SFST attends South Summit in Spain

Sfst makes waves at south summit in spain

The Secretary for Financial Services and the Treasury, Mr Christopher Hui, continued his visit to Europe. He joined the remarkable technology and start-up event South Summit, met with the top management of the Spanish stock exchange and attended a networking reception with the business community in Madrid, Spain, on June 5 (Madrid time).

Attending the fireside chat at the South Summit, Mr Hui shared with the audience Hong Kong's latest developments in the virtual assets industry. These include the debut of Asia's first six spot virtual asset Exchange Traded Funds (ETFs) in Hong Kong in April. It is noteworthy that Hong Kong pioneered an in-kind subscription and redemption mechanism, allowing more flexibility for investors to subscribe and redeem their ETF units. In fact, as a pioneer in embracing financial innovation, Hong Kong implemented a virtual asset trading platform (VATP) licensing regime in June last year. The city is also working on licensing requirements for other virtual asset operations, including the issuance of stablecoins and over-the-counter trading services.

The South Summit is recognised as one of the world's leading entrepreneurship and innovation platforms for start-ups, investors and institutions to connect. The event in Madrid this year brings together some 500 speakers, 120 investment funds and over 20 unicorns from around the world.

In Madrid, Mr Hui on the same day met with the Chief Executive Officer of BME (Bolsas y Mercados Españoles, Spanish Stock Exchange and Market), Mr Javier Hernani Burzako. Mr Hui shared Hong Kong's measures to enhance stock market liquidity and streamline the listing regime targeting specialised technology sectors, and he expressed hope to explore chances of collaboration between both sides.

Mr Hui also paid a courtesy call to the Chinese Ambassador to Spain, Mr Yao Jing. He told Mr Yao that benefitting from the advantages of "one country, two systems", coupled with the staunch support of the country, the Hong Kong Special Administrative Region Government will continue to strengthen exchanges and co-operation with Spain.

In the evening, Mr Hui joined a networking cocktail event with the business community co-organised by the Hong Kong Economic and Trade Office in Brussels, Invest Hong Kong and the Spain Hong Kong Business Association. He told the participating guests that Hong Kong has all the necessary networks and resources to help Spanish businesses gain easier access to the Guangdong-Hong Kong-Macao Greater Bay Area and the vast Mainland China market. He also said Spain and Hong Kong have much to share and benefit each other, such as acknowledging the power of innovation technology and cherishing the vibrant creative industries.

Mr Hui departed for Lisbon, Portugal, to continue his visit in Europe upon completing his itinerary in Spain.

SFST attends South Summit in Spain Source: HKSAR Government Press Releases

SFST attends South Summit in Spain Source: HKSAR Government Press Releases

SFST attends South Summit in Spain Source: HKSAR Government Press Releases

SFST attends South Summit in Spain Source: HKSAR Government Press Releases

SFST attends South Summit in Spain Source: HKSAR Government Press Releases

SFST attends South Summit in Spain Source: HKSAR Government Press Releases

SFST attends South Summit in Spain Source: HKSAR Government Press Releases

Another two new drugs approved under "1+" mechanism

A Government spokesman announced today (December 16) that two more new drugs submitted under the "1+" mechanism have been approved for registration in Hong Kong. These new drugs in two different dosages are used to treat patients with extensive-stage small cell lung cancer, creating more treatment options for patients in Hong Kong and facilitating more good drugs for use in Hong Kong.

The Hong Kong Special Administrative Region (HKSAR) has implemented the "1+" mechanism since November 1, 2023, for facilitating the registration of new drugs used for the treatment of life-threatening or severely debilitating diseases in Hong Kong. With effect from November 1, 2024, the "1+" mechanism has been extended to all new drugs, including all new chemical or biological entities and new indications, and vaccines and advanced therapy products. New drugs that are supported by local clinical data and recognised by local experts can be applied for registration in Hong Kong by submitting approval from one reference drug regulatory authority (instead of two in the past).

The above products for extensive-stage small cell lung cancer have been approved by the drug regulatory authority in the United States and submitted for registration application in Hong Kong under the "1+" mechanism. Having evaluated the clinical data and relevant information submitted by the applicant and advice given by local expert, the Registration Committee under the Pharmacy and Poisons Board of Hong Kong considered that the new drugs satisfied the criteria of safety, efficacy and quality, and approved the registration of the new drugs. The Department of Health (DH) has already notified the applicant of the result of the applications.

The "1+" mechanism serves to attract more new drugs from different parts of the world seeking approval for registration in Hong Kong, giving patients more choices and further strengthening the local capacity for drug evaluation while enhancing the development of relevant software, hardware and expertise with a view to progressing towards "primary evaluation".

Since the implementation of the "1+" mechanism, a total of nine new drugs have been approved under this mechanism. The DH has been promoting the "1+" mechanism through different channels and so far has received more than 350 enquiries from over 90 pharmaceutical companies, including those from overseas and the Mainland. Many companies have expressed interests in submitting applications for registration of their products, including advanced therapy products, under the extended "1+" mechanism.

Meanwhile, the DH will continue its efforts to bring along the reform of the approval mechanism of drugs and medical devices as announced in "The Chief Executive's 2024 Policy Address". These include putting forward a timetable for establishing the Hong Kong Centre for Medical Products Regulation and charting a roadmap towards "primary evaluation" in the first half of 2025, as well as formulating strategies and measures to facilitate research and development of drugs and medical devices.