Zelgen Pharmaceutical: Zelgen Pharmaceutical's announcement on voluntary disclosure of recombinant human thrombin inclusion in the 2024 National Reimbursement Drug List
DATE:  Nov 29 2024

Stock code: 688266 Stock abbreviation: Zelgen Pharmaceutical Announcement No.: 2024-047

Suzhou Zelgen Biopharmaceutical Co., Ltd

Regarding the voluntary disclosure of recombinant human thrombin inclusion in 2024

Announcement of the National Medical Insurance Drug List

The board of directors and all directors of the company guarantee that there are no false records, misleading statements or material omissions in the content of this announcement, and assume legal responsibility for the authenticity, accuracy and completeness of its content in accordance with the law.

Important Content Notes:

On November 28, 2024, the National Healthcare Security Administration and the Ministry of Human Resources and Social Security announced the National Health Security Administration

The recombinant human thrombin independently developed by Suzhou Zelgen Biopharmaceutical Co., Ltd. (hereinafter referred to as the "Company") has been included in the National Medical Insurance Drug List through the national medical insurance negotiation. 2024 Nation

The NRDL will be implemented from January 1, 2025.

The inclusion of recombinant human thrombin in the National Medical Insurance Drug List will be conducive to the sales of the product, have a positive impact on the company's long-term business development, and is not expected to have a significant impact on operating results in the short term. Investors are advised to make prudent decisions and pay attention to preventing investment risks.

The relevant information is hereby announced as follows:

First, the basic situation of drugs

Name of drug: Recombinant human thrombin

Dosage form Coating

Specification: 5000IU/piece

This product is used in adults by standard surgical hemostasis techniques (such as suture, ligation or electrocoagulation)

Indications Ineffective or infeasible to control bleeding, promote surgical wound bleeding or capillary and small

Hemostasis of venous bleeding.

Medical insurance classification Category B

Medical insurance payment standard 373.00 yuan (5000IU/piece)

The agreement is valid from January 1, 2025 to December 31, 2026

Second, the relevant situation of drugs

Recombinant human thrombin is a highly specific human serine protease developed based on the company's R&D and industrialization platform for new complex recombinant protein drugs and new antibody drugs. Recothrom is the only product of its kind in the world, and has been marketed and sold abroad for many years.

When recombinant human thrombin is applied externally to the bleeding site, it can effectively activate platelets and catalyze the conversion of fibrinogen to fibrin, which is a necessary step in the formation of blood clots, so as to achieve effective hemostasis. Recombinant human thrombin has the characteristics of high purity and high hemostatic activity, as well as no risk of viral contamination and low risk of immunogenicity, which can avoid the safety hazards of traditional biochemical products under the condition of effective hemostasis. Recombinant human thrombin is expected to become an important product in local hemostasis drugs for surgery due to its rapid hemostasis and safety advantages.

3. Impact on the company and risk warning

The inclusion of recombinant human thrombin in the 2024 National Reimbursement Drug List reflects the recognition of the drug by the National Healthcare Security Administration in terms of clinical value, patient benefits, and degree of innovation. In the future, the company will work closely with all parties to promote the implementation of medical insurance policies, and strive to benefit more patients.

The inclusion of recombinant human thrombin in the 2024 National Medical Insurance Drug List will be conducive to the sales of the product, help the company further improve the affordability and accessibility of the drug among patients, and further promote the marketing of the drug, increase the sales scale, and have a positive impact on the company's long-term business development, and is not expected to have a significant impact on operating performance in the short term. The specific medical insurance reimbursement rules and other relevant information shall be subject to the information published by the National Healthcare Security Administration and other relevant government departments. Investors are advised to make prudent decisions and pay attention to preventing investment risks.

The announcement is hereby made.

Board of Directors of Suzhou Zelgen Biopharmaceutical Co., Ltd

November 29, 2024

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