<p>（第一财经）4 月 16 日——中国将优化新上市药品的初始定价机制，允许制药公司根据临床重要性以及高水平创新药物开发中涉及的高投资和风险来设定价格。</p>
<p>根据国务院办公厅发布的新政策文件，制药公司将根据临床价值、市场供需、竞争格局和社会承受能力等多种因素独立确定新药的初始价格。</p>
<p>对于具有强创新性和临床重要性的创新药物，中国政府支持企业设定与高研发投资和风险相一致的上市价格，并在一定时期内维持该价格。未来的调整可能基于实际临床效果进行。</p>
<p>新政策澄清了关于独立药品定价的模糊性，清华大学医院管理研究所教授兼研究员陈怡告诉第一财经。尽管大多数新药在纳入国家医疗保险目录之前采用公司主导的定价，但之前的定价依据不明确且不一致，而新政策明确将其建立在临床价值的基础上，并与高研发成本和风险相匹配，陈怡指出。</p>
<p>“高投资、高风险” 这一说法实质上意味着监管机构允许创新药企在定价的经济评估中考虑研发成本和失败风险，上海健康发展研究中心主任金春林对第一财经表示。此外，企业在评估临床重要性时必须优先考虑患者利益，金春林补充道。</p>
<p>允许创新药物 “在上市后维持相对稳定的价格一段时间” 的规定反映了对原研药在专利期内的制度保护，金春林指出。</p>
<p>新机制标志着中国在向市场主导的定价机制进一步转变，为创新药物创造了更有利的政策环境，金春林表示。</p>
<p>编辑：唐诗华，马丁·卡迪耶夫</p>

天弘国证生物医药ETF

易方达中证创新药产业ETF

华夏上证科创板生物医药ETF

<p>中国正在优化新上市药品的定价机制，允许制药公司根据临床重要性和研发成本来设定价格。新政策支持企业在考虑市场需求和竞争的基础上确定初始价格，同时确保患者利益优先。它澄清了药品定价中的先前模糊之处，并允许在上市后的一段时间内保持稳定价格，反映出对创新药物市场主导定价机制的转变</p>

<p>(Yicai) April 16 -- China will optimize the initial pricing mechanism for newly launched medicines, allowing pharmaceutical companies to set prices based on clinical significance and the high investment and risk involved in the development of high-level innovative drugs.</p>
<div class="lb-trans"><p>（第一财经）4 月 16 日——中国将优化新上市药品的初始定价机制，允许制药公司根据临床重要性以及高水平创新药物开发中涉及的高投资和风险来设定价格。</p>
</div><p>Drugmakers will independently determine new medicines' initial prices by considering various factors, including clinical value, market supply and demand, competition landscape, and social affordability, according to a new policy document issued by the General Office of the State Council.</p>
<div class="lb-trans"><p>根据国务院办公厅发布的新政策文件，制药公司将根据临床价值、市场供需、竞争格局和社会承受能力等多种因素独立确定新药的初始价格。</p>
</div><p>For innovative drugs with strong innovation and clinical significance, the Chinese government supports firms in setting launch prices aligned with high research and development investment and risks, as well as maintaining them for a certain period. Future adjustments may be made based on actual clinical effectiveness.</p>
<div class="lb-trans"><p>对于具有强创新性和临床重要性的创新药物，中国政府支持企业设定与高研发投资和风险相一致的上市价格，并在一定时期内维持该价格。未来的调整可能基于实际临床效果进行。</p>
</div><p>The new policy clarifies ambiguities surrounding independent drug pricing, Chen Yi, professor and researcher at Tsinghua University's Institute of Hospital Management, told Yicai. Although most new medicines adopt company-led pricing before inclusion in the national medical insurance catalog, the pricing basis was previously unclear and inconsistent, but the new policy has explicitly set it on clinical value, matched with high R&amp;D costs and risks, Chen noted.</p>
<div class="lb-trans"><p>新政策澄清了关于独立药品定价的模糊性，清华大学医院管理研究所教授兼研究员陈怡告诉第一财经。尽管大多数新药在纳入国家医疗保险目录之前采用公司主导的定价，但之前的定价依据不明确且不一致，而新政策明确将其建立在临床价值的基础上，并与高研发成本和风险相匹配，陈怡指出。</p>
</div><p>The phrase &#34;high investment, high risk&#34; essentially means regulators allow innovative drugmakers to factor R&amp;D costs and failure risks into economic evaluations for pricing, Jin Chunlin, director of the Shanghai Health Development Research Center, said to Yicai. In addition, firms must prioritize patient benefits when assessing clinical significance, Jin added.</p>
<div class="lb-trans"><p>“高投资、高风险” 这一说法实质上意味着监管机构允许创新药企在定价的经济评估中考虑研发成本和失败风险，上海健康发展研究中心主任金春林对第一财经表示。此外，企业在评估临床重要性时必须优先考虑患者利益，金春林补充道。</p>
</div><p>The stipulation allowing innovative drugs to &#34;maintain relatively stable prices for a certain period after launch&#34; reflects institutional protection for originator drugs during patent terms, Jin pointed out.</p>
<div class="lb-trans"><p>允许创新药物 “在上市后维持相对稳定的价格一段时间” 的规定反映了对原研药在专利期内的制度保护，金春林指出。</p>
</div><p>The new mechanism marks a further shift toward a market-led pricing mechanism in China, creating a more favorable policy environment for innovative drugs, according to Jin.</p>
<div class="lb-trans"><p>新机制标志着中国在向市场主导的定价机制进一步转变，为创新药物创造了更有利的政策环境，金春林表示。</p>
</div><p>Editors: Tang Shihua, Martin Kadiev</p>
<div class="lb-trans"><p>编辑：唐诗华，马丁·卡迪耶夫</p>
</div>

China to Let Firms Set New Drug Prices Based on Clinical Value, R&D Costs and Risks

Yicai

华夏医药ETF

创新药

国泰中证生物医药ETF

平安中证医疗创新ETF

鹏华上证科创板生物医药ETF

招商中证生物科技主题ETF

华夏恒生生物科技ETF(QDII)

创新药ETF工银

华宝恒生港股通创新药精选ETF

易方达沪深300医药ETF

华夏中证生物科技主题ETF

博时恒生港股通创新药精选ETF

中国将允许企业根据临床价值、研发成本和风险来设定新药的价格