Hong Kong Approves Four New Drugs Under Accelerated "1+" Mechanism, Including IgA Nephropathy Treatment
核心洞察
Hong Kong has approved four new drugs under its accelerated "1+" approval mechanism, including a treatment for primary immunoglobulin A nephropathy (搜索) and therapies for thyroid eye disease (搜索), cervical cancer, and severe hemophilia.
Since implementation in November 2023, the "1+" mechanism has approved 15 new drugs total, with seven already listed in the Hospital Authority (搜索) Drug Formulary.
The mechanism allows new drugs to gain Hong Kong approval with support from just one reference regulatory authority instead of two, significantly streamlining the approval process.
Hong Kong's Department of Health has approved four additional new drugs under its streamlined "1+" approval mechanism, bringing innovative treatments for rare and serious conditions to patients faster than traditional regulatory pathways would allow.
The most recent approval, announced October 31, 2025, covers a new drug specifically designed to reduce proteinuria (搜索) in patients with primary immunoglobulin A nephropathy (搜索). This approval follows three other drugs approved in August 2025 for treating thyroid eye disease (搜索), recurrent or metastatic cervical cancer (搜索), and severe hemophilia A (搜索) or B.
Accelerated Approval Framework Shows Strong Results
The "1+" mechanism, implemented on November 1, 2023, represents a significant shift in Hong Kong's drug approval strategy. Originally designed for life-threatening or severely debilitating diseases, the program expanded in November 2024 to include all new drugs, encompassing new chemical or biological entities, new indications, vaccines, and advanced therapy products.
Under this system, pharmaceutical companies can secure Hong Kong registration by submitting approval from one reference drug regulatory authority, rather than the previously required two. All four recently approved drugs received their initial approval from the United States drug regulatory authority before applying through Hong Kong's "1+" pathway.
The Registration Committee under the Pharmacy and Poisons Board of Hong Kong evaluated clinical data and relevant information submitted by applicants, along with advice from local experts, before determining that the new drugs satisfied safety, efficacy, and quality criteria.
Growing Industry Interest and Adoption
Since launching the "1+" mechanism, Hong Kong has approved a total of 15 new drugs under this accelerated pathway. Seven of these approved drugs have already been incorporated into the Hospital Authority (搜索) Drug Formulary, making them accessible to patients within the public healthcare system.
The program has generated substantial pharmaceutical industry interest, with the Department of Health receiving more than 630 inquiries from over 160 pharmaceutical companies, including overseas and Mainland Chinese firms. Many companies have expressed specific interest in submitting applications for advanced therapy products under the extended "1+" mechanism.
To support this growing interest, the Department of Health launched a pre-new drug application consultation service in March 2025, conducting multiple briefing seminars and workshops. The department plans to introduce pre-new drug application meetings in the fourth quarter of 2025 to further enhance application processing efficiency.
Transition to Primary Evaluation System
Hong Kong's regulatory evolution extends beyond the current "1+" mechanism toward establishing independent drug evaluation capabilities. The government announced plans to establish the Hong Kong Centre for Medical Products Regulation (搜索) by the end of 2025, with "primary evaluation" for new drug registration beginning in phases next year.
Primary evaluation represents a fundamental shift that would allow Hong Kong to directly approve drug and medical device registration applications based on clinical data generated locally, eliminating reliance on other drug regulatory authorities. The Department of Health aims for full implementation of primary evaluation by 2030.
This regulatory transformation aligns with Hong Kong's broader strategic goal of becoming an international health and medical innovation hub. The accelerated drug approval processes are designed to provide momentum for healthcare industry development across Hong Kong, the Mainland, and international markets.
Clinical Impact and Patient Access
The approved treatments address significant unmet medical needs across multiple therapeutic areas. The IgA nephropathy treatment specifically targets proteinuria (搜索) reduction, a critical clinical endpoint for patients with this progressive kidney disease. The other approved therapies cover rare conditions including thyroid eye disease (搜索) and severe bleeding disorders, along with advanced cancer treatments.
By streamlining the approval process while maintaining rigorous safety and efficacy standards, Hong Kong's "1+" mechanism enables faster patient access to innovative therapies that have already demonstrated clinical benefit in major regulatory jurisdictions. The integration of approved drugs into the Hospital Authority (搜索) Drug Formulary further ensures that these advanced treatments reach patients through the public healthcare system.