Announcement of Jiangsu Hengrui Pharmaceutical Co., Ltd. on Obtaining Drug Registration Approval

Securities code: 600276 Securities abbreviation: Hengrui Medicine Announcement number: Lin 2026-086

Jiangsu Hengrui Pharmaceutical Co., Ltd.

Announcement on Obtaining Drug Registration Approval

The company's board of directors and all directors guarantee that the contents of this announcement do not contain any false records, misleading statements or major omissions, and assume legal responsibility for the authenticity, accuracy and completeness of its contents.

Recently, Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") received a notice from the National Medical Products Administration (hereinafter referred to as the "National Medical Products Administration"), approving the company's independently developed CDK4/6 inhibitor dalpiciclib isethionate tablets for new indications. The relevant information is now announced as follows:

1. Basic information about drugs

Drug name: Dalpiciclib isethionate tablets

Dosage form: tablet

Specifications: 50mg, 125mg

Registration classification: Chemicals Class 2.4

Acceptance number: CXHS2500044, CXHS2500045

Prescription/Over-the-Counter Drugs: Prescription Drugs

Approved indications: This product is used in combination with endocrine therapy for the adjuvant treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer patients with a high risk of recurrence.

2. Approved indications of drugs

Dalpiciclib was first approved for marketing in China in 2021. It has been approved for two indications: This product is suitable for patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer: 1. Used in combination with aromatase inhibitors as initial endocrine therapy; 2. Used in combination with fulvestrant for patients with disease progression after previous endocrine therapy.

3. Other information about drugs

Breast cancer ranks among the top morbidity and mortality rates of malignant tumors in women worldwide1, posing a serious threat to women's health. The statistical analysis report on malignant tumor incidence and death data in China in 2024 shows that the number of new cases of breast cancer in Chinese women per year is 376,0002. HR+/HER2- breast cancer is the most common clinical molecular subtype, accounting for approximately 70% of all cases3. Studies have confirmed that even after receiving standard postoperative adjuvant endocrine therapy, some patients with HR+/HER2- early breast cancer still face a continued risk of recurrence for up to 20 years4. Previously, CDK4/6 inhibitors available in China mainly relied on evidence-based evidence from Western populations in the adjuvant treatment of HR+/HER2- early-stage breast cancer. However, the genetic background, biological characteristics, and clinical diagnosis and treatment of breast cancer patients in China are somewhat different from those in foreign countries. For example, the age of onset is relatively young, with the median age at diagnosis being only about 45-49 years old5, and the risk of recurrence is higher; 62.9% of women are diagnosed before menopause6, making it relatively more difficult to treat. There is an urgent need to explore treatment options that are closer to the current status of diagnosis and treatment of HR+/HER2- early breast cancer patients in China.

Dalpiciclib isethionate tablets are oral, highly efficient and selective small molecule CDK4/6 inhibitors independently developed by the company. The approval of this new indication is based on the positive results of a multi-center, randomized, double-blind, placebo-controlled large-scale phase III clinical trial (study code: DAWNA-A)7,8. The DAWNA-A study is the first phase III clinical study of adjuvant therapy for high-risk patients with early breast cancer based on 100% of the Chinese population and achieving positive results. A total of 5,274 Chinese stage II-III HR+/HER2- early-stage high-risk breast cancer patients were enrolled. About 60% of them were premenopausal/perimenopausal patients, which is deeply consistent with the incidence characteristics of the Chinese breast cancer population. Among the study results, the first interim analysis showed that at a median follow-up of 20.3 months, the dalpiciclib combined with endocrine therapy group significantly improved invasive disease-free survival (IDFS) compared with the placebo group, and the absolute benefit rate of 2-year IDFS was 4.5% (94.7%). vs.90.2%), the risk of disease progression or death was reduced by 44.5% (HR=0.56, 95%CI: 0.43-0.71, P<0.0001)7. The results of the updated second interim analysis showed that at a median follow-up of 27.0 months, the IDFS benefit of the dalpiciclib combined with endocrine therapy group was sustained, with an absolute benefit rate of 3.2% in 3-year IDFS (90.6% vs. 87.4%), and a significant reduction of 40.0% in the risk of disease recurrence or death (HR=0.60, 95%CI: 0.49-0.74)10. IDFS benefit was consistent across subgroups2. Disease-free survival (DFS) and distant disease-free survival (DDFS) were also significantly improved8.

The approval of dalpiciclib for this indication marks the expansion of its clinical layout of breast cancer from late-stage to early-stage adjuvant treatment, and also fills the gap in the field of early-stage adjuvant treatment of HR+/HER2- breast cancer with China's independently developed CDK4/6 inhibitors. At present, dalpiciclib combined with endocrine adjuvant therapy for HR+/HER2- early-stage high-risk breast cancer has been officially included in the 2026 version of the "Chinese Society of Clinical Oncology (CSCO) Breast Cancer Diagnosis and Treatment Guidelines" and the 2026 version of the "Chinese Anti-Cancer Association Breast Cancer Diagnosis and Treatment Guidelines and Standards".

Currently, Pfizer's Palbociclib (trade name Ibrance), Novartis' Ribociclib (trade name Kisqali), and Eli Lilly's Abemaciclib (trade name Verzenio) have been approved for marketing at home and abroad. Among them, the only CDK4/6 inhibitors approved for early adjuvant treatment of breast cancer in China are Ribociclib and Abemaciclib. After querying the EvaluatePharma database, the total global sales of the above similar products in 2025 will be approximately US$14.637 billion. Up to now, the cumulative R&D investment in projects related to dalpiciclib isethionate tablets is approximately 1,287.02 million yuan (unaudited).

4. Risk warning

The company attaches great importance to drug research and development and strictly controls the quality and safety of drug research and development, manufacturing and sales. After a drug is approved, its production and sales are easily affected by some uncertain factors. Investors are kindly requested to make prudent decisions and pay attention to guarding against investment risks.

Announcement is hereby made.

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

June 16, 2026

1.Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263.

2. Sun Kexin, Li Li, Wang Shaoming, et al. Analysis of the prevalence of malignant tumors by region in China in 2024 [J]. Chinese Journal of Oncology, 2026, 48 (3): 400-412.DOI: 10.3760/cma.j.cn112152-20260205-00079.

3.GIAQUINTO AN, et al. Breast cancer statistics 2024. CA A Cancer J Clinicians, 2024, 74(6): 477-495.

4. National Cancer Center for Quality Control Breast Cancer Expert Committee, Chinese Anti-Cancer Association Cancer Drug Clinical Research Professional Committee, Chinese Anti-Cancer Association Breast Cancer Professional Committee. HR+/HER-2-Early Breast Cancer Recurrence Risk and Clinical Management Expert Consensus (2025 Edition). Chinese Journal of Oncology, 2025, 47(7): 599-616.

5. Wang X, et al. Landscape of young breast cancer under 35 years in China over the past decades: a multicentre retrospective cohort study (YBCC-Catts study). EClinicalMedicine. 2023 Sep 22;64:102243

6．Fan L, Strasser-Weippl K, Li JJ, St Louis J, Finkelstein DM, Yu KD, Chen WQ, Shao ZM, Goss PE. Breast cancer in China. Lancet Oncol. 2014 Jun;15(7):e279-89.

7. Zhi-Ming Shao, et al. Dalpiciclib plus endocrine therapy as adjuvant treatment for HR+/HER2– early breast cancer: the randomized, phase 3, DAWNA-A trial. 2025 ASCO 515.

8. Zhi-Ming Shao, et al. Dalpiciclib plus endocrine therapy as adjuvant treatment for HR+/HER2- early breast cancer: updated results from the phase 3, DAWNA-A trial. 2025 SABCS Abstract PS2-13-09.