Obtaining the Approval Notice for Drug Clinical Trials

HKEXnews
2026/06/09[Overseas Regulatory Announcement - Other]

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just been published by the issuer in the Chinese section of this website, a corresponding version of which may or may not be published in this section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 June 9, 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 2026-083

Jiangsu Suhenghengrui Medical Pharmaceutical Co., Ltd.

Announcement on Obtaining the Approval Notice for Clinical Trial Approval of Drugs

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") and its subsidiary Shandong Shengdi

Pharmaceutical Co., Ltd. and Guangdong Hengrui Pharmaceutical Co., Ltd. received approval from the State Food and Drug Administration (hereinafter referred to as "National Medical Products Administration"). "Domestic Food and Drug Administration") approved and issued the "Drug Drug Administration" regarding HRS-6209 capsules, HRS-8080 tablets, and HRS-9813 capsules.

"Clinical Trial Approval Notice" and clinical trials will be carried out in the near future. The relevant information is now announced as follows:

  1. Basic information about drugs

Drug name HRS-6209 capsules HRS-8080 tablets HRS-9813 capsules

Dosage Form Capsule Tablet Capsule

Application Matters Clinical Trial Acceptance number CXHL2600223 CXHL2600215, CXHL2600216 CXHL2600217

According to the "Drug Administration Law of the People's Republic of China" and relevant regulations, after review, 2026

HRS-6209 capsules, HRS-8080 tablets, and HRS-9813 capsules accepted on February 25, 2019

Meet the relevant requirements for drug registration and agree to conduct clinical trials. Specifically: HRS-6209 Approval conclusion Combined endocrine therapy and/or HRS-9813 in patients with HR-positive/HER2-negative breast cancer An open, multi-center study on safety, tolerability, pharmacokinetics and preliminary efficacy in

b/Phase II clinical study.

  1. Other conditions of drugs HRS-6209 is a novel selective CDK4 inhibitor that potently inhibits cyclin-dependent

CDK4 inhibits downstream Rb phosphorylation, induces tumor cell arrest in the G1 phase, and then exerts

Anti-tumor effect, clinically intended for the treatment of advanced malignant solid tumors. Improved compared to CDK4/6 inhibitors

Selectivity for CDK6 can improve the hematological toxicity associated with CDK4/6 inhibitors. The project covers multiple breast cancer

The combination clinical trial has entered the Phase II clinical stage. Upon inquiry, no similar products at home and abroad have been approved for listing. city. Up to now, the cumulative R&D investment in HRS-6209 related projects is approximately 158.5 million yuan (unaudited).

HRS-8080 is a new, highly efficient and selective oral estrogen receptor degrader (SERD). Yes

Potently and highly selectively degrade ER, inhibit ER activity and downstream signals, thereby inhibiting tumor cell proliferation.

Several breast cancer clinical trials of this project are being actively carried out and have entered the Phase II/III clinical stage. As of now,

The cumulative R&D investment in HRS-8080 related projects is approximately 312.9 million yuan (unaudited). HRS-9813 is a Category 1 innovative drug independently developed by the company. Preclinical data show that HRS-9813 can show

significantly improves pulmonary fibrosis in mice and has good safety profile; in breast cancer xenograft tumor models, HRS-9813 and HRS-

The combination of 6209 shows the advantages of combination and is generally well tolerated by animals. Upon inquiry, there is currently no similar product at home or abroad.

Drugs have been approved for marketing. Up to now, the cumulative R&D investment in HRS-9813 related projects is approximately 176.8 million yuan.

(Unaudited). 33. Risk reminders

According to the laws and regulations related to drug registration in China, the drug will receive a drug clinical trial approval notice.

After the approval, clinical trials must be carried out and reviewed and approved by the State Food and Drug Administration before it can be produced and marketed. Medicines

The cycle from research and development, clinical trial approval to production is long and has many links. Drug research and development and launch are vulnerable to a variety of factors.

Due to the influence of some uncertain factors, investors are advised to make prudent decisions and pay attention to guarding against investment risks. The company will Actively promote the above-mentioned research and development projects in accordance with relevant national regulations, and perform information disclosure on the subsequent progress of the projects in a timely manner.

Obligation to reveal.

Announcement is hereby made.

Board of Directors of Jiangsu Hengrui Pharmaceutical Co., Ltd.

June 9, 2026