The Environmental Protection Department said it does not tolerate concrete batching plants operating without a licence and will make every effort to stop any illegal operations. The department made the statement in response to media reports yesterday of a concrete batching plant at 20 Tung Yuen Street in Yau Tong continuing to operate without holding a valid Specified Process Licence (SPL). The department has been closely monitoring the operation of two plants, both owned by China Concrete. The other plant is at 22 Tung Yuen Street in Yau Tong. Regarding the plant at 20 Tung Yuen Street, the Air Pollution Control Appeal Board dismissed an appeal lodged by China Concrete against the department’s refusal of its application for renewal of an SPL for the plant on November 22. Under the Air Pollution Control (Specified Processes) Regulations, the plant’s SPL ceased to be valid with immediate effect and the department issued a letter requesting that all works be halte
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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