Core Viewpoint - Heng Rui Medicine has received acceptance for its drug application for Haiqubopai Ethanolamine Tablets from the National Medical Products Administration, aimed at treating chemotherapy-induced thrombocytopenia in adult patients [1][2] Group 1: Drug Approval and Clinical Trials - The National Medical Products Administration has issued an acceptance notice for the drug application of Haiqubopai Ethanolamine Tablets, which is indicated for adult patients with chemotherapy-induced thrombocytopenia [1] - The Phase III clinical trial (SHR8735-301) for Haiqubopai Ethanolamine Tablets achieved its primary endpoint in May 2025, demonstrating significant efficacy compared to the control group with good safety and tolerability [1] Group 2: Existing Approvals and Market Context - Haiqubopai Ethanolamine Tablets have previously been approved for two indications: chronic primary immune thrombocytopenia in adults with poor response to corticosteroids and immunoglobulins, and severe aplastic anemia in adults with poor response to immunosuppressive therapy [2] - The drug is an oral non-peptide thrombopoietin receptor (TPO-R) agonist that promotes platelet production through the activation of TPO-R mediated STAT and MAPK signaling pathways [2] - Similar products available in the international market include Eltrombopag, Avatrombopag, and Lusutrombopag, with a combined global sales forecast of approximately $2.59 billion for 2024 [2] - The cumulative R&D investment for Haiqubopai Ethanolamine Tablets has reached approximately 445.87 million yuan [2]

Core Viewpoint - Heng Rui Medicine has received the acceptance notice from the National Medical Products Administration for its drug application of Haequbopag Ethanolamine Tablets, aimed at treating adults and children aged 6 and above with persistent and chronic primary immune thrombocytopenia (ITP) who have had inadequate responses to previous treatments [1][2] Company Summary - Haequbopag Ethanolamine Tablets are an oral non-peptide thrombopoietin receptor (TPO-R) agonist that promotes platelet production by activating the TPO-R mediated STAT and MAPK signaling pathways [2] - The company has invested approximately 44.587 million yuan in the research and development of Haequbopag Ethanolamine Tablets to date [2] Industry Summary - Similar products already available in the international market include Eltrombopag (GlaxoSmithKline/Novo Nordisk, brand name Promacta), Avatrombopag (Dova Pharmaceuticals, brand name Doptelet), and Lusutrombopag (Shionogi, brand name Mulpleta) [2] - The total global sales of these similar products are projected to be approximately 2.59 billion USD in 2024 [2] - In China, Eltrombopag was approved in 2017 under the name Aequbopag Ethanolamine Tablets, Avatrombopag was approved in 2020 as Maleic Acid Avatrombopag Tablets, and Lusutrombopag was approved in 2023 as Lusutrombopag Tablets [2]

Core Insights - The balance between innovation and generics is crucial for the healthy development of the pharmaceutical industry. Recently, the first generic drugs have become a focus for domestic pharmaceutical companies, with over 170 first generics approved from 2022 to 2023, and the number of approvals increasing year by year. In 2024, despite fierce competition from ten rounds of centralized procurement, 896 drugs have passed or are deemed to have passed consistency evaluations, with 254 being first approvals and 107 being significant first generics. Qilu Pharmaceutical topped the annual list with 7 first generics [1][2][4]. Industry Overview - The domestic generic drug market has become increasingly competitive due to market opening and reform of drug approval systems. The tenth round of national centralized procurement has intensified competition, leading to extreme pricing situations, with some injectable drugs priced lower than bottled water. This has put significant pressure on B-class enterprises, with some industry insiders claiming that generic drug projects are becoming unsustainable [2][4]. Company Performance - Leading companies in the domestic generic drug sector, such as Qilu Pharmaceutical, Kelun Pharmaceutical, and Heng Rui Medicine, have maintained strong competitive positions. In 2022, Heng Rui and Kelun each achieved 7 first generics, while in 2023, Kelun led with 6 first generics. In 2024, Qilu Pharmaceutical excelled with 7 first generics, solidifying its leading position in the generic drug field [4][5][6]. Market Dynamics - In 2024, a total of 896 generic drugs passed or were deemed to have passed consistency evaluations, with 254 being first approvals, accounting for 28.34%. The competition for first generics remains fierce, with Qilu Pharmaceutical achieving the highest number of first generics [2][4][5]. Emerging Competitors - Other companies, such as Zhengda Tianqing, also demonstrated strong R&D capabilities, achieving 5 first generics in both 2023 and 2024, maintaining a solid position in the market. Companies like Shanghai Xuantai and Wuhu Daorun have made significant gains, with Xuantai achieving 4 first generics in 2024, marking a notable improvement from 2023 [5][9][12]. Future Outlook - The generic drug market in China is expected to continue evolving, with a focus on high-quality first generics and innovative drugs. The success of first generics is concentrated in high-tech niche areas, highlighting the progress made by pharmaceutical companies in overcoming technical challenges. The competitive landscape will likely shift further as policies and market conditions change [14].