交银国际:内地药品法修订利委托生产 料药明生物受惠 但加剧研发竞争
交银国际发表报告表示,本周一(26日)内地新修订的《药品管理法》表决通过,其中包括第一是将临床试验管理由批准制改为默认许可制;第二是建立药品上市许可持有人制度(MAH):拥有药品技术的研发机构和生产企业均可通过提出申请获得药品注册证书,并对该药的全生命周期承担责任。法案明确,药品上市许可持有人可委托药品生产企业生产。
该行表示,目前国内药品上市许可通常只颁发给有生产许可的药企,而委托生产面临多重监管限制,MAH 制度的优势在於可以让不具备生产能力的研发机构通过成为持有人及委托生产的方式,将科研成果转化为市场化产品,以激励行业创新。
交银国际称,新制度的实施将利好於外包生产企业,如药明生物(02269.HK)(予「买入」评级及目标价100元),但由於加剧了研发竞争,对传统药企的研发能力提出更高的要求。该行继续偏好自主研发能力突出、在研管线丰富的公司,首推买入石药(01093.HK)(予「买入」评级及目标价19.5元)。
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