China Securities Regulatory Commission, Compilation Rules for Information Disclosures by Companies That Offer Securities to the Public No. 25: Guidelines for the Content and Format of Prospectuses of Companies That Engage in Pharmaceutical and Medical Device Business

Issued: July 29, 2022

Effective: as of date of issuance

Applicability: For the purposes of these Guidelines, the term "pharmaceutical and medical device business" means engagement in the pharmaceutical and medical device research, development, production and sales business, but excludes production of active pharmaceutical ingredients, outsourcing services for pharmaceutical industry (CRO, CMO, CDMO, etc.), pharmaceutical distribution business, etc. Where the revenue or net profit derived by an issuer and its controlled subsidiaries from engaging in pharmaceutical and medical device business accounts for at least 30% of the company's operating revenue or net profit on its audited consolidated financial statements for the most recent fiscal year or where the issuer and its controlled subsidiaries chiefly engage in pharmaceutical and medical device business, have yet to generate sales revenue but the main products under research belong to pharmaceuticals or medical devices, the issuer shall perform its information disclosure obligations in accordance herewith (Article 3).