The Hong Kong Special Administrative Region (HKSAR) Government has approved two new oral drugs for the treatment of hypercalcemia in patients with parathyroid carcinoma and certain patients with primary hyperparathyroidism. The approvals were granted under the "1+" mechanism, which aims to accelerate the registration of new drugs for life-threatening or severely debilitating diseases.
The "1+" mechanism, introduced in November 2023, allows new drugs supported by local clinical data to be registered in Hong Kong based on approval from just one drug regulatory authority in a recognized reference place, instead of the original requirement of two. This initiative is part of a broader effort to establish Hong Kong as an international health and medical innovation hub.
The newly approved drugs for hypercalcemia had already been approved by the drug regulatory authority in Japan. The Registration Committee under the Pharmacy and Poisons Board of Hong Kong reviewed the clinical data submitted by the applicant and consulted with local experts. The committee determined that the drugs satisfied the stringent criteria for safety, efficacy, and quality, leading to their approval.
A government spokesman stated that the approval of these drugs will provide more treatment options for patients suffering from hypercalcemia related to parathyroid carcinoma and primary hyperparathyroidism. Hypercalcemia, characterized by elevated calcium levels in the blood, can lead to various complications, including kidney problems, bone weakness, and neurological issues.
Broader Impact of the "1+" Mechanism
Since its implementation, the "1+" mechanism has facilitated the approval of several other new drugs. In December 2023, two new drugs for treating metastatic colorectal cancer were approved, followed by another drug for paroxysmal nocturnal haemoglobinuria in July 2024. The drugs for metastatic colorectal cancer have been listed under the "Special Drug" category on the Hospital Authority (HA) Drug Formulary, significantly reducing the financial burden for patients who meet specific clinical criteria, with an estimated 300 patients benefiting annually.
The Department of Health (DH) has been actively promoting the "1+" mechanism and has received over 250 inquiries from more than 70 pharmaceutical companies, indicating growing interest in utilizing this expedited registration pathway. While the "1+" mechanism aims to accelerate access to new drugs, it also incorporates safeguards to ensure that all approved products meet rigorous safety, efficacy, and quality standards. The requirement for local clinical data and expert recognition ensures that the drugs are appropriate for the Hong Kong population and healthcare system.
Future Developments
The HKSAR Government plans to further leverage its medical strengths to establish an authority that directly approves applications for drug and medical device registration based on clinical trial data, without relying on approvals from other regulatory bodies. This "primary evaluation" approach will further accelerate the clinical use of new medical products and foster the growth of research and development activities in Hong Kong.
