HKEX Chapter 18A: How Does a Core Product Differ From Approval to Sell?

Start With Three Different Rule Definitions

Under Rule 18A.01 in the current Chapter 18A rules, a Regulated Product requires evaluation and approval by a Competent Authority, based on human clinical-trial data under applicable laws, rules or regulations, before it can be marketed and sold in that authority's market. A Core Product is a Regulated Product that, alone or with other Regulated Products, forms the basis of a biotech company's Chapter 18A listing application.

An Approved Product has a separate definition: a Biotech Product approved for commercialisation by a Competent Authority. These are not interchangeable marketing labels. An internally prioritised research project or a technology described in the press as central to the business does not qualify merely because of that description. Equally, the Core Product label alone does not establish approval to sell.

The rules name the US FDA, China's National Medical Products Administration and the European Medicines Agency as Competent Authorities. They also allow the Exchange, at its discretion and depending on the product, to recognise another national or supranational authority in an individual case. Evidence relating to one market cannot simply be treated as another market's required approval.

Read Clinical and Regulatory Milestones Together

The currently linked Guide for New Listing Applicants, Chapter 2.3, requires at least one Core Product to have progressed beyond the concept stage. It sets out clinical-trial and regulatory milestones for different product categories. A patent, prototype, paper or persuasive demonstration is not a substitute for this analysis.

For a new drug, the guide specifies completion of Phase I and no objection from the Competent Authority to starting Phase II or a later phase. Drugs based on previously approved products, biosimilars and combined-phase trials have additional guidance. Reducing all of these cases to “Phase I completed” would lose important conditions. A drug Core Product also brings a requirement concerning a pipeline of potential Biotech Products.

For medical devices, including diagnostic devices, the usual pathway addresses a Class II or higher device under the relevant Competent Authority's or Authorised Institution's classification, completion of at least one clinical trial, and no objection to the next phase of trials or device sales. Classification, a possible downgrade, regulatory communications and case-specific provisions must be read together. This article does not classify a particular device or treat ethics approval, laboratory testing or research findings as a sales authorisation.

An In-Licensed Product Needs More Than a Signed Agreement

For an in-licensed or acquired Core Product, the guide generally requires the applicant to have independently completed at least one clinical trial after obtaining it. Where no trial has been completed, the Exchange assesses the reasons and whether substantive R&D and other work equivalent to a trial have been undertaken. That is not an automatic exemption. The guide also addresses independent R&D progress after in-licensing or acquisition.

The useful preparation therefore goes beyond an agreement's signature page. Product, research and legal teams should reconcile who conducted which trials, what the applicant has done since acquiring rights, which indications and territories it retains, who controls further development, and who owns independently developed IP. This is an editorial approach to organising evidence, not a new Exchange form or a legal interpretation of a particular licence.

Separate the Funding Narrative From Product Status

The following table is an editorial working aid, not an exhaustive application checklist. Missing evidence should remain a question for professional review rather than becoming a completed milestone in a presentation.

Use consistent product identifiers across presentations, development records, licence materials and budgets. Evidence for one drug indication, device use or territory should not become a claim covering an entire platform, every use or worldwide rights.

Product Milestones Do Not Replace Company-Level Conditions

Rule 18A.03 also addresses an initial market capitalisation of at least HK$1.5 billion at listing, at least two financial years in the current business under substantially the same management, and sufficient working capital covering at least 125% of specified costs for at least 12 months. That period starts on publication of the listing document, taking IPO proceeds into account. R&D costs must be included even when capitalised. Capital expenditure, and interest and repayments where it is debt-financed, have specific treatment. Dividing a cash balance by monthly spending is not by itself a compliant calculation.

Chapter 2.3 also addresses continuing R&D, the purpose of the fundraising, IP and sophisticated-investor considerations, while retaining case-specific assessment. This is not a complete eligibility summary. One product result, a prominent investor or a private valuation cannot determine whether a company can submit an application or list. Chapter 18A is also distinct from the Chapter 18C Commercial Company revenue classification; their thresholds should not be combined.

For University and Greater Bay Area Teams, Identify Who Owns Each Question

When university research moves into a company, scientific evidence, licensing rights, clinical development, production preparation and fundraising communications may sit with different people. Permission to conduct research is not permission for every commercial use. Engineering work planned in Shenzhen does not replace the target market's regulatory requirements. An initial non-confidential statement of product scope and stage can help identify which questions belong with the technology-transfer office, regulatory specialists, lawyers and sponsors.

Jimhang Capital was founded by Justin Zhan. Teams working across Hong Kong and the Greater Bay Area can discuss non-confidential project communication, the organisation of research and industry questions, and preparation for capital conversations; the scope of any support needs separate confirmation. This does not imply that Jimhang Capital is a sponsor or regulatory adviser, or has relevant individual-case experience. It does not promise funding, approval or listing. An initial email to justin@jimscapital.cn can describe the product category, present stage and question without sending patient information, full trial datasets or private agreements.

Rule 18A.05 itself requires a prominent warning that a Core Product may not ultimately be successfully developed and marketed. Retaining that uncertainty is more useful than presenting Core Product status as a success guarantee. Public filing evidence is a separate question, discussed in Reading Hong Kong Listing Progress.

Sources checked on 2 November 2026 using the rule chapter and Chapter 2.3 guide actually linked by HKEX's current directories. This is not a new policy announcement or a report of an individual company's listing progress. It is editorial research, not a personal statement by Justin Zhan, medical or legal advice, or an individual investment recommendation. Product classification, eligibility and application arrangements require appropriate professional and authority confirmation.