– Advanced therapy products regulated


The Department of Health today said the Pharmacy & Poisons Board of Hong Kong earlier issued a licence to authorise a local company to manufacture autologous chimeric antigen receptor T cells, ie CAR-T cells, for clinical trial, but not for clinical treatment.


The department and the Hospital Authority today issued a joint statement in response to media enquiries about the issuance of a licence for a manufacturer of advanced therapy products by the board.


The statement said the board issued a licence for a manufacturer on August 30 according to the Pharmacy & Poisons Regulations, authorising the company to manufacture CAR-T cells for clinical trials.


It stressed that the licence specified that the company is authorised to manufacture CAR-T cells only for the purpose of clinical trials instead of any clinical treatment purpose.


In Hong Kong, advanced therapy products are regulated under the Pharmacy & Poisons Ordinance as a pharmaceutical product. If the company wishes to manufacture CAR-T cells for clinical treatment purposes, it must first apply to the board to alter the licensing conditions.


The department said manufacturers of any CAR-T cells for treatment purposes should apply to the board for registration in accordance with the regulations, adding that the board will only approve the application if the product meets safety, efficacy and quality criteria.


It stressed that using CAR-T cells for clinical trials or treatment purposes without approval is illegal and may be considered as a criminal offence.  


On the treatment side, the Hospital Authority pointed out that it began its CAR-T cell therapy pilot programme at Queen Mary Hospital in 2021, adding that the service has been extended to Hong Kong Children’s Hospital and Prince of Wales Hospital.


It is now prescribing Tisagenlecleucel for CAR-T cell therapy. The drug has been registered for clinical use for two indications, namely patients up to 25 years of age with B-cell acute lymphoblastic leukaemia that is refractory, in relapse post-transplant or in second or later relapse, or adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.


Currently, Tisagenlecleucel is the only CAR-T cell therapy drug registered in Hong Kong for clinical use, and it is not manufactured by the pharmaceutical product manufacturer licensed on August 30, the authority noted.


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