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2022年，中国出现自建国以来第一次人口负增长，自然增长率为-0.60‰。中国的总和生育率跌破1.1，全球倒数，少子化趋势的加速到来，让鼓励生育的议题走到聚光灯之下。在鼓励生育领域，率先破局的是北京市医保局。近日，北京市医保局发布通知，自2023年7月1日起，包括促排卵检查、采卵、人工授精、胚胎移植术等16项治疗性辅助生殖技术项目将纳入北京市基本医保，并按医保甲类纳入门诊报销。这意味着，沉默已久的辅助生殖终于敲开了医保的大门。图1 北京市医保局通知图片来源：北京市医保局官网辅助生殖，会是政策的新风口吗？2021年5月，“三孩政策”一声惊雷，迅速火爆全网。2021年7月，中共中央和国务院印发《关于优化生育政策促进人口长期均衡发展的决定》，鼓励生育提高到新的国家战略高度。2022年8月，国家卫健委等17部门印发《关于进一步完善和落实积极生育支持措施的指导意见》，提出逐步将适宜的分娩镇痛和辅助生殖技术项目按程序纳入基金支付范围。直至最近，北京市医保局“先行先试”，在众说纷纭中率先落子布局。这一步“先手棋”，可以说在政策层面实现了生育的松绑、对辅助生殖从市场、审批到支付的全覆盖：一方面，生育意愿的确持续下降；另一方面，辅助生殖赛道的市场规模在政策的拉动下，在稳定增长。据沙利文预测，我国辅助生殖的市场规模在2020年达到了434.1亿元，并将以每年14.5%的复合增速增长，预计2025年将达到854亿元。预计在2027年前后，就有望突破千亿市场大关。图2 中国辅助生育市场规模预测数据来源：沙利文政策的热度也逐步传导到一级市场，近5年辅助生殖投融资事件数热度不减。据动脉橙不完全统计，从“三孩政策”发布至今，共有近30家辅助生殖初创期企业完成融资，融资总额超过百亿元。红杉、IDG、丹麓、毅达、启迪之星、达晨财智等顶级机构均有加码。图3 我国辅助生殖行业投融资情况数据来源：动脉橙注册受理号243个，辅助生殖药物研发盘点在辅助生殖的整个过程中，无论采取人工授精、配子移植还试管婴儿技术，均需要对应的药物进行有效地支持。常用的辅助生殖类药物主要分为四类：降调节药物、促排卵药物、诱发排卵药物和黄体支持药物。降调节药物包括GnRH激动剂和GnRH拮抗剂；促排卵药物包括促卵泡激素、尿促性素、促黄体激素、氯米芬、来曲唑；诱发排卵包括绒促性素；黄体支持包括地屈孕酮、黄体酮等。据药智数据，我国涉及辅助生殖的药品注册受理号共有243个，其中化药74个，生物制品169个（详见文末附表1）。申请类型涉及新药、进口、仿制、补充申请等，其中补充申请最多，有153个，即大部分是旧产品的再开发或者一致性评价。仿制的大品种包括重组促卵泡素β注射液、注射用醋酸西曲瑞克、重组人促卵泡激素注射液、重组人绒促性素注射液、注射用尿促卵泡激素等。从一致性评价过评数量分析，独家过评的企业数有18家，2-3个的有83家，超过10家企业过评的有74家，大品种的竞争异常激烈。参与该赛道布局的企业包括丽珠集团、长春高新旗下的金赛药业、翰宇药业、齐鲁制药等。图4 我国涉及辅助生殖的药品注册受理申请类型分析数据来源：药智数据此外，近5年来，暂未有创新药实现进口上市，批准进口上市的品种基本在2017年之前获批，包括百慕大先灵葆雅的醋酸加尼瑞克注射液、雪兰诺欧洲公司的重组人绒促性素注射液和重组人促卵泡激素注射液、欧加农有限公司的重组促卵泡素β注射液等。这一些原研药物基本是国外巨头垄断的局面，特别是默克公司，是全球辅助生殖类药物的龙头。从目前申请注册的情况进一步分析，批准临床的共有27个批文，目前暂未有品种纳入特殊审批、优先审评和突破性治疗，反映出重大创新产品数量暂未实现突破，这一赛道的可能性尚需进一步打开。图5 我国涉及辅助生殖的药品注册审评结论数据来源：药智数据未来发展展望近年来，我国人口出生率持续下降，未来能否扭转出生人口下降的趋势，关键在于生育率是否可得到提升。在政策、资本、临床需求、技术的多重叠加下，造就了辅助生育市场巨大的发展潜力。目前国内辅助生殖的市场主要以进口产品为主，国产替代的空间巨大。特别是重组人促卵泡激素、重组促卵泡素β、重组人绒促性素等药物的市占率将有望进一步扩张。未来企业布局的策略可以关注：1、不孕不育的一个重要原因是卵巢早衰，发病率高且当前尚无防治手段，有望产生创新疗法；2、目前大多数的激素类产品半衰期短，注射频次多，患者依从性差，因此临床应用便捷的长效重组促卵泡激素是未来研发重要方向之一。3、目前不少尿源产品的蛋白杂质多，未来更高纯度的产品将有望爆发出新的潜力。4、目前产品多以注射剂为主，在给药方式创新优化方面发展出经由口服或皮肤外用仍能达到刺激排卵效果的药物，也有望成为未来的另一个发展方向。千亿赛道风云起，谁能笑傲群雄？让我们拭目以待。附表1 我国辅助生殖的药品注册与受理（部分，后台回复【辅助生殖药物】可获取全部EXCEL数据 ）数据来源：药智数据PS：药智网公众号【ID:yaozh008】后台回复【辅助生殖药物】，即可获取本文完整版EXCEL格式文档声明：本内容为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 八角转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信） 阅读原文，是受欢迎的文章哦

MELVILLE, N.Y.--( BUSINESS WIRE )--Henry Schein, Inc. (Nasdaq: HSIC), the world’s largest provider of health care products and services to office-based dental and medical practitioners, announced today the acquisition of Regional Health Care Group Pty Ltd (RHCG), a medical products distribution company serving public- and private-sector customers in Australia and New Zealand. Since 1998, Henry Schein has served the Australian and New Zealand dental market, providing a wide range of dental products, equipment, and services to dental professionals. The addition of RHCG expands Henry Schein’s offering to medical practitioners in the region. Henry Schein acquired RHCG, which had sales for the 12 months ended June 30, 2022, of $42 million, from Maurie and Bernard Stang, who wholly owned the company and retain a minority interest in Henry Schein’s ANZ dental business. Henry Schein expects the transaction to be neutral to 2023 diluted earnings per share when excluding amortization expenses and accretive thereafter. Financial terms were not disclosed. “We are pleased to welcome the Regional Health Care Group to Henry Schein,” said Stanley M. Bergman, Chairman of the Board and Chief Executive Officer of Henry Schein. “Together, we will advance our long-standing goal of helping health care professionals operate more efficient practices by providing new solutions and technologies for the ultimate benefit of patients.” Headquartered in Sydney, Australia, with an office in Auckland, New Zealand, RHCG offers a wide range of consumables, equipment, and pharmaceuticals – including many on an exclusive or semi-exclusive basis – primarily to public- and private-sector customers. The day-to-day operations of RHCG are led by General Manager Stephen Doorey, who will continue to manage the business under the highly regarded Regional Health Care Group brand. Mr. Doorey will report to Mike Covey, Vice President and Managing Director of Henry Schein’s business in Australia and New Zealand. “We are very pleased to integrate RHCG with Henry Schein, a company that shares our commitment to excellent service and provides customers with the solutions they need to deliver quality care to their patients,” said Maurie Stang. “It’s extremely gratifying to see the exciting opportunities to accelerate our growth.” About Henry Schein, Inc. Henry Schein, Inc. (Nasdaq: HSIC) is a solutions company for health care professionals powered by a network of people and technology. With more than 22,000 Team Schein Members worldwide, the Company's network of trusted advisors provides more than 1 million customers globally with more than 300 valued solutions that help improve operational success and clinical outcomes. Our Business, Clinical, Technology, and Supply Chain solutions help office-based dental and medical practitioners work more efficiently so they can provide quality care more effectively. These solutions also support dental laboratories , government and institutional health care clinics , as well as other alternate care sites. Henry Schein operates through a centralized and automated distribution network, with a selection of more than 300,000 branded products and Henry Schein private-brand products in stock. A FORTUNE 500 Company and a member of the S&P 500® index, Henry Schein is headquartered in Melville, N.Y., and has operations or affiliates in 32 countries and territories. The Company's sales reached $12.6 billion in 2022, and have grown at a compound annual rate of approximately 12.1 percent since Henry Schein became a public company in 1995. For more information, visit Henry Schein at www.henryschein.com , Facebook.com/HenrySchein , Instagram.com/HenrySchein , and Twitter.com/HenrySchein . Cautionary Note Regarding Forward-Looking Statements In accordance with the “Safe Harbor” provisions of the Private Securities Litigation Reform Act of 1995, we provide the following cautionary remarks regarding important factors that, among others, could cause future results to differ materially from the forward-looking statements, expectations and assumptions expressed or implied herein. All forward-looking statements made by us are subject to risks and uncertainties and are not guarantees of future performance. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance and achievements or industry results to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. These statements include EPS guidance and are generally identified by the use of such terms as “may,” “could,” “expect,” “intend,” “believe,” “plan,” “estimate,” “forecast,” “project,” “anticipate,” “to be,” “to make” or other comparable terms. A fuller discussion of our operations, financial condition and status of litigation matters, including factors that may affect our business and future prospects, is contained in documents we have filed with the United States Securities and Exchange Commission, or SEC, including our Annual Report on Form 10-K, and will be contained in all subsequent periodic filings we make with the SEC. These documents identify in detail important risk factors that could cause our actual performance to differ materially from current expectations. Forward looking statements include the overall impact of the Novel Coronavirus Disease 2019 (COVID-19) on the Company, its results of operations, liquidity and financial condition (including any estimates of the impact on these items), the rate and consistency with which dental and other practices resume or maintain normal operations in the United States and internationally, expectations regarding personal protective equipment (“PPE”) and COVID-19 related product sales and inventory levels, whether additional resurgences or variants of the virus will adversely impact the resumption of normal operations, whether supply chain disruptions will adversely impact our business, the impact of integration and restructuring programs as well as of any future acquisitions, general economic conditions including exchange rates, inflation and recession, and more generally current expectations regarding performance in current and future periods. Forward looking statements also include the (i) ability of the Company to have continued access to a variety of COVID-19 test types, expectations regarding COVID-19 test sales, demand and inventory levels, as well as the efficacy or relative efficacy of the test results given that the test efficacy has not been, or will not have been, independently verified under normal FDA procedures, and (ii) potential for the Company to distribute the COVID-19 vaccines and ancillary supplies. Risk factors and uncertainties that could cause actual results to differ materially from current and historical results include, but are not limited to: risks associated with COVID-19 and any variants thereof, as well as other disease outbreaks, epidemics, pandemics, or similar wide-spread public health concerns and other natural disasters; our dependence on third parties for the manufacture and supply of our products; our ability to develop or acquire and maintain and protect new products (particularly technology products) and technologies that achieve market acceptance with acceptable margins; transitional challenges associated with acquisitions, dispositions and joint ventures, including the failure to achieve anticipated synergies/benefits; financial and tax risks associated with acquisitions, dispositions and joint ventures; certain provisions in our governing documents that may discourage third-party acquisitions of us; effects of a highly competitive (including, without limitation, competition from third-party online commerce sites) and consolidating market; the repeal or judicial prohibition on implementation of the Affordable Care Act; changes in the health care industry; risks from expansion of customer purchasing power and multi-tiered costing structures; increases in shipping costs for our products or other service issues with our third-party shippers; general global and domestic macroeconomic and political conditions, including inflation, deflation, recession, fluctuations in energy pricing and the value of the U.S. dollar as compared to foreign currencies and changes to other economic indicators, international trade agreements, potential trade barriers and terrorism; failure to comply with existing and future regulatory requirements; risks associated with the EU Medical Device Regulation; failure to comply with laws and regulations relating to health care fraud or other laws and regulations; failure to comply with laws and regulations relating to the collection, storage and processing of sensitive personal information or standards in electronic health records or transmissions; changes in tax legislation; risks related to product liability, intellectual property and other claims; litigation risks; new or unanticipated litigation developments and the status of litigation matters; risks associated with customs policies or legislative import restrictions; cyberattacks or other privacy or data security breaches; risks associated with our global operations; our dependence on our senior management, employee hiring and retention, and our relationships with customers, suppliers and manufacturers; and disruptions in financial markets. The order in which these factors appear should not be construed to indicate their relative importance or priority. We caution that these factors may not be exhaustive and that many of these factors are beyond our ability to control or predict. Accordingly, any forward-looking statements contained herein should not be relied upon as a prediction of actual results. We undertake no duty and have no obligation to update forward-looking statements except as required by law.