We generate substantially all of our revenues by providing our subscribers with processing services, which consist of the testing and processing of cord blood units, and storage services, which consist of the storage of cord blood units in our facilities. We sometimes refer the processing services and storage services collectively as "subscription services" in this report. In addition, we are also required by the PRC government to store cord blood units donated by the public and offer matching units to patients in need of transplants, which we sometimes refer to as the "matching services" in this report. All of these revenues for the years ended March 31, 2020, 2021 and 2022 were derived in China. Due to the lack of a clear, consistent and well-developed regulatory framework, operation in the cord blood banking industry in China involves significant ambiguities, uncertainties and risks. We cannot assure you that we can continue to operate our business in the same manner for the following reasons:
- "One license per region" policy
The NHC (formerly known as NHFPC) has been following a "one license per region" policy in its regulation of cord blood banks, which precludes more than one cord blood banking license holder from operating in the same region. According to the Notice on Extension of Time Limit on Planning and Establishment of the Cord Blood Bank published by the NHFPC in December 2015, the NHFPC extended the planning and establishment timetable for cord blood banking and would not grant any new licenses before 2020 in addition to the seven existing cord blood banking licenses; meanwhile, it plans to build the National Cord Blood Bank. On November 29, 2019, the NHC announced a Notice Regarding the Issuance of Free Trade Zone "Separating Permits from Business Licenses" Healthcare Reform Implementation Plan (the "New Policy"). Under the New Policy, the LHCs are allowed to approve cord blood banking licenses in 18 pilot Free Trade Zones ("FTZs") in China, namely Shanghai, Tianjin, Fujian, Guangdong, Liaoning, Zhejiang, Hubei, Henan, Chongqing, Sichuan, Shaanxi, Hainan, Shandong, Jiangsu, Guangxi, Hebei, Yunnan and Heilongjiang. The New Policy does not specify the implementation details, such as qualifications for applicants, license approval procedures or licensed region coverage, but it implies that the regulatory bodies could expand the current seven licensed regions for cord blood banking to up to 19 regions, including Beijing. As of September 24, 2020, this number had been increased from 18 FTZs to 21 FTZs in China, with three new FTZs including Beijing, Hunan and Anhui. Thus, the New Policy implies that the regulatory bodies could expand the current seven licensed regions for cord blood banking to up to 21 regions. On December 30, 2020, the NHC announced a Notice Regarding the Matters Related to Issuance of Cord Blood Banking License, which specified that no cord blood banking license applications shall be accepted in 2021.
On July 2, 2021, the NHC announced a Notice on Reform Measures for "Separating Permits from Business Licenses" in the Medical Field (the "2021 Policy") to specify the nationwide "Separating Permits from Business Licenses" reform measures in the medical field, including allowing online application for cord blood bank establishment and practice approval, and shortening the approval time limit. Meanwhile, the 2021 policy provides that the application procedure shall still be implemented in accordance with the Measures for Administration of Blood Stations; that is, the NHC was responsible for the approval of the establishment of cord blood banks and the LHCs were responsible for the practice approval. However, as of the date of this report, the NHC has not issued any notice on whether to accept the cord blood banking license applications nationwide.
If new licenses are issued in Beijing, Guangdong, Zhejiang or any region where we operate the licensed cord blood banks, or if the LHCs actually permit or acquiesce the operation of subscription service by other types of institutions, our market position as the sole cord blood banking operator in the relevant region may be undermined. Further, we may be required to record impairment charges in respect of some or all of the carrying values of the rights to operate our cord blood banks in Guangdong and Zhejiang, or our investment in Shandong, if additional licenses are issued in those regions or if the NHC or the relevant LHC takes the position that the provision of fee-based commercial cord blood banking services is not limited to operators of licensed cord blood banks. Any impairment charge that we may be required to record due to changes in regulatory policies could materially and adversely affect our assets and net income.
- Biosecurity Law
The Biosecurity Law of the People's Republic of China (the "Biosecurity Law") was passed by the Standing Committee of the PRC National People's Congress and took effect on April 15, 2021. The Biosecurity Law empowered the government to strengthen the regulation and supervision over multiple biological factors, including the biosecurity management of human genetic resources ("HGR") and biological resources. The Biosecurity Law also contains provisions that specifically address the collection (only for certain HGR defined under the Biosecurity Law), preservation, international research or export of HGR shall be subject to the prior approval of the Ministry of Science and Technology of the People's Republic of China ("MOST"), unless for the purposes of clinical diagnosis and treatment, for collection and supply of blood or for other purposes defined under the Biosecurity Law. Under the Biosecurity Law, any overseas organization, individual or any entity established or actually controlled thereby is not allowed to collect or preserve China's HGR in China, or provide China's HGR collected in China to regions outside of China. In the absence of further implementation details, there are significant ambiguities and uncertainties regarding the Biosecurity Law and how it will affect GCBC's operations. Given that GCBC is a Cayman company and GCBC's subscription services involve collection and storage of umbilical cord blood stem cells from subscribers and donors in China (which contains HGR), it is possible that the regulatory authorities will take the position that GCBC is in violation of the Biosecurity Law. If this is the case, we may be forced to cease our subscription and matching services; or be forced to modify our operations or apply for additional approvals in order to comply with the Biosecurity Law. As such, our operational, financial condition and share price would be materially and adversely affected.
- Antitrust Law
Our business may be exposed to increasingly stringent anti-monopolistic measures from the PRC government. Under the PRC Antitrust Law, the monopolistic activities are classified into (i) monopoly agreements, including both agreements entered into between business operators and suppliers and agreements between the operators; (ii) abuse of a dominant market position by business operators; and (iii) concentration of business operators that may have the effect of precluding or impeding competition. As of the date of this report, only seven cord blood banking licenses have been granted in China, three of which to the Beijing Cord Blood Bank, the Guangdong Cord Blood Bank and the Zhejiang Cord Blood Bank (all of which are operated by us) and a fourth to Qilu, the sole operator of the Shandong Cord Blood Bank, in which we own a 24.0% equity interest and our controlling shareholder owns a 76.0% equity interest. Therefore, we cannot assure you that we will not be identified as a business operator having a dominant market position. In the event of such circumstances, the antitrust authorities may impose more stringent supervision over our operations in China, in particular as to our ability in changing or modifying any parts of our operations. There is even a risk that subscription prices would become subject to compulsory or directory guidance or other restrictions imposed by PRC government. Further, we plan to expand our business through further strategic acquisitions. If the contemplated business concentration has the effect of precluding or impeding competition, the antitrust authorities may prohibit consummation of the contemplated business concentration or impose conditions that would lessen the impact of the concentration poses on competition, and we may therefore be unable to expand our business through acquisitions. In addition, our subsidiaries in Beijing, Guangdong and Zhejiang adopt similar commercial policies and share lots of material procurement channels in China. In the event that any agreement or a series of agreements entered into by us are identified as monopoly agreements, the profits generated from such agreements could be confiscated and we may be subject to administrative penalties.
- Provision of fee-based commercial cord blood banking services
Under the Measures for the Administration of Blood Stations issued by the MOH, or "the Measures", which became effective on March 1, 2006 and were amended in 2009, 2016 and 2017, respectively:
ofor-profit cord blood banks and other for-profit special purpose blood stations are not approved;oneither collection nor supply of cord blood from donors may be conducted for the purpose of making a profit;othe purchase and sale of cord blood units donated by the public is prohibited; and ocord blood banks are prohibited from collecting or providing cord blood without a duly obtained Blood Station Operation License issued by the provincial-level DOH or LHFPC or LHC.
Our Beijing, Guangdong and Zhejiang licenses were either renewed or issued by the relevant provincial-level DOHs, LHFPCs or LHCs after the Measures became effective on March 1, 2006.
The cord blood bank operated by Jiachenhong, our operating subsidiary in Beijing, obtained its first cord blood banking license from the MOH in September 2002. In September 2005, June 2007, March 2010 and April 2013, the MOH/DOH in Beijing renewed the license for the cord blood bank operated by us for an additional three years. In April 2016, the LHFPC in Beijing renewed the license for the cord blood bank operated by us for an additional nine years. The cord blood bank operated by Nuoya, our operating subsidiary in Guangdong, obtained its first cord blood banking license from the DOH in Guangdong in June 2006. In each of May 2009, May 2012, May 2015, May 2018 and April 2021, the DOH/LHFPC/LHC in Guangdong renewed the license for the cord blood bank operated by us for an additional three years. The cord blood bank operated by Lukou, our operating subsidiary in Zhejiang, obtained its first cord blood banking license from the DOH in Zhejiang in September 2010. In each of September 2013, September 2016 and September 2019, the DOH/LHFPC/LHC in Zhejiang renewed the license for the cord blood bank operated by us for an additional three years.
All the operators of the licensed cord blood banks in China have been providing fee-based commercial cord blood banking services to fee-paying subscribers in conjunction with cord blood banking services provided to the public with respect to donated cord blood units. We believe that the NHC and the LHCs in Beijing, Guangdong and Zhejiang are aware of fee-based commercial cord blood banking services in these regions, as they inspect cord blood bank facilities from time to time. In addition, our license application materials submitted to the LHFPCs/LHCs in Beijing, Guangdong and Zhejiang contained information about our subscription services to subscribers.
Although the above facts indicate that the NHC and the LHCs have been continuously supervising Beijing, Guangdong and Zhejiang cord blood banks, which collect cord blood units donated by the public and provide fee-based commercial cord blood banking services, there lacks a clear, consistent and well-developed regulatory framework for the cord blood banking industry in China as well as formal clarifications of policies or positions by the NHC and the LHCs on how they interpret, administer and enforce the regulations in light of the ambiguities under the current regulatory environment. In response to the development of China's medical reform, the PRC government may further promulgate certain guidance or compulsory regulations or clarify its policies or regulatory positions in other manners, which could undermine cord blood bank operator profitability by restricting or even prohibiting licensed cord blood banks or their operators from conducting fee-based commercial cord blood banking services. The PRC government may guide or force licensed cord blood bank to focus on its business of providing matching services or at least take matching services as its main business by imposing certain restrictive conditions on subscription services. We cannot assure you that the PRC government and the health authorities will continue their current regulatory practice and not prohibit the provision of for-profit subscription services. In the event that the PRC government and the health authorities change their regulatory position and prohibit companies or any other entities in China, including us, from operating for-profit subscription businesses or acting as operators of cord blood banks, we may have to terminate our business or change our business model. Further, if we were required to apply for a special or a separate permit, license or authorization for the provision of such services, we may have to suspend our business to apply for the special or a separate permit, license or authorization. We may be subject to administrative penalties and/or claims for operation without a license. There is no assurance that we will be able to obtain the license. We may be forced to shut down our business if we are unable to obtain the license. Also, there is no assurance that we will be able to apply for and obtain a new approval or license to expand our business.
The NHC or the relevant LHC may take the position that the provision of fee-based commercial cord blood banking services is not limited to operators of licensed cord blood banks. In the event that the NHC or the relevant LHC publicly announces such position, or clarifies such position in an implicit or explicit manner, other companies in healthcare or other related industries may begin to provide such services, in which case we will face direct competition from these companies.
If any of the above circumstances occur, our business and financial condition will be materially and adversely affected. Similarly, if the NHC or the relevant LHC orders the operator of the Shandong Cord Blood Bank to cease fee-based commercial cord blood banking operations, Qilu's operations will be severely affected, which in turn may materially and adversely affect our investment.
- Laws in relation to foreign investment
Our business may be materially and adversely affected if we are prohibited from providing collection, testing, storage and matching services in connection with cord blood under the Industrial Catalogue Guiding Foreign Investment, or the "Catalogue" and the Negative List.
Prior to December 1, 2007, foreign investments in China were subject to regulation by the Catalogue promulgated in November 2004 by the National Development and Reform Commission, or the "NDRC", and the Ministry of Commerce, or the "MOC". On October 31, 2007, the NDRC and the MOC revised the Catalogue, which became effective on December 1, 2007. The Catalogue was subsequently amended and revised by the NDRC and the MOC in 2011, 2015 and 2017. On June 28, 2018, the NDRC and the MOC promulgated the Special Administrative Measures for Access of Foreign Investment (Negative List) (the "Negative List") (2018 Edition), which entered into force from July 28, 2018, and superseded the categories of "restricted" and "prohibited" for foreign investment as provided in the Catalogue revised in 2017. On June 30, 2019, the NDRC and the MOC promulgated the Negative List (2019 Edition) and The Catalogue of Industries for Encouraged Foreign Investment (the "Encouraged Catalogue") (2019 Edition) which became effective on July 30, 2019, and the Negative List (2018 Edition) and the categories of "encouraged" for foreign investment as provided in the Catalogue revised in 2017 were repealed simultaneously. On June 23, 2020, the NDRC and the MOC promulgated the Negative List (2020 Edition) which became effective on July 23, 2020 and the Negative List (2019 Edition) was repealed. On December 27, 2020, the NDRC and the MOC promulgated the Encouraged Catalogue (2020 Edition) which became effective on January 27, 2021 and the Encouraged Catalogue (2019 Edition) was repealed. On December 27, 2021, the NDRC and the MOC promulgated the Negative List (2021 Edition), which became effective on January 1, 2022 and replaced the Negative List (2020 Edition).
On March 15, 2019, the National People's Congress promulgated The Foreign Investment Law of the PRC (the "FIL"), which became effective on January 1, 2020. According to the FIL, foreign investments are entitled to pre-entry national treatment and subject to negative list administration. Foreign investors (the "Foreign Investors") must not invest in any forbidden fields stipulated in the Negative List. Under the Catalogue promulgated in 2004, there were no prohibitions against investment by foreign enterprises in the cord blood banking industry in China. Under the Catalogue revised in 2007, 2011, 2015, 2017 and the Negative List (including the 2018 Edition, the 2019 Edition, the 2020 Edition and the 2021 Edition), however, foreign enterprises are prohibited from engaging in stem cell and gene diagnosis and treatment technology development and application. Since the Negative List still does not clearly define the scope of such prohibited business, it is uncertain whether it prohibits diagnosis and treatment technology development and application of stem cells only or it prohibits all stem-cell-related technology development and application. Therefore, it is unclear whether our cord blood banking services will be construed as a prohibited business under the Negative List.
We have consulted with our PRC counsel and found no evidence leading to the conclusion that the subscription services provided by our cord blood banks violate the Catalogue revised in 2007, 2011, 2015 and 2017 and the Negative List (including the 2018 Edition, the 2019 Edition, the 2020 Edition and the 2021 Edition). We have also communicated and consulted with the MOH/NHFPC/NHC and the relevant DOHs/LHFPCs/LHCs regarding the legality of cord blood banking services provided by our cord blood banks subsequent to the effectiveness of the Catalogue revised in 2007, 2011, 2015 and 2017 and the Negative List (including the 2018 Edition, the 2019 Edition, the 2020 Edition and the 2021 Edition). So far, neither the Company nor our cord blood banks have received any negative comment, query, notice of prohibition, notice of termination of the service, administration sanction or penalty due to the cord blood banking service being deemed non-compliant with the relevant PRC laws and regulations or in violation of the terms set forth in the blood station licenses. Moreover, all the annual inspections, payments of the registered capital and change of the legal representative of our PRC subsidiaries, after the Catalogue revised in 2007, 2011, 2015 and 2017 and the Negative List (including the 2018 Edition, the 2019 Edition, the 2020 Edition and the 2021 Edition) became effective, have been officially approved, registered and filed with the authorized Industry and Commerce Administration Bureau. Also, our Beijing Cord Blood Bank, Guangdong Cord Blood Bank and Zhejiang Cord Blood Bank renewed their cord blood banking licenses in April 2016, April 2021 and September 2019, respectively, with the relevant authorities, after the Catalogue revised in 2007, 2011, 2015, 2017 and the Negative List (including the 2018 Edition, the 2019 Edition, the 2020 Edition and the 2021 Edition) were already effective. None of Jiachenhong, the Beijing Cord Blood Bank, Nuoya, the Guangdong Cord Blood Bank, Lukou, or the Zhejiang Cord Blood Bank encountered any major obstacle, hurdle or query during the renewal process of the cord blood banking license or business license.
The Catalogue revised in 2007, 2011, 2015 and 2017 and the Negative List (including the 2018 Edition, the 2019 Edition, the 2020 Edition and the 2021 Edition) have no retroactive force, and foreign enterprises approved to operate in China before their businesses become prohibited under the Catalogue revised in 2007, 2011, 2015 and 2017 and the Negative List (including the 2018 Edition, the 2019 Edition, the 2020 Edition and the 2021 Edition) should be able to continue their businesses in accordance with the approvals they previously obtained. However, there is no assurance that such enterprises will continue to be able to renew their licenses if the government authorities consider that renewal of their licenses would contravene the Negative List. Moreover, we may not be able to obtain necessary approvals for our business expansion or acquisitions under the Negative List from the government authorities. We also may not be able to extend the operating periods of our existing PRC subsidiaries, including Jiachenhong, Nuoya and Lukou. Jiachenhong has an operating period of twenty years and the cord blood banking license is subject to renewal in May 2025. Nuoya has an operating period of thirty years and the cord blood banking license is subject to renewal in May 2024. Lukou has an operating period of twenty years and the cord blood banking license is subject to renewal in September 2022. The contracts between Jiachenhong, Nuoya and Lukou and their respective subscribers are typically for a period of 18 years. Effective from April 1, 2021, we provide further storage service with a contract period for 10 years or 20 years to subscribers who completed the first 18-year contract period. If Jiachenhong, Nuoya and Lukou are unable to extend their respective operating periods, these respective operating periods will not cover the period of the contracts entered into after September 2005, August 2019 and December 2012, respectively, and the relevant entities may have to be transferred to domestic companies or go into liquidation upon the expiration of their respective operating periods. In addition, after the Negative List is issued, we may not be able to obtain approval from the relevant authorities for increasing the registered capital of Jiachenhong, Nuoya and Lukou, subscribing to the increased registered capital of Jiachenhong, Nuoya and Lukou, or making contributions for such capital with foreign currency sourced from overseas. If any of the above factors occurs, we may be required to change our business model or otherwise cease our business operations.
- Other additional licensing requirements oThe NHC or the relevant LHC may take the position that the subscription services and the matching services cannot be operated by the same operator. In such circumstances, we may be required to obtain a separate or a special license, permit, or authorization for our subscription services, or may be subject to some restrictive conditions, in which case our operations will be materially and adversely affected.
oThe PRC government may adopt additional requirements for the licensing, permitting or registration of cord blood banking services. As a result of the ongoing healthcare reforms in China, and in view of the policies promulgated and published by the PRC government regarding the aforementioned healthcare reforms, including the Notice on Strengthening the Management and Control of Cord Blood Stem Cells published by the MOH on October 24, 2011, cord blood banks services may be subjected to pricing standards established by the relevant commodity price departments of the PRC. Moreover, on October 8, 2012, the State Council published a notice on the "Twelfth Five-Year Plan" of Health Care Development which suggests strengthening the safety and security of the blood stations, and improving the standards of the blood station laboratories, and on December 3, 2012, the MOH published three industrial standards including "Requirements for Blood Storage" which may be related to our cord blood banking service management. Notwithstanding, there lacks a clear and explicit price level or price guidance in relation to the cord blood banking services which we provide. We cannot rule out the possibility that PRC government may establish price guidance or introduce other specific price control standards for the cord blood banking services in the future. Additionally, we cannot guarantee that our subscription services will not be included in the scope of the price control or that governmental prices will be higher than our current rates or the costs of our operation. If this happens, our subscription services may become subject to compulsory or directory guidance or other restrictions imposed by the PRC government. In particular, if subscription services become subject to price controls in China, we would be required to abide by such controls and policies and we may not be able to charge our subscribers at current rates. If the government-controlled pricing or price guidance set by the relevant department of the PRC government is lower than our current pricing or the cost of our operation, our business operation or financial condition will be materially and adversely affected.
If we lose our position as the sole provider of cord blood banking services in our existing markets, our business and prospects may be materially and adversely affected.