Chapter 18A

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Question:

How is the market capitalization of shares held in the hands of the public ascertained for a biotech company?

Answer:

A biotech company listing under Chapter 18A must meet both Rule 8.08(1) and 18A.07.  For the purpose of Rule 18A.07, the applicant must ensure that it has at least HK$375 million of public float at the time of listing, which must exclude subscriptions by existing shareholders at IPO and subscriptions through cornerstone investments.

FAQ Series N/A, FAQ No. 040-2018
LR reference: Main Board Rules 8.08(1), 8.24, 18A.07
Released on 24/8/2018

Question:

Whether the Exchange would accept the clinical trials of a Biotech Product that are conducted by other authorities other than Competent Authorities under Chapter 18A (the Food and Drug Administration, the European Medicines Agency and China Food and Drug Administration?

Answer:

The Exchange may recognised other national or supranational authority on a case by case basis with reference to:

(i) whether such authority can be regarded or authorised as a comparable authority as to the Competent Authorities;
(ii) whether the approval process of that authority in relation to the Biotech Product in question is comparable to the process and expertise of a Competent Authority in terms of assessing the robustness of a Biotech Product; and
(iii)    whether there are precedent cases and the basis of other Biotech Products seeking such comparable authority for guidance or reference.

FAQ Series N/A, FAQ No. 036-2018
LR reference: Main Board Rules Chapter 18A
Released on 24/8/2018

Question:

What is the function of the Biotech Advisory Panel and the process in seeking its advice?

Answer:

The function of the members of the Biotech Advisory Panel is advisory only and members will be consulted by the Exchange, the Listing Committee or the SFC on an individual and "as needed" basis.

Please refer to the Exchange's announcement on 4 May 2018 at:
http://www.hkex.com.hk/News/News-Release/2018/1805042news?sc_lang=en

FAQ Series N/A, FAQ No. 037-2018
LR reference: Main Board Rules Chapter 18A
Released on 24/8/2018

Question:

What material information is expected to be disclosed in a listing document regarding a principal investigator (“PI”)note who is in charge of or supervising a biotech company’s clinical trial? (Note: PIs are usually contracted by contract research organisations to provide services to biotech companies)

Answer:

Where a PI who is in charge of or supervises a clinical trial of a biotech company has additional roles, such as acting as a member of scientific advisory panel, in a biotech company and receives compensation for such roles, the following disclosure is expected in the listing document:

(i) the PI’s specific functions in the biotech company and in terms of compensation, if any; and
(ii)    whether such compensation to the PI may impair the integrity of the biotech company’s clinical trial.

FAQ Series N/A, FAQ No. 039-2018
LR reference: Main Board Rules Chapter 18A
Released on 24/8/2018 (Updated in April 2020)

Question:

Could a biotech company with revenue and profit under Main Board Rule 8.05 be able to list under the Chapter 18A?

Answer:

No, a biotech company which is able to meet the financial eligibility requirements under Rule 8.05 cannot list under Chapter 18A.  In determining whether a biotech company is able to meet the financial eligibility requirements under Rule 8.05, the existing rules and guidance will be applied (for example, examining whether any revenue / profit is generated from activities outside the ordinary and usual course of its business).

FAQ Series N/A, FAQ No. 041-2018
LR reference: Main Board Rules Chapter 18A
Released on 24/8/2018