Hong Kong approves three new drugs, enhancing treatment options under the 1+ mechanism for patients with serious conditions

Three other new drugs approved for registration under "1+" mechanism

A Government spokesman announced today (February 27) that three more new drugs have been approved for registration under the "1+" drug approval mechanism, bringing the total number of new drugs approved for registration under this mechanism to 19. These three new drugs are used respectively to treat patients with type 2 diabetes mellitus, chronic obstructive pulmonary disease and unresectable or metastatic non-small cell lung cancer, bringing more treatment options to patients. The Government continues to strive to accelerate the introduction of innovative drugs and medical devices so that patients can gain early access to advanced diagnoses and treatments while developing Hong Kong into an international health and medical innovation hub.

Photo source: reference image

Three new drugs approved

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The "1+" mechanism has been implemented since November 1, 2023, to facilitate 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 evidence of approval from one reference drug regulatory authority (instead of two in the past).

The above new drug used to treat type 2 diabetes mellitus has been approved by the National Medical Products Administration, while the other two have been approved by the regulatory authority of the United States and submitted for registration applications under the "1+" mechanism. Having evaluated the clinical data and relevant information submitted by the applicants and advice given by local experts, 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 applicants of the results of their applications.

Paving the way towards primary evaluation

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Since the implementation of the "1+" mechanism, a total of 19 new drugs, including the above three drugs, have been approved under this mechanism. Seven of them have been listed in the Hospital Authority Drug Formulary. The DH has been promoting the "1+" mechanism through different channels and has so far received more than 770 enquiries from around 200 pharmaceutical companies, including those from overseas and the Mainland. Many companies have expressed interest in submitting applications for registration of their products, including advanced therapy products, under the extended "1+" mechanism. Since the launch of the pre-new drug application consultation service in March last year, the DH has already held a number of briefing seminars and workshops. The DH has also rolled out pre-new drug application meetings since December last year to enhance efficiency in processing relevant applications.

"The Chief Executive's 2025 Policy Address" announced that the Government will accelerate the reform of the regulatory system of drugs and medical devices, thereby consolidating Hong Kong's position as an international health and medical innovation hub. The DH will expedite the "1+" mechanism for new drugs, piloting priority evaluation and approval of innovative drugs as recommended by the Hospital Authority for treatment of severe or rare diseases and to accelerate patients' use of the advanced treatments. The DH will establish the Hong Kong Centre for Medical Products Regulation by the end of 2026, and implement "primary evaluation" for new drug registration in phases beginning in 2026. The DH will continue to proactively advance preparatory work for "primary evaluation" for new drug registration and progressively establish a robust approval system, providing strong momentum for the development and market expansion of the healthcare industry in the HKSAR, the Mainland, and beyond, thereby transforming Hong Kong into an international health and medical innovation hub.

The Department of Health (DH), Photo source: HKSAR Government Press Releases

Hong Kong Customs detects two dangerous drugs cases and seizes suspected drugs worth about $7.95 million

Hong Kong Customs detected two dangerous drugs cases in Tseung Kwan O and Hong Kong International Airport respectively yesterday (May 21) and today (May 22), and seized a total of about 21.8 kilograms of assorted drugs with a total estimated market value of about $7.95 million. Two men and one woman, aged between 38 and 49, were arrested.

In the first case, Customs officers intercepted a 48-year-old man and a 49-year-old woman in Tseung Kwan O during an anti-narcotics operation yesterday afternoon. About 3.8kg of suspected drugs, including ketamine, methamphetamine, etomidate capsules, psilocybin mushrooms, MDMA and a batch of suspected drug packaging paraphernalia were found in their residence in the same district. They were then arrested.

In the second case, a 38-year-old male passenger arrived in Hong Kong from Amsterdam, the Netherlands, today. During customs clearance, Customs officers found about 18kg of suspected ketamine inside his check-in suitcase and 33 sticks of duty-not-paid cigarette inside his carry-on baggage. The man was subsequently arrested.

The arrested man and woman in the first case have been jointly charged with one count of trafficking in a dangerous drug and one count of possession of apparatus fit and intended for the inhalation of a dangerous drug. The case will be brought up at the Kwun Tong Magistrates' Courts tomorrow (May 23), while an investigation is ongoing for the second case.

Customs will continue to step up enforcement against drug trafficking activities through intelligence analysis. The department also reminds members of the public to stay alert and not participate in drug trafficking activities for monetary return. They must not accept hiring or delegation from another party to carry controlled items into and out of Hong Kong. They are also reminded not to carry unknown items for other people.

Customs will continue to apply a risk assessment approach and focus on selecting passengers from high-risk regions for clearance to combat transnational drug trafficking activities.

Under the Dangerous Drugs Ordinance, trafficking in a dangerous drug is a serious offence. The maximum penalty upon conviction is a fine of $5 million and life imprisonment.

Under the Dutiable Commodities Ordinance, cigarettes are dutiable goods to which the DCO applies. Any person who imports, deals with, possesses, sells or buys illicit cigarettes commits an offence. The maximum penalty upon conviction is a fine of $2 million and imprisonment for seven years.

Members of the public may report any suspected drug trafficking activities to Customs' 24-hour hotline 182 8080 or its dedicated crime-reporting email account (crimereport@customs.gov.hk) or online form (eform.cefs.gov.hk/form/ced002).

Hong Kong Customs detects two dangerous drugs cases and seizes suspected drugs worth about $7.95 million Source: HKSAR Government Press Releases

Hong Kong Customs detects two dangerous drugs cases and seizes suspected drugs worth about $7.95 million Source: HKSAR Government Press Releases