Cross-referenced from Listing Rule 210(8) and Chapter 6

1. Introduction

1.1 This Practice Note sets out the prospectus disclosure requirements and guidance of what constitutes the successful development of products beyond the concept stage for life science companies seeking a listing on the Exchange.

2. Disclosure Guidelines

2.1 The issuer should disclose in its prospectus:

(1) Details of its operations in laboratory research and development, to the extent material to investors, including: 

(a) details of patents granted or details of progress of patent applications. Unless otherwise required under the Securities and Futures (Offers of Investments) (Securities and Securities-based Derivatives Contracts) Regulations 2018, such details need not be disclosed if disclosure would result in the issuer disclosing highly sensitive confidential information. In that case, the issuer must disclose the reasons for the non-disclosure; and 

(b) in relation to its identified products, details of the successful development of at least one of its identified products beyond the concept stage;

(2) Details of the relevant expertise and experience of its key management and technical staff;

(3) The salient terms of any service agreements between the issuer and its key management and technical staff;

(4) The safeguards and arrangements that the issuer has in place, in the event of the departure of any of its key management or technical staff;

(5) The risk and impact, financially or otherwise, from such departure of key management or technical staff on the group's business and operations;

(6) Information on whether the issuer has engaged in collaborative research and development agreements with other organisations, to the extent material to investors;

(7) A comprehensive description of each product, the development of which may have a material effect on the future prospects of the issuer;

(8) The directors' opinion which must state, without requiring a profit forecast, that in their reasonable opinion, the working capital available to the issuer, as at the date of lodgement of the prospectus, is sufficient for the present requirements and for at least 18 months after listing; and

(9) Where relevant and appropriate, an expert technical assessment and industry report.

3. Guidance on what constitutes the successful development of products beyond the concept stage

3.1 For the purposes of Rule 210(8)(d)(ii) and paragraph 2.1(1) above, the Exchange would consider a life science product to have been developed beyond the concept stage if it has met the milestones specified below for the product, including (a) pharmaceuticals (small molecule drugs), (b) biologics, and (c) medical devices (including diagnostics), as categorised by a competent authority:

(1) Drug (including pharmaceuticals and biologics): (a) Completed Phase I clinical trials for a new drug or at least one clinical trial for a drug based on a previously approved product or biosimilar, and (b) a competent authority has no objection to the commencement of Phase II (or later) clinical trials;

(2) Medical device (including diagnostic devices): (a) Completed at least one clinical trial for a Class II or above medical device (under the classification criteria of the relevant competent authority), and (b) a competent authority has no objection to commencement of the next phase of clinical trials, or sales of the device; and

(3) A life science product that does not fall under the “Drug” or “Medical device” categories based on the classification of a competent authority will be assessed on a case-by-case basis with reference to all relevant facts and circumstances, including whether (a) it has been developed beyond the concept stage by reference to the developmental milestones set out in paragraphs 3.1(1) and (2) above, and (b) there is an appropriate framework or objective indicators to enable investors to make an informed investment decision.

3.2 References to “competent authority” in paragraph 3.1 above means the Singapore Health Sciences Authority, the U.S. Food and Drug Administration, the China Food and Drug Administration, or the European Medicines Agency, as well as any other national or supranational authority that the Exchange may, at its discretion, consider as a competent authority for the purpose of paragraph 3.1 above (depending on the nature of the life science product). This also includes any institution, body, or committee duly authorised or recognised by, or registered with, a competent authority to conduct, assess, and supervise clinical trials in the relevant clinical fields.

Amended on 29 September 2011 and 29 October 2025.