Alert May 12, 2020
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Hong Kong Stock Exchange Issues New Guidance for Listing Pre-Revenue Biotech Companies

香港联合交易所发布有关未有收益生物科技公司赴港上市的新指引

Since the introduction of a new listing regime on 30 April 2018 that enables the listing of pre-revenue Biotech Companies[1] on the Main Board of the Hong Kong Stock Exchange (the “Exchange”), a total of 16 of these listings have completed. After reviewing Chapter 18A of its Main Board Listing Rules (“Chapter 18A”), the Exchange updated two earlier guidance letters (HKEX-GL92-18 and HKEX-GL85-16) to clarify its positions on certain issues relating to the listing suitability of Biotech Companies and the subscription by existing shareholders in Chapter 18A IPOs. The Exchange also published a new guidance letter (HKEX-GL107-20) on 29 April 2020 to provide further guidance on disclosures in listing documents for listing applicants under Chapter 18A.

This client alert highlights the Exchange’s key supplemental guidance and its effect on:

  • Application of the “beyond concept stage” and 12-months R&D listing suitability criteria for in-licensed or acquired Core Products of a listing applicant

  • Assessment of the suitability criteria for listing applicants with commercialized Core Products, medical device products, or “Other Biotech Product” without any regulatory or external milestones

  • Rights of participation by existing shareholders in Chapter 18A IPO

  • Grant of clawback waivers to listing applicants under Chapter 18A

  • Enhanced prospectus disclosure requirements in a listing applicant’s competitive landscape, communications with regulating authorities, pipeline products, and valuation and background of pre-IPO investments

  • Specific prospectus disclosure requirements for listing applicants with commercialized core products, orphan medicines or innovative therapies

Updated Guidance Letter HKEX-GL92-18 on Suitability for Listing of Biotech Companies

Additional guidance for Biotech Companies with in-licensed or acquired products

  • To demonstrate that the in-licensed or acquired Core Product has developed beyond the concept stage[2], a listing applicant should have completed at least one regulated clinical trial on human subjects since the in-licensing or acquisition. If not, the Exchange will evaluate the reason for absence of such trial and whether substantive R&D work and processes equivalent to one clinical trial on human subjects have been performed by the listing applicant, but administrative process will not be considered as substantive R&D work.

  • To demonstrate engagement in R&D of its in-licensed or acquired Core Products for at least 12 months before listing[3], a listing applicant under Chapter 18A must show R&D progress since the in-licensing or acquisition, which could be from preclinical to clinical stage; from one phase of clinical trial to the next; or obtaining regulatory approval from Competent Authority to market the product.

Additional guidance for Biotech Companies with commercialized products

For Core Products already commercialized in a given market for specified indications, and if the listing applicant will use a significant portion of the listing proceeds to expand the indications of such product or launch it in another market, the 12-months’ R&D listing requirement would be met if the listing applicant has expended on further R&D for clinical trials required by the Competent Authority to bring the commercialized Core Product for a new indication or a new regulated market.

Additional guidance for medical device companies

For listing applicants that develop medical devices to demonstrate that their primary reason for listing is raising funds for R&D to commercialize its Core Products[4], the Exchange may take into account the applicant’s business plan and pipeline development stage such that a portion of the listing proceeds could be allocated to set up production facilities for the manufacturing of its Core Products, and establish sales, marketing and medical teams for the commercialization of its Core Products.

Additional guidance for Biotech Companies with products not falling into any regulatory regime on external milestones  

For Biotech Products that do not fall within the three main categories (i.e. pharmaceutical, biologics and medical devices) for a Chapter 18A listing, and if there is no regulatory regime setting out external milestones or objective framework to assess the products’ development progress, market and clinical relevance, the Exchange will now consider (i) data from preclinical and clinical trials and the number, selection process and diversity of test sampling population; (ii) time-frame and impediments to commercialization; (iii)  the impact factor of any publication of the pre-clinical and clinical results in medical/scientific journals; and (iv) any relevant guidelines, comparable framework or objective indicators and the related views published by Competent Authorities.

The Exchange will only follow the categorization of a Biotech Product as categorized by the relevant Competent Authority, and the listing applicant cannot reclassify its product as “Other Biotech Product” because of failure to meet the listing requirements within its regulated category.

Additional guidance for existing shareholders’ participation in the IPO

Existing shareholders of a listing applicant with less than 10% shares may subscribe for IPO shares as a cornerstone investor or a placee, whereas a 10%+ existing shareholder may only participate in the IPO as a cornerstone investor. Existing shareholders may exercise any pre-IPO contractual anti-dilution right and subscribe for shares in the Chapter 18A IPO, which aligns with the Exchange’s guidance for special rights of pre-IPO investors in IPOs outside Chapter 18A.

Additional guidance on the clawback mechanism

The Exchange is mindful of the additional potential risks of Biotech Companies to retail investors and, at the same time, the popular demand by these investors in recent Chapter 18A IPOs. In order to balance such risks and investment sentiments, if the Hong Kong retail-tranche of a Chapter 18A IPO is highly over-subscribed, the Exchange will consider a proposal to adjust the clawback mechanism on a case-by-case basis and modify the minimum public/retail subscription requirement under PN18 of the Listing Rules, but only if compelling reasons are provided. While the Exchange has not set out further factors to grant such modifications (such as minimum offering size), such discretion by the Exchange would at least facilitate greater flexibility in the allocation to reflect demands for Chapter 18A IPOs.      

New Guidance Letter HKEX-GL107-20 on Disclosure in Listing Documents for Biotech Companies

A more concise summary for retail investors

Since Biotech Companies have attracted significant interest from retail investors who may not possess deep knowledge of biotechnology and medical science, a listing applicant under Chapter 18A should:

  • Make disclosures on scientific descriptions and data in the Summary section of the prospectus more readable and understandable by using plain language without compromising scientific accuracy. Meaningful headings and sub-headings, and cross-referencing to the Business section of the prospectus for technical contents should also be used

  • Ensure that the development timetable of its Core Products[5] is disclosed in a fair and balance manner, and include a risk factor that potential investors may lose all of their investments in an R&D failure of the listed issuer

A more comprehensive description about the competitive landscape

A listing applicant under Chapter 18A should disclose in the prospectus (i) a comparison between its products and direct competing products by technologies, indications and targeting market; (ii) the competitive landscape of its Core Products and key pipeline products to be commercialized in targeted markets (including name and price of competitors’ pipeline products targeting same indication, their IP expiration and reimbursement coverage); and (iii) material information on the relevant addressable markets, rather than overall market size, of Core Products and key pipeline products.

Specific disclosure about product development and commercialization

A listing applicant under Chapter 18A should also disclose in the prospectus the following about the development and commercialization of its Core Products and pipeline products: 

  • A summary of all important communications with and any material concerns raised by the relevant Competent Authorities[6] (e.g. the China National Medical Products Administration) on the clinical trials, or, if there is no such communications, a negative statement to such effect

  • If a portion of the listing proceeds is to be used to expand the specified indications or market of any commercialized Core Product, a breakdown of funds to support R&D and their importance in advancing the Core Product

  • For Core Products or key pipeline regulated as orphan medicines and/or innovative therapies, information on (i) basis to qualify in a regulatory pathway, exemptions granted under such classification and the advantages of approval under such designation; (ii) commercialization plan, regulatory and marketing strategies, timeline of the next regulatory milestones until NDA; and (iii) details of any collaboration with research institutes, including its background, material terms and conditions and IP ownership allocations

  • Information on the development of pipeline products by way of a Pipeline Table, including whether (i) they are in-licensed or self-developed and the jurisdiction rights; (ii) the listing applicant will prioritize any strategically or commercially critical products for development; and (iii) a significant portion of the listing proceeds will be applied for concept stage pipeline products, along with material information on relevant studies and data

Specific disclosure about financial position 

A listing applicant under Chapter 18A should also disclose in the prospectus information on (i) the valuation of each round of pre-IPO investments and any material fluctuations in valuation against the immediate previous round with reference to development of products business and competitive advantages; (ii) material information on the background and biotech track record of Sophisticated Investors[7]; (iii) any net liabilities during the Track Record Period from significant change in fair value of convertibles to be converted upon listing into a net assets position; (iv)  “capital burn rate” for maintaining viability with and without listing proceeds within a reasonable period and (v) timetable for next round of financing based on such burn rate.



[1] According to Chapter 18A, “Biotech Company” means a company primarily engaged in the research and development, application and commercialization of Biotech Products, and “Biotech Products” means biotech products, processes or technologies.

[2] Section 3.2(a) of HKEX-GL92-18 provides that a Biotech Company must have developed at least one Core Product beyond the concept stage, namely that it has met the developmental milestones specified for the relevant type of product.

[3] Section 3.2(c) of HKEX-GL92-18 provides that the Biotech Company must have engaged in R&D of its Core Product(s) for a minimum of 12 months prior to listing.

[4]Section 3.2(d) of HKEX-GL92-18 provides that the Biotech Company must have as its primary reason for listing raising funds for R&D to bring its Core Product(s) to commercialization.

[5] According to Chapter 18A, “Core Product” means a Regulated Product that (alone or together with other Regulated Products) forms the basis of a Biotech Company’s listing application under Chapter 18A, and “Regulated Product” means a Biotech Product  required by applicable laws to be evaluated and approved by a Competent Authority based on data derived from clinical trials (i.e. on human subjects) before it could be marketed and sold in the market regulated by that Competent Authority.

[6] According to Chapter 18A, “Competent Authority” means the U.S. Food and Drug Administration, the China Food and Drug Administration, the European Medicines Agency. The Exchange may, at its discretion, recognize other national or supranational authorities as a Competent Authority (depending on the nature of the Biotech Product).

[7]According to HKEX-GL92-18, the Exchange considers an investor as a  “Sophisticated Investor” by reference to factors such as its net assets or assets under management, relevant investment experience, and the investor’s knowledge and expertise in the relevant field.

自2018年4月30日引入新的上市制度以来,未有收益的生物科技公司[1] 可以在香港联合交易所(简称“联交所”)主板上市,迄今已有16家此类公司登陆联交所。联交所在审视《主板上市规则》第18A章(简称“第18A章”)后,联交所更新了两份指引信(HKEX-GL92-18和HKEX-GL85-16),以阐明其在关于生物科技公司是否适合上市以及现有股东在第18A章IPO中认购股份的相关问题上的立场。此外,联交所于2020年4月29日还发布了新的指引信(HKEX-GL107-20),为第18A章项下的上市申请人就上市文件中的披露事宜提供进一步指引。

本客户简报将从以下各方面阐述联交所补充指引的重点:

  1. “通过概念阶段”和12个月研发期的上市适合性标准在上市申请人经外购许可或购买的核心产品上的应用;

  2. 评估适合性标准分别对具有已商业化的核心产品、医疗器材产品或未有监管或外部目标的“其他生物科技产品”的上市申请人的适用;

  3. 现有股东在第18A章首次公开招股时的股份认购权利;

  4. 对第18A章项下的上市申请人授予回拨豁免;

  5. 在招股说明书中加强披露上市申请人的竞争形势、与主管当局的沟通、管线产品以及IPO前投资的估值和背景的要求;和

  6. 上市申请人的已商业化核心产品、罕见病药物或创新疗法在招股说明书中的具体披露要求。

关于生物科技公司是否适合上市的更新版指引信HKEX-GL92-18

针对获得外购许可或购得产品的生物科技公司的附加指引

  1. 为证明获得外购许可或购得的核心产品已通过概念阶段[2],上市申请人应自获得外购许可或购买以来已完成至少一项受监管的人体临床试验。否则,联交所将评估未进行此类试验的原因,以及上市申请人是否已进行了相当于一项人类体临床试验的实质性研发工作和程序,但行政报批过程将不被视为实质性研发工作。

  2. 为证明其在上市之前至少已投入12个月对获得外购许可或购得的核心产品进行研发[3],第18A章项下的上市申请人必须展示自获得外购许可或购买以来的研发进展,可以是从临床前到临床阶段;从一个阶段的临床试验到下一个阶段;或取得主管当局的监管批文以销售该产品。

针对具有已商品化产品的生物科技公司的附加指引

对于已经在特定市场中用于特定适应症的已商业化核心产品,如果上市申请人将使用上市所得款项的很大一部分来扩大该产品的适应症或在其他市场上推出该产品,且上市申请人已围绕主管当局的临床试验要求花费资金进一步研发,以将已商业化的核心产品用于新的适应症或于新的受监管市场上推出,那么可以被认为满足12个月研发时长的上市要求。

针对医疗器材公司的附加指引

对于开发医疗器材的上市申请人,为证明其申请上市的主要原因是筹集资金用于研发以将其核心产品[4]商业化,联交所可能会考虑申请人的业务计划和管线产品的开发阶段,以使部分上市所得款项可被用作设立用于生产核心产品的生产设施,并建立商业化核心产品所需的销售、市场推广和医疗团队。

针对产品不属于任何监管制度下的里程碑范围内的生物科技公司的附加指引

对于不属于第18A章列出的三个主要类别(即药剂、生物制剂和医疗器材)的生物科技产品,如果没有监管制度规定外部目标或客观框架来评估产品的开发进度、市场和临床相关性,联交所现在将考虑(i)来自临床前和临床试验的数据以及测试抽样人群的数量、筛选过程和多样性;(ii)推出市场的时限和障碍;(iii)如临床前和临床结果有在任何医学/科学期刊发表,該医学/科学期刊的影响因素;和(iv)主管当局发布的任何相关准则、可比框架或客观指标以及相关观点。

联交所只会按照相关主管当局对生物技术产品的分类,并且上市申请人不得由于未能满足其受监管类别内的上市要求而将其产品重新分类为“其他生物技术产品”。

对现有股东参与首次公开招股的附加指引

持有上市申请人股份少于10%的现有股东可以作为基础投资者或承配人认购首次公开招股的股份,而持股超过10%的现有股东只可以作为基础投资者参与首次公开招股。现有股东可行使任何首次公开招股前反摊薄合约权利并认购第18A章首次公开招股的股份,这与联交所关于第18A章以外的首次公开招股中的首次公开招股前投资者享有的特殊权利的指引相一致。

有关回拨机制的附加指引

联交所注意到生物科技公司给散户投资者带来的额外潜在风险,同时也关注到这些投资者在近期第18A章首次公开招股中的普遍需求。为了平衡此类风险和投资热情,如果第18A章首次公开招股中面向散户发行的部分获得了超额认购,而且在公司提供了具有说服力的原因的前提下,联交所将会根据具体情况逐例考虑调整回拨机制并修改《上市规则》第18号公告下最低公开/零售认购要求。尽管联交所没有列出更多同意此类修改(例如最小发行规模)的因素,但联交所的这一裁量权至少有利于增加分配的灵活性,以反映市场对第18A章首次公开招股的需求。

有关生物科技公司上市文件披露的新指引信HKEX-GL107-20

针对散户投资者的更简练的概要

由于生物科技公司吸引了可能不具备生物科技和医学知识的散户投资者的极大兴趣,因此第18A章项下的上市申请人应:

  1. 在不降低科学准确度的前提下,在招股说明书的“概要”章节使用简单浅白的语言对科学描述和数据予以披露,使其更具可读性、易于理解。还应使用有意义的标题和副标题,并交叉引用招股说明书的“业务”章节以阐释技术性内容; 和

  2. 确保以公正平衡的方式披露其核心产品[5]的研发时间表,并提示潜在投资者可能因上市发行人的研发失败而损失其所有投资这一风险因素。

对竞争形势更全面的描述

第18A章项下的上市申请人应在招股说明书中披露(i)其产品与直接竞争产品在技术、适应症、目标市场的比较;(ii)其核心产品及其他主要管线产品在拟推出目标市场的竞争形势(包括针对相同适应症的竞争对手管线产品的名称和价格、其专利届满日期和报销保障);和(iii)其核心产品和主要管线产品所在的相关目标市场而非整体市场的重要信息。

对产品开发和商业化的详细披露

第18A章项下的上市申请人还应在招股说明书中披露以下有关其核心产品和管线产品的开发和商业化信息:

  1. 与有关主管当局[6](如中国国家药品监督管理局)进行的关于临床试验的所有重要通讯的概要,以及主管当局对此提出的任何重大疑虑;或者,如果没有此类通讯,则亦如实说明;

  2. 如果一部分上市所得款项将用于拓展任何已商业化的核心产品的特定适应症或市场,则应披露用于支持研发的资金明细及其对推进核心产品的重要性;

  3. 对于被归类为罕见病药物和/或创新疗法的核心产品或关键管线,则披露(i)相关药物符合某一监管途径的基准、该监管分类下所获得的豁免、以及按此途径取得批准的好处;(ii)商业化计划、监管和市场策略、到新药上市许可(NDA)为止的后续监管里程碑的时间表;和(iii)与任何研究机构合作的细则,包括合作背景、重大条款细则、以及知识产权的权利分配;和

  4. 以管线产品列表的形式概述管线产品开发的信息,包括(i)这些产品是外购许可还是内部开发的产品以及复盖市场;(ii)上市申请人是否将优先考虑开发任何具有战略或商业重要性的产品;和(iii)是否将上市所得款项的很大一部分用于概念阶段的产品,以及相关研究和数据的重要信息。

对财务状况的详细披露

第18A章项下的上市申请人还应在招股说明书中披露以下信息:(i)IPO前每轮融资的估值,并参照产品业务发展和竞争优势对较之前一轮估值出现的任何重大波动作出说明;(ii)关于资深投资者[7]的背景及其在生物科技领域投资业绩记录的重要信息;(iii)业绩记录期内因可转债将在上市时转换为净资产导致公允价值出现重大变化而产生的任何净负债;(iv)“资本消耗率”,即在合理期限内在有或没有上市所得款项的情况下维持生存能力;和(v)根据资本消耗率拟定的下一轮融资时间表。



[1] 根据第18A章,“生物科技公司”是指主要从事生物科技产品研发、应用或商业化发展的公司,其中“生物科技产品”是指生物科技产品、流程或技术。

[2] HKEX-GL92-18的第3.2(a)节规定,生物科技公司必须至少已开发出一项通过概念阶段的核心产品,即该产品已达到针对相关类型产品所指定的发展进度目标。

[3] HKEX-GL92-18的第3.2(c)条规定,生物科技公司必须在上市前从事其核心产品的研发至少12个月。

[4] HKEX-GL92-18的第3.2(d)节规定,生物科技公司必须将募集资金用于研发核心产品以使其实现商业化作为上市的主要理由。

[5] 根据第18A章,“核心产品”是指(单独或连同其他受规管产品)作为生物科技公司根据第18A章申请上市基础的受规管产品,其中“规管产品”是指适用法律、规则及规例订明须经主管当局根据临床试验(即人体试验)数据评估及批准方可在主管当局所规管市场营销及发售的生物科技产品。

[6] 根据第18A章,“主管当局”美国食品及药物管理局、中国国家食品药品监督管理总局及欧洲药品管理局。联交所可(取决于生物科技产品的性质)酌情视另一国家级或超国家级的机关为主管当局。

[7] 根据HKEX-GL92-18,联交所会参考诸如其净资产或管理资产净值、相关投资经验,以及投资者在相关领域的知识和专长等因素,来考虑将投资者视为“资深投资者”。