Zhejiang Jingxin Pharmaceutical Co., Ltd. Announces Portfolio Company's Medical Device Granted Entry into Innovative Medical Device Special Review Process

Original Title: ZhejiangJingxin PharmaceuticalAnnouncement of Zhejiang Jingxin Pharmaceutical Co., Ltd. Regarding the Approval of Medical Device Products of Its Participating CompanyInnovative Medical CareAnnouncement on the Special Review Procedure for Medical Devices

The Company and all members of its Board of Directors hereby guarantee that the information disclosed is true, accurate, and complete, with no false records, misleading statements, or material omissions.

According to recent inquiries made by Zhejiang Jingxin Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company”) on the website of the Center for Medical Device Evaluation of the National Medical Products Administration (https://www.cmde.org.cn/), it has been learned that the “External Stent for Vein Grafts” product of its affiliated company, Israel-based Vascular Graft Solutions Ltd. (hereinafter referred to as “VGS”), has been approved by the Center for Medical Device Evaluation of the National Medical Products Administration to enter the special review procedure. The relevant information is hereby announced as follows:

I. Basic Information

Acceptance No.: CQTS2000101

Application Product: External Stent for Venous Graft

Applicant: Vascular Graft Solutions Ltd.

Product Management Category: Class III

Review Conclusion: Approved for review in accordance with the "Special Review Procedures for Innovative Medical Devices"

II. Product Overview

“Venous Graft External Stent” is an external stent for cardiac bypass grafts, woven from biocompatible fibers and cobalt-chromium alloy. It is placed around the graft vessel (transplanted vessel) to provide shaping and resist intrathoracic pressure. This product offers biomechanical support that helps the graft vessel withstand intrathoracic pressure, reduces intimal hyperplasia, and lowers the occlusion rate of the graft vessel. It is easy to use, does not alter existing procedural workflows, and can self-adapt to the graft vessel. Currently, no similar products are available on the domestic market. The launch of this product will fill a gap in this field in China, demonstrating significant clinical value and market potential.

III. Impact on the Company and Risk Disclosure

“Vein Graft External Stent,” developed by Israel’s VGS, has already been launched in the European market. By acquiring an equity stake in VGS, the Company has secured exclusive rights to develop and commercialize this product in China. The product has passed the Special Review Procedure for Innovative Medical Devices, granting it priority handling during registration submission. This will effectively shorten the product registration cycle and accelerate its market launch. Clinical trials for the product will be conducted in China. If approved for marketing, it will further enrich the Company’s product pipeline and have a positive impact on its business operations.

The cycle from clinical trials to market launch for medical devices is long and involves multiple stages, making it susceptible to many unpredictable factors. There is significant uncertainty regarding the progress and outcomes of clinical trials, as well as the future competitive landscape of the product market. The Company will fulfill its information disclosure obligations in a timely manner based on the progress of clinical development. Investors are advised to exercise caution in their decision-making and be mindful of investment risks.

Hereby announced.

Board of Directors of Zhejiang Jingxin Pharmaceutical Co., Ltd.

September 28, 2020