Core Viewpoint - The National Medical Products Administration (NMPA) has rejected 118 drug listing applications over three days, including 13 first-generic products, indicating a trend towards stricter drug approval processes [1][27]. Group 1: Drug Approval Rejections - The NMPA denied applications for several first-generic drugs, including indomethacin gel patches from Jiutian Pharmaceutical and meloxicam nano-crystal injections from Health元药业 [1][27]. - The rejection of these applications poses a risk to pharmaceutical companies that have made significant investments in these products [1][27]. Group 2: Market Impact and Competition - Jiutian Pharmaceutical, known for its core product, the Loxoprofen sodium gel patch, faced a setback with its indomethacin gel patch application, which had a market share of only 0.16% compared to Nipro Pharma's indomethacin patch, which has over 45% market share and annual sales exceeding 110 million yuan [4][10]. - Four companies have submitted applications for the indomethacin gel patch, with three already receiving clinical approval, indicating a competitive landscape [5][10]. Group 3: Other Drug Applications - Other first-generic applications, such as for bilastine oral solution and brivaracetam orally disintegrating tablets, were also rejected, reflecting the stringent review process [1][27]. - The market for amlodipine besylate, a cornerstone drug for hypertension, remains strong, with sales exceeding 3.6 billion yuan in 2024, despite the influx of generic competitors [11][14]. Group 4: Future Opportunities - The failure of Jiutian Pharmaceutical and Dongyangguang Pharmaceutical in their respective applications highlights the need for companies to focus on quality and clinical needs rather than merely following trends in drug formulation [27]. - The approval of alternative formulations, such as the dry suspension and orally disintegrating tablets, suggests that there are still opportunities for innovation in the market [20][21].