/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
2026/07/02[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just been published by the issuer in the Chinese section of this website, a corresponding version of which may or may not be published in this section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 July 2, 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 2026-094

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 Suzhou Shengdi

Asia Biopharmaceutical Co., Ltd. and Shanghai Shengdi Pharmaceutical Co., Ltd. have received approval from the State Food and Drug Administration (hereinafter referred to as (known as the "State Food and Drug Administration") approved and issued the SHR-8068 injection, adebelimab injection, A

The "Drug Clinical Trial Approval Notice" for apatinib sulfonate tablets will launch clinical trials in the near future. Present general

The relevant information is announced as follows:

  1. The basic situation of pharmaceuticals and drugs

Drug Name: SHR-8068 Injection, Adebelimab Injection, Apatinib Mesylate Tablets Dosage Form Injection Tablet

Application Matters Clinical Trial

Acceptance number CXSL2600203 CXSL2600202 CXHL2600174

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

SHR-8068 injection, aderbelimab injection, methanesulfonate accepted on February 10

Apatinib tablets meet the relevant requirements for drug registration and agree to conduct clinical trials. specific Approval conclusion For: SHR-8068 in combination with aderbelimab with or without apatinib for moderate to high A randomized, open, multicenter study of perioperative management of resectable hepatocellular carcinoma at risk of recurrence.

Phase II clinical study.

  1. Other situations of pharmaceuticals

SHR-8068 injection is a fully human anti-CTLA-4 monoclonal antibody introduced by the company, which can enhance anti-CTLA-4

Tumor immune effects. Currently, there are three similar products approved for marketing in the world, including Bristol-Myers Squibb’s

Pilimumab, AstraZeneca’s temsilimumab and Innovent Biologics’ ipilimumab N01 injection. After enquiry,

Combined global sales of ipilimumab and temsilimumab in 2025 were approximately $1.68 billion. As of now, The cumulative R&D investment in projects related to SHR-8068 injection is approximately RMB 455.6 million (unaudited).

Adebelimab injection is a humanized anti-PD-L1 monoclonal antibody independently developed by the company.

Specifically binds to PD-L1 molecules to block the PD-1/PD-L1 pathway that leads to tumor immune tolerance and re-activate

The anti-tumor activity of the immune system is activated to achieve the purpose of treating tumors. The company's adebelimab injection

Two indications have been approved, namely: combined with carboplatin and etoposide for patients with extensive-stage small cell lung cancer. first-line treatment; combined with platinum-containing chemotherapy as neoadjuvant treatment, and continue to use this product as single-agent adjuvant treatment after surgery.

For the treatment of surgically resectable stage II, IIIA, and IIIB disease without known epidermal growth factor receptor (EGFR) mutations

or adult non-small cell lung cancer (NSCLC) patients with anaplastic lymphoma kinase (ALK) rearrangements. There are similar products abroad

Products Atezolizumab (trade name: Tecentriq), Avelumab (trade name: Bavencio) and

Durvalumab (trade name: Imfinzi) is approved for marketing in the United States, among which Atezolizumab and Durvalumab has been approved for marketing in China. Many other similar products have been approved for listing in China. Upon inquiry, 2025

The total global sales of Atezolizumab, Avelumab and Durvalumab are approximately US$11.054 billion.

Up to now, the cumulative R&D investment in projects related to aderbelimab injection has reached approximately RMB 1,225.1 million (without review).

calculation).

Apatinib mesylate tablets are small molecule VEGFR-2 tyrosine kinase inhibitors that can inhibit tumor angiogenesis. Success. This product has been approved for multiple indications in the country, covering gastric cancer, liver cancer, breast cancer and other tumor types. Domestic and foreign

In addition, many similar products such as sorafenib, sunitinib, and pazopanib have been approved for marketing. Upon inquiry

EvaluatePharma database, combined global sales of sorafenib, sunitinib and pazopanib in 2025

totaled approximately $473 million. Up to now, the cumulative R&D investment in projects related to apatinib mesylate tablets has been approximately

646.1 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.

July 2, 2026