Johnson & Johnson Vision's CATALYS Precision Laser System Receives NMPA Approval in China

Shanghai, January 27, 2021 /PRNewswire/ -- Johnson & Johnson Vision Care, a business unit of Johnson & Johnson, announced that its femtosecond laser system for ophthalmic surgery, the “Catalys,” has recently received registration approval from the National Medical Products Administration (NMPA). It is the first large-scale medical device in China to gain regulatory approval based on real-world data studies conducted in Boao. With its professional performance characterized by high accuracy, precision, efficiency, and safety, Johnson & Johnson Vision’s “Catalys” will bring significant benefits to more cataract patients in China, enabling them to see more clearly, communicate more effectively, and enjoy a better quality of life.

“From performing the first surgery to successfully obtaining registration approval, Johnson & Johnson Vision’s ‘Catalys’ took only 14 months. This achievement is entirely attributable to the proactive exploration and implementation of China’s ‘New Nine National Policies,’ which aim to accelerate the introduction of global innovative products and technologies,” said Wang Liping, General Manager of Johnson & Johnson Vision in China. “We look forward to continuing our collaboration with Boao Lecheng and various stakeholders to accelerate the adoption of global innovative medical products and solutions in China, thereby benefiting Chinese patients’ eye health and enabling them to enjoy bright and healthy lives!”

Cataracts are currently the leading cause of blindness worldwide. In China, the prevalence of cataracts among individuals aged 60 to 89 is approximately 80%. Surgery remains the only scientifically proven treatment for cataracts. Professor Chen Wei, Deputy Director of the Eye Hospital of Wenzhou Medical University, Director of the Ophthalmology Center at Boao Super Hospital, and principal investigator of the real-world data study on the Catalys femtosecond laser-assisted cataract surgery system, stated: “Based on research practice and data, the device has demonstrated favorable success rates in performing corneal incisions, anterior capsulotomy, and lens fragmentation in adult patients according to its indications, thereby delivering improved postoperative outcomes.”

On November 22, 2019, the first femtosecond laser-assisted cataract surgery in mainland China using the Johnson & Johnson Vision Catalys system was successfully performed at Boao Super Hospital.

Johnson & Johnson Vision’s “Catalys” received special approval for “pilot implementation” in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan on November 15, 2019. One week later, the first surgery using this system was successfully performed at Boao Super Hospital. To date, more than 100 cataract patients have benefited from this innovative technology, regaining clear vision. On January 21, 2021, “Catalys” officially received registration approval from the National Medical Products Administration (NMPA), becoming the first large-scale medical device approved for registration based on real-world data studies conducted in Boao.

“This represents a significant practice and innovation in the regulatory science of the National Medical Products Administration (NMPA), as well as a solid step forward in exploring reforms to China’s drug and medical device review and approval system,” said Gu Gang, Director of the Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration. “The approval of Johnson & Johnson Vision’s ‘Catalys’ marks a new achievement in the NMPA’s support for the development of the Hainan Free Trade Port, and vividly demonstrates how multi-departmental collaboration drives integrated institutional innovation. This outcome will attract more international manufacturers of advanced medical devices and pharmaceuticals, as well as healthcare institutions, to establish operations in Lecheng.”

Johnson & Johnson was among the first multinational healthcare companies to collaborate with the Boao Lecheng International Medical Tourism Pilot Zone, introducing cutting-edge international innovative products into the zone. In December 2019, Johnson & Johnson launched the “Johnson & Johnson–Boao Innovation Chain,” dedicated to building an innovative integrated platform in Boao Lecheng that combines the exhibition of medical research achievements, technology promotion, product application, academic exchange, and training of high-caliber talent. With the successful introduction of the “Catalys” femtosecond laser system for ophthalmic surgery as a strong start, Johnson & Johnson Vision will continue to leverage the “Johnson & Johnson–Boao Innovation Chain” to accelerate the introduction and translation of global innovations, better address the urgent eye health needs of patients in China, and contribute to the Healthy China initiative.

Johnson & Johnson operates multiple registered companies and manufacturing facilities, ranking among the top 100 foreign-funded enterprises in Shanghai for tax contributions. As the fastest-growing region in Johnson & Johnson’s global portfolio, China was designated as a global innovation engine by the company’s Global Executive Committee in Beijing in 2019. Furthermore, Johnson & Johnson is a leading enterprise supporting the Shanghai Municipal Government’s initiative to establish Shanghai as a global science and technology innovation hub. In 2014, the Johnson & Johnson Asia Pacific Innovation Center was established in Shanghai. As one of the company’s four global innovation centers, it leverages Asia’s strategic position, adopting an open innovation model that integrates Johnson & Johnson’s resources, expertise, and regional advantages across Asia-Pacific and worldwide to deliver breakthrough healthcare solutions to patients and consumers globally. Currently, the Asia Pacific Innovation Center is pioneering novel solutions in numerous fields, including artificial intelligence, data science, regenerative medicine, gene therapy, microbiology, and robotics. In June 2019, Johnson & Johnson launched its first innovation incubator in Asia Pacific and the largest globally—JLABS^@ Shanghai has commenced operations in the Zhangjiang High-Tech Park within the Pudong New Area. Since preparations began in 2017, the project has received support and collaboration from multiple parties, including the Shanghai Municipal Government, the Pudong New Area Government, and the Zhangjiang Group. It is one of the key initiatives in Shanghai’s efforts to build a “science and technology innovation center with global influence” and establish a “globally leading new highland for biomedical research and development.”