4h ago
SUNSHINE PHARMA - VOLUNTARY ANNOUNCEMENT IN RELATION TO THE MARKETING APPROVAL OF INSULIN DEGLUDEC INJECTION BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA)
SUNSHINE PHARMA - VOLUNTARY ANNOUNCEMENT
IN RELATION TO THE MARKETING APPROVAL OF INSULIN DEGLUDEC INJECTION BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA)
with its subsidiaries, the 'Group') on a voluntary basis.
The board (the 'Board') of directors of the Company is pleased to announce that the Insulin Degludec Injection independently developed by the Group has formally obtained marketing approval from the National Medical Products Administration (NMPA), which is available in both cartridge and prefilled pen formats. Relevant details are hereby announced as follows:
I. BASIC INFORMATION OF THE DRUG
Drug Name: Insulin Degludec Injection
Dosage Form: Injection
Specification: 3ml: 300 units
Approval Number: the specification of cartridge-type (Guoyaozhunzi S20260058), the specification of prefilled pen-type (Guoyaozhunzi S20260059)
II. OTHER RELEVANT INFORMATION OF THE DRUG
Insulin Degludec Injection belongs to the fourth-generation long-acting basal insulin analogues, endowed with excellent clinical performance due to its unique molecular structure and mechanism of action. Its core clinical advantages include: (1) a half-life of approximately 25 hours and a duration of action exceeding 42 hours, covering all-day basal insulin requirements with a once-daily administration; (2) a smooth glucose-
lowering profile, with blood glucose variability of only approximately one-fourth that of insulin glargine and minimal fluctuation in plasma concentration after reaching steady state; and (3) a statistically significantly lower incidence of confirmed hypoglycemia
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and nocturnal hypoglycemia compared with insulin glargine. Benefiting from its ultra- long-acting pharmacokinetic characteristics, Insulin Degludec Injection can be administered at any time of the day without requiring a strict fixed injection time,
thereby significantly improving patient medication compliance and flexibility. III. THE GROUP'S FOOTPRINT IN INSULIN
With the marketing approval of Insulin Degludec Injection, the Group's approved
insulin portfolio in the PRC market has increased to six products, establishing a comprehensive insulin product matrix spanning second- to fourth-generation products and covering the three major clinical application scenarios of basal, prandial, and premixed insulin.
In terms of the product pipeline, the Group's Insulin Degludec/Insulin Aspart Injection has reached the marketing authorization review stage, while HEC-151, an innovative once-weekly ultra-long-acting insulin, has entered Phase I clinical trials. Going forward, these products, together with the marketed products, will form a multi-tiered portfolio comprising daily, weekly and combination formulations, thereby driving the continued iteration and advancement of the insulin pipeline.
In terms of international presence, the Group's self-developed Insulin Glargine Injection has received an approval letter from the United States Food and Drug Administration ('FDA') at the end of April 2026, making it the fourth insulin glargine product approved for marketing in the United States, and the Company the first PRC pharmaceutical company to commercialize an insulin glargine product in the United States market. Going forward, the Group will continue to advance overseas registration
filings for multiple insulin products, including insulin aspart and insulin degludec, and will continue to advance the global expansion of its insulin product portfolio, expand its international market share, enhance its international operational capabilities and brand influence, and bring PRC-developed insulin products to the global market to benefit people with diabetes worldwide.
This announcement is made by the Company on a voluntary basis to keep investors informed of the latest business development of the Group, and contains no advertisement or intention regarding the use of any drug, surgical device, therapy or oral product.
By order of the Board Sunshine Lake Pharma Co., Ltd. Dr. ZHANG Yingjun Chairman
Dongguan, the PRC
30 July 2026 As at the date of this announcement, the executive Directors are Dr. ZHANG Yingjun, Mr.
JIANG Juncai and Mr. ZHANG Zhiyong (employee Director), the non-executive Directors are Mr. ZHANG Yushuai, Mr. TANG Xinfa, Mr. ZHU Yingwei and Dr. LI Wenjia, and the independent non-executive Directors are Dr. LI Xintian, Dr. MA Dawei, Dr. LIN Aimei and Dr. YE Tao.
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