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    2500   CNE100003PJ8


Delayed Hong Kong Stock Exchange  -  04:08 2022-09-30 am EDT
9.180 HKD   -2.34%
09/06China to Exclude Medical Devices From Bulk-Buying Program
09/01Venus Medtech Announces 2022 Interim Results : quality and efficiency improvement, profitability focus, rapid progress in global presence
09/01Venus Medtech (Hangzhou)'s H1 Loss Widens 76.8%
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China's National Medical Products Administration Approves Venusp-Valve, Venus Medtech's In-House Developed Innovative Transcatheter Pulmonic Valve Replacement System

07/13/2022 | 08:01am EDT

VenusP-Valve, Venus Medtech's in-house developed innovative transcatheter pulmonic valve replacement (TPVR) system, was approved by China's National Medical Products Administration (NMPA) for the treatment of severe pulmonary regurgitation (=3+) in patients after congenital heart defects (CHD) procedure with native right ventricular outflow tract (RVOT). The approval has made VenusP-ValveTM the first TPVR product to be marketed in China, marking another milestone following its CE MDR approval. As the first self-expanding TPVR product approved for marketing in both China and Europe, VenusP-ValveTM sets itself apart with remarkable clinical value.

Uniquely designed with both flared ends, the product ensures the blood flow of branchial artery with bare stents at the outflow end. It provides a stable multi-point anchoring system and enables easy delivery, with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability, VenusP-ValveTM is able to meet the needs of 85% of patients in the case of large RVOT.

For the registration application, the NMPA has accepted the overseas clinical trials data of VenusP-ValveTM as clinical evaluation data, that is, the CE clinical trial data was applied. In April 2022, VenusP-ValveTM received CE marking under the MDR and has been applied to a number of commercial cases. The product was approved by the FDA for compassionate use in two cases in the U.S. in May 2022 and the first compassionate case was completed successfully in June 2022.

In addition, the Investigator Meeting for VenusP-ValveTM US Clinical Study was held, and the Japan-US Harmonization By Doing Program was agreed upon by the FDA and PMDA with a plan to conduct clinical trials in the U.S. and Japan simultaneously, which will accelerate its registration and marketing in both countries. Following its first clinical implantation in 2013, VenusP-ValveTM has been used in nearly 300 cases for humanitarian reasons, spanning more than 20 countries and regions in Asia, Europe, North America, and South America. With clinical data from Europe and China backing up its long-term safety and efficacy, VenusP-ValveTM has received high recognition from the international medical community.

According to three-year follow-up data of the European clinical trial, the success rate for TPVR with VenusP-ValveTM is 100% in 64 patients (some patients have not been included due to the ongoing pandemic). All-cause mortality and surgical re-intervention rates were zero. In addition, no moderate or severe pulmonary regurgitation was observed.

Paravalvular leakage and tricuspid regurgitation were mild or below in 96.87% of subjects. Meanwhile, five-year follow-up data of the Chinese trial reported a 3.64% postoperative five-year all-cause mortality rate. Noteworthily, Venus Medtech earned First Prize of the Technical Invention Award of the Excellent Achievements in Scientific Research (Science and Technology) of Higher Education in March 2021 for its key materials and technologies of self-expanding Interventional pulmonic valve system project, which was mainly applied to VenusP-ValveTM.

Jointly undertaken by the Company and Sichuan University, the project received strategic support from the National Key Research and Development Program under the 13th Five-Year Plan. Academician Prof. Ge Junbo, Director of Cardiology Department at Zhongshan Hospital Affiliated to Fudan University and Principal Investigator (PI) of the Chinese clinical trial of VenusP-ValveTM, congratulated Venus Medtech on the NMPA approval of the product. In recent years, the Center for Medical Device Evaluation (CMDE) of NMPA has continuously optimized its procedures by introducing new policies and boosting review quality and efficiency in accordance with the decision of the State Council to reform the review and approval system of drugs and medical device.

By doing so, the CMDE has effectively expedited the review and approval of domestic innovative medical devices and contributed to the high-quality growth of the industry. New policy documents including the Special Review Approval Procedure for Innovative Medical Devices and Priority Review and Approval Procedure for Medical Devices have been issued to create a green channel for clinically urgent novel devices and accept overseas clinical trial data. The improvements underlined CMDE's science-based, pro-reform orientation.

© S&P Capital IQ 2022
09/06China to Exclude Medical Devices From Bulk-Buying Program
09/01Venus Medtech Announces 2022 Interim : quality and efficiency improvement, profitability f..
09/01Venus Medtech (Hangzhou)'s H1 Loss Widens 76.8%
08/31Venus Medtech Inc. Reports Earnings Results for the Half Year Ended June 30, 2022
08/31Venus Medtech Inc. Announces Change of Employee Representative Supervisor and Chairpers..
07/13China's National Medical Products Administration Approves Venusp-Valve, Venus Medtech's..
07/13Chinese Regulator Approves Venus Medtech's Valve Replacement System
06/22First American Patient Treated with VenusP-Valve™ Under Compassionate Use
06/22Venus Medtech Inc. Announces First American Patient Treated with VenusP-Valve Under Com..
04/13Venus Medtech Completes First-in-Human Study of Bioprosthetic Heart Valve Product
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Sales 2022 515 M 72,4 M 72,4 M
Net income 2022 -387 M -54,4 M -54,4 M
Net cash 2022 2 450 M 344 M 344 M
P/E ratio 2022 -9,28x
Yield 2022 -
Capitalization 3 643 M 512 M 512 M
EV / Sales 2022 2,32x
EV / Sales 2023 2,02x
Nbr of Employees 1 039
Free-Float 73,5%
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Zhen Jun Zi Executive Director & General Manager
Hai Yue Ma Chief Financial Officer & Joint Secretary
Min Zeng Chairman
Min Shao Chairman-Supervisory Board
Hou-Sen Lim Chief Technology & Operating Officer
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