Core Viewpoint - Betta Pharmaceuticals has announced that several of its products have been included in the National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug List for 2025, which is expected to enhance the accessibility and market potential of these drugs [1] Group 1 - Betta Pharmaceuticals' products included in the 2025 drug list are: - Hydrochloride Alectinib Tablets (Kaimena) - Hydrochloride Ensartinib Capsules (Beimana) - Mesylate Bafetinib Capsules (Saimena) - Voronib Tablets (Fumeina) [1] - Additionally, the company's Bevacizumab Injection (Beanding) has been included in the National Medical Insurance Category B drug list [1]

Core Viewpoint - Beida Pharmaceutical reported a decline in net profit for the first half of the year, attributing the drop to increased depreciation and amortization expenses, alongside rising sales, management, and financial costs, while R&D investment decreased by over 20% [1][3][5]. Financial Performance - The company achieved a revenue of 1.731 billion yuan, a year-on-year increase of 15.37%, but net profit fell to 140 million yuan, a decrease of 37.53% [3][4]. - This marks the first instance of a year-on-year decline in net profit since 2022 [3]. - EBITDA reached 497.81 million yuan, reflecting a growth of 13.1% [4]. R&D Investment - R&D expenditure for the first half of the year was 299 million yuan, down 21.8% year-on-year [6]. - The decline in R&D investment raises concerns about the company's future product pipeline and technological advantages [7]. Cost Structure - Sales expenses increased to approximately 594 million yuan, a rise of 13.34% [6]. - Management expenses were reported at 261 million yuan, up 23.47%, while financial expenses surged by 118.06% to 39.53 million yuan [6]. Debt Obligations - Beida Pharmaceutical has an overdue milestone payment of 180 million yuan to Yifang Biotechnology, which has not been settled [8][9]. - The payment is related to the approval of specific cancer treatment indications and has been delayed due to the company's financial arrangements [8][9].

Core Viewpoint - Beida Pharmaceutical reported a decline in net profit for the first half of the year, attributing the drop to increased depreciation and amortization expenses, alongside rising sales, management, and financial costs [1][6][9] Financial Performance - The company achieved a revenue of 1.731 billion yuan, representing a year-on-year growth of 15.37%, while net profit fell to 140 million yuan, a decrease of 37.53% [6][7] - The EBITDA reached approximately 497.81 million yuan, showing a growth of 13.1% [7] R&D Investment - R&D investment decreased by over 20% year-on-year, totaling 299 million yuan, with a similar decline projected for the next year [8][9] - The reduction in R&D spending raises concerns about the company's future product pipeline and competitive edge [10] Expense Trends - Sales expenses increased to approximately 594 million yuan, up 13.34% year-on-year, while management and financial expenses also rose significantly [9] - Management expenses were reported at 261 million yuan, a 23.47% increase, and financial expenses reached 39.53 million yuan, up 118.06% [9] Debt Obligations - The company has an overdue milestone payment of 180 million yuan to Yifang Biotechnology, which has raised concerns about its financial health and potential impact on future collaborations [11][12][14] - The overdue payment reflects internal financial management issues and could harm the company's reputation and future business opportunities [14]

Core Viewpoint - The approval of Enasidenib capsules (brand name: Beimingna) by the Macao Drug Regulatory Authority marks a significant milestone for the company in treating ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) patients [1] Group 1: Product Development and Approvals - Enasidenib is a new generation ALK inhibitor developed jointly by the company and its subsidiary Xcovery [1] - The drug received approval for second-line indications from the National Medical Products Administration of China in November 2020 [1] - In March 2022, the first-line indication was approved, followed by the approval for clinical trials of postoperative adjuvant therapy in April 2022, with ongoing Phase III clinical research [1] Group 2: Market Access and Insurance Inclusion - Enasidenib was included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2023) with an agreement valid until December 31, 2025 [1] - The first-line indication is expected to receive approval from the U.S. Food and Drug Administration in December 2024 [1] Group 3: Competitive Landscape - As of the announcement date, other ALK inhibitors available in Macao include Crizotinib, Ceritinib, Alectinib, Brigatinib, and Lorlatinib [1]

Core Viewpoint - The company has submitted a drug registration application for Ensartinib capsules to the Macau Drug Administration, aiming to treat patients with locally advanced or metastatic non-small cell lung cancer who are positive for anaplastic lymphoma kinase (ALK) [1] Group 1 - The drug, marketed as Baimena, is a new generation ALK inhibitor developed in collaboration with the company's subsidiary, Xcovery [1] - Ensartinib has already received marketing approval in China and the United States, and the company is advancing the application process in Europe [1] - The company will continue to monitor the review progress, and the short-term impact of this application on the company's operating performance is not expected to be significant [1]