根据《中华人民共和国药品管理法》及有关规定，经审查，2025年7月10日受理的LXH-1211片临床试验 申请符合药品注册的有关要求，同意本品开展肺动脉高压的临床试验。 山东新华制药（000756）股份(00719)发布公告，近日，公司收到国家药品监督管理局核准签发的LXH- 1211片《药物临床试验批准通知书》。 LXH-1211片是针对肺动脉高压的临床表现和疾病病理本质设计的结构全新的化合物。研究显示LXH- 1211具有双重作用机制，既能通过刺激可溶性鸟苷酸环化酶(sGC)产生血管舒张效应，降低肺动脉高 压，也能通过抑制AMP-激活蛋白激酶(AMPK)阻止血管重构和纤维化进程。本品拟定的临床适应症为 治疗肺动脉高压。 ...

Core Insights - The announcement from Yuan Da Pharmaceutical regarding the new specification (20ml: 50mg) of its drug, Qufei Lianer injection, received approval from the National Medical Products Administration on September 22, indicating a significant development in the treatment of pulmonary arterial hypertension (PAH) [1] - Qufei Lianer injection is the only drug in China that can be administered subcutaneously and intravenously for PAH treatment, which is a first-line medication and a foundational drug in targeted therapy regimens [1][5] - The PAH market is projected to grow significantly, with an estimated global market size of approximately $8.06 billion in 2024, expected to reach around $13.5 billion by 2034, reflecting a compound annual growth rate (CAGR) of 5.3% [5] Company Insights - Qufei Lianer is a synthetic prostacyclin analog that promotes vasodilation and inhibits platelet aggregation, effectively treating PAH symptoms [5] - The drug has demonstrated long-term efficacy and safety in clinical studies, with one-year and four-year survival rates of 88% and 70%, respectively, indicating a significant improvement in patient prognosis [5] - The sales revenue of Qufei Lianer has consistently exceeded $100 million annually, achieving approximately $517 million in global sales in 2020 [5][6] - In China, the sales growth of Qufei Lianer injection was remarkable, with a year-on-year increase of 186.89% in 2021 [6] Industry Insights - PAH is a rare cardiovascular disease with a high mortality rate, historically referred to as "the cancer of the cardiopulmonary system," with a median survival of only 2.8 years before the advent of targeted therapies [2] - The prevalence of PAH has nearly doubled globally from 1990 to 2021, with an incidence rate of approximately 2.4 per million person-years and a prevalence rate of about 15 per million [1][2] - The five-year survival rate for PAH patients has improved from 34% in 1991 to nearly 57% in recent years, with an average survival time of 6.2 years [2]

曲前列尼尔是一种人工合成的前列环素类似物，可以促进血管舒张，同时抑制血小板聚集，进而治疗 PAH的症状。多项临床研究已经证实曲前列尼尔长期应用的有效性和安全性，单药治疗1年和4年的生存 率分别是88%和70%，患者预后得到显着改善。曲前列尼尔注射液已是临床上治疗PAH的一线用药以及 靶向药物联合治疗方案中的基础用药，且是国内唯一可用于治疗PAH的皮下和静脉给药前列环素类药 物。集团曲前列尼尔注射液的获批上市，成功改变了该产品国内市场单品垄断的市场格局，有望进一步 降低PAH患者的医疗负担。 格隆汇9月23日丨远大医药(00512.HK)公告，集团用于治疗肺动脉高压(pulmonary arterial hypertension， 「PAH」，WHO分类1)的产品曲前列尼尔注射液的新规格(20ml:50mg)，近日获得中华人民共和国国家 药品监督管理局颁发药品注册证书，产品20ml:20mg的规格已于2023年3月获批上市。产品为医保目录 产品，两种规格将有助临床医生根据患者的情况提供更加精准的治疗方案，这是集团在心脑血管急救领 域罕见病方向的重大进展。 ...

Group 1: Product Development and Regulatory Approvals - The company has received a drug registration certificate from the National Medical Products Administration of China for a new specification (20ml:50mg) of its product, Treprostinil injection, used for treating pulmonary arterial hypertension (PAH) [1] - The existing specification (20ml:20mg) was approved for market launch in March 2023, and both specifications are included in the medical insurance catalog, allowing for more precise treatment options for clinicians [1] - The company has reached an equity investment and product cooperation agreement with Shanghai Zhongqiang Pharmaceutical Co., Ltd., which includes acquiring approximately 14.42% equity and exclusive commercialization rights for Treprostinil inhalation formulation in Greater China [2] Group 2: Market Potential and Epidemiology - PAH is a rare cardiovascular disease with an incidence rate of approximately 2.4 per million person-years and a prevalence of about 15 per million, leading to high mortality and disability rates [3] - The global PAH market is projected to reach approximately $8.06 billion in 2024, with a compound annual growth rate (CAGR) of 5.3%, and the Asia-Pacific region expected to grow at a CAGR of 13.3% [3] Group 3: Clinical Efficacy and Treatment Landscape - Treprostinil is a synthetic prostacyclin analog that promotes vasodilation and inhibits platelet aggregation, with clinical studies showing significant long-term efficacy and safety [4] - The one-year and four-year survival rates for patients on Treprostinil monotherapy are 88% and 70%, respectively, indicating a substantial improvement in patient prognosis [4] - The approval of Treprostinil injection has altered the market landscape by reducing the monopoly of single products in the domestic market, potentially lowering the medical burden on PAH patients [4] Group 4: Commitment to Rare Diseases and Innovation - The company is focused on developing treatments for rare diseases, with over 20 products in the pipeline, including those for conditions like N-acetylglutamate synthase deficiency and hyperammonemia [5] - The company aims to address the clinical needs in the rare disease sector, responding to government and societal calls, and is committed to increasing the development of effective treatments for rare diseases [5] - The company emphasizes innovation and advanced technology in product development, aiming to create a global sales network and enhance its international presence [6][7]

Core Viewpoint - The company has made significant progress in the treatment of pulmonary arterial hypertension (PAH) with the approval of a new specification for its drug, which will enhance treatment options for patients [1][4]. Group 1: Product Development and Approval - The company received a drug registration certificate from the National Medical Products Administration for a new specification (20ml: 50mg) of its drug for PAH treatment, complementing the previously approved 20ml: 20mg specification [1]. - The new specifications will allow clinicians to provide more precise treatment plans based on patient needs, marking a major advancement in the rare disease sector of cardiovascular emergency care [1]. - The company has also entered into an equity investment and product cooperation agreement with Shanghai Zhongqiang Pharmaceutical, acquiring approximately 14.42% equity and exclusive commercialization rights for various formulations of its PAH treatment [2]. Group 2: Market Potential and Epidemiology - PAH is a rare cardiovascular disease with an incidence rate of approximately 2.4 per million person-years and a prevalence of about 15 per million, indicating a significant unmet medical need [3]. - The global PAH market is projected to reach approximately $8.06 billion in 2024, with a compound annual growth rate (CAGR) of 5.3%, and the Asia-Pacific region expected to grow at a CAGR of 13.3% [3]. Group 3: Clinical Efficacy and Treatment Landscape - The drug, a synthetic prostacyclin analog, has demonstrated long-term efficacy and safety in clinical studies, with survival rates of 88% and 70% at one and four years, respectively [4]. - The approval of the injection solution has altered the market dynamics, potentially reducing the financial burden on PAH patients [4]. Group 4: Commitment to Rare Diseases - The company is focused on developing treatments for rare diseases, with over 20 products in the pipeline, including those for conditions like N-acetylglutamate synthase deficiency and Cushing's disease [5]. - The company aims to address the significant challenges faced by rare disease patients, where only 5% of such diseases have effective treatments available [5]. Group 5: Innovation and Global Strategy - The company emphasizes innovation and advanced technology in product development, aiming to meet unmet clinical needs and enhance its product pipeline [6][7]. - A strategy of global operational layout and dual-circulation development is being adopted to promote domestic and international growth [6][7].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對 其準確性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內 容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 Grand Pharmaceutical Group Limited 遠大醫藥集團有限公司* ( 於百慕達註冊成立之有限公司 ) (股份代號: 00512) 自願性公告 曲前列尼爾注射液（20ml : 50mg）獲頒發藥品註冊證書 本公告乃遠大醫藥集團有限公司（「本公司」，連同其附屬公司統稱「本集團」）之 董事會（「董事會」）自願刊發。 董事會欣然公告，本集團用於治療肺動脈高壓（pulmonary arterial hypertension， 「PAH」，WHO 分類 1）的產品曲前列尼爾注射液的新規格（20ml : 50mg），近日獲 得中華人民共和國國家藥品監督管理局（中國藥監局）頒發藥品註冊證書，本產品 20ml:20mg 的規格已於二零二三年三月獲批上市。本產品爲醫保目錄產品，兩種規格 將有助於臨床醫生根據患者的情況提供更加精准的治療方案，這是本集團在心腦血管 急救領域罕見病方向的重大進展。 本集 ...

Summary of Tenax Therapeutics (TENX) Conference Call Company Overview - Tenax Therapeutics is focused on the Phase III development of an oral formulation of a drug for group two pulmonary hypertension (PH) patients with an ejection fraction greater than 40% [4][5] - The drug has been approved in 60 countries and has a history of 25 years for a different indication [4] Industry Context - Pulmonary hypertension (PH) is characterized by elevated pulmonary pressure in the lungs and is categorized into five subgroups, with group two associated with left heart disease [6] - Approximately 50% of heart failure patients develop pulmonary hypertension, with a significant portion being HFpEF (Heart Failure with preserved Ejection Fraction) [6] Market Opportunity - The American heart failure population was about 6.7 million in 2020, projected to rise to 8.5 million by 2030 [7] - More than half of new diagnoses in March are patients with an ejection fraction greater than 40% [8] - The addressable market for the drug is estimated at $10 billion, given that 50-80% of HFpEF patients may have pulmonary hypertension [8] Drug Development Insights - The company is leveraging legacy data and previous studies to support the development of their drug, which aims to lower wedge pressure without significantly affecting pulmonary artery pressure [24] - The Phase II HELP trial demonstrated a significant reduction in pulmonary wedge pressure during exercise, indicating the drug's potential efficacy [17][31] Clinical Trials - The ongoing Phase III trial (Level) is enrolling 230 subjects, with a primary endpoint of the six-minute walk test [36] - A second Phase III trial (Level 2) is planned to start this year, with a larger patient population and a longer duration [37][48] - The company is focused on careful site selection for trials to ensure effective enrollment and data collection [49][51] Safety and Efficacy - No new safety signals have been observed in the ongoing trials, and the drug has shown to be well-tolerated [40] - The drug's hemodynamic effects are well understood, and it has a favorable safety profile compared to surgical alternatives [30][31] Financial Outlook - The company is funded through 2027, with key value drivers including patient enrollment milestones and the potential to address a significant unmet medical need in the pulmonary hypertension market [58] Conclusion - Tenax Therapeutics is positioned to address a critical gap in the treatment of pulmonary hypertension, with a strong focus on clinical development and leveraging existing data to support its drug's efficacy and safety [58]

Financial Data and Key Metrics Changes - The company recorded $6 million in net sales of Eutrebia in Q2 2025, with a strong start in Q3 2025 [41] - The initial uptake of Eutrebia exceeded expectations, with over 900 prescriptions and more than 550 patient starts in the first eleven weeks post-launch [4][3] Business Line Data and Key Metrics Changes - Eutrebia's early uptake is attributed to its unique delivery, device, and dosing capabilities, which are expected to differentiate it in the market [5][6] - The company aims to penetrate the underdeveloped PHILD market, which has significant growth potential due to its current underutilization [15] Market Data and Key Metrics Changes - The addressable market for PAH is estimated to be around $3 billion, with potential for significant growth as the company identifies more patients [21] - The company believes that the PHILD opportunity could reach $30 to $45 billion, indicating a substantial market potential [25] Company Strategy and Development Direction - The company is focused on expanding its market presence through disease education and patient identification, particularly in the PHILD market [15] - The strategy includes leveraging the unique dosing capabilities of Eutrebia to capture market share from existing treatments [6][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving profitability within three to four quarters post-launch, supported by a strong cash position of over $170 million [70] - The company is optimistic about the continued growth trajectory of Eutrebia, with sustained momentum observed since the launch [40] Other Important Information - The company has signed contracts with three national payers in the commercial space to ensure patient access and minimize reimbursement barriers [32] - The ongoing legal proceedings related to the three two seven FAT and TRY are expected to conclude by October, with management prepared for various outcomes [46][49] Q&A Session Summary Question: How confident is the company about the initial uptake of Eutrebia? - Management believes the early uptake is indicative of sustained growth, as feedback from physicians shows a demand for Eutrebia among various patient types [9] Question: What is the potential market size for Eutrebia? - The company estimates the addressable market for PAH could be as high as $3 billion, with significant room for growth in both PAH and PHILD markets [21][25] Question: How is the company addressing payer access and reimbursement? - The company has successfully signed contracts with national payers and achieved a 75% fill rate in the first six weeks of launch, aiming to improve this further [33][34] Question: What is the company's strategy for future product development? - The company plans to focus on the upcoming L606 product, leveraging its expertise in pulmonary hypertension to address unmet needs in the market [62][57]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $3.1 million, an increase from $3.0 million in Q1 2024, primarily due to the promotion agreement despite lower sales volumes [12] - Research and development expenses decreased by 31% to $7.0 million from $10.1 million year-over-year, mainly due to a reduction in personnel expenses as the focus shifted towards commercialization preparations [13] - General and administrative expenses increased by 48% to $30.1 million from $20.2 million, driven by higher personnel costs and legal fees related to ongoing litigation [14] - The net loss for Q1 2025 was $38.4 million, or $0.45 per share, compared to a net loss of $30.1 million, or $0.40 per share, in Q1 2024 [14] Business Line Data and Key Metrics Changes - The company is preparing for the potential launch of Eutrebia, an inhaled dry powder formulation for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PHILD) [6][7] - Cohort A of the ASCENT study is fully enrolled with over 50 patients, showing positive trends in dosing and tolerability [8] Market Data and Key Metrics Changes - The company anticipates a significant market opportunity in the inhaled treprostinil market, estimated at $2 billion, with additional opportunities in the oral prostacyclines market [65] - The expected payer mix for the prostacyclin market includes approximately 50% Medicare, 35% commercial, 10% Medicaid, and 5% other [71] Company Strategy and Development Direction - The company is focused on five strategic areas for the launch of Eutrebia: developing a best-in-class product profile, ensuring robust product availability, preparing a full suite of patient support services, establishing strong payer access, and maintaining a competitive share of voice in the market [7][10][11] - The company aims to transition patients from existing therapies to Eutrebia, emphasizing its differentiated product profile and ease of use [9][33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming launch of Eutrebia, highlighting the favorable court ruling against United Therapeutics as a positive development [6][7] - The management team is optimistic about the potential for Eutrebia to become the first-choice treatment for patients with PAH and PHILD [16] Other Important Information - The company is preparing for data presentations at the American Thoracic Society's International Conference, showcasing interim results from the ASCENT study [8][51] - The company is also working on a global study for L606, a liposomal sustained release formulation of treprostinil, expected to initiate by the end of the year [29] Q&A Session Summary Question: Does United Therapeutics have any injunctive value left on the dismissed cross claim? - Management clarified that there are currently no active proceedings from United Therapeutics seeking to block FDA approval for Eutrebia, and the dismissal was without prejudice, meaning they could attempt to refile [20][22] Question: What are the patient baseline characteristics for the upcoming transition studies? - The transition study will focus on patients with PHILD currently on Tyvaso, evaluating safety and efficacy during the transition to Eutrebia [26][27] Question: What is the level of awareness of Eutrebia among targeted physicians? - Awareness is expected to increase significantly post-launch, with a comprehensive marketing strategy in place to ensure that healthcare providers are informed about Eutrebia's benefits [60][61] Question: What is the anticipated payer mix for PAH and PILD? - The expected payer mix includes approximately 50% Medicare, 35% commercial, 10% Medicaid, and 5% other [71] Question: Can you provide details on the four ninety-four patent infringement suit? - Management refrained from commenting on the specifics of the lawsuit, stating it is in the early stages [72]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $3.1 million, a slight increase from $3.0 million in Q1 2024, primarily due to the promotion agreement despite lower sales volumes [11] - Research and development expenses decreased by 31% to $7.0 million from $10.1 million year-over-year, attributed to a shift in focus towards commercialization preparations for Eutrebia [12] - General and administrative expenses increased by 48% to $30.1 million from $20.2 million, driven by higher personnel costs and legal fees related to ongoing litigation [13] - The net loss for Q1 2025 was $38.4 million, or $0.45 per share, compared to a net loss of $30.1 million, or $0.40 per share, in Q1 2024 [13] Business Line Data and Key Metrics Changes - The company is focusing on the potential launch of Eutrebia, an inhaled dry powder formulation for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PHILD) [5][6] - Cohort A of the ASCENT study is fully enrolled with over 50 patients, showing positive trends in dosing and tolerability compared to previous studies [7] Market Data and Key Metrics Changes - The company anticipates a significant market opportunity in the inhaled treprostinil market, estimated at $2 billion, with additional opportunities in the oral prostacyclines market [66] - The expected payer mix for the prostacyclin market includes approximately 50% Medicare, 35% commercial, 10% Medicaid, and 5% other [73] Company Strategy and Development Direction - The company is preparing for the launch of Eutrebia by focusing on five strategic areas: product profile development, sales force readiness, patient support services, product availability, and payer access [6][10] - The company aims to position Eutrebia as a best-in-class therapeutic alternative for patients with PAH and PHILD [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming launch of Eutrebia, highlighting the favorable court ruling against United Therapeutics as a positive development [5][6] - The management team is optimistic about the differentiated product profile of Eutrebia and its potential to capture market share from existing therapies [10][66] Other Important Information - The ASCENT study data will be presented at the American Thoracic Society's International Conference, showcasing the product's tolerability and efficacy [7][56] - The company is actively preparing for potential legal challenges from competitors but remains confident in its position [22] Q&A Session Summary Question: Does United Therapeutics have any injunctive value left on the dismissed cross claim? - Management clarified that there are currently no active proceedings from United Therapeutics seeking to block Eutrebia's approval, and the dismissal was without prejudice, allowing for potential future actions [20][22] Question: What are the patient baseline characteristics for the upcoming transition studies? - The transition study will focus on patients with PHILD currently on Tyvaso, evaluating safety and efficacy during the transition to Eutrebia [26][27] Question: What is the company's strategy for converting patients to the dry powder formulation? - Management believes Eutrebia's formulation will provide a better patient experience, and they plan to target new patient starts initially before transitioning existing nebulized patients [33][36] Question: What will the prescriber support team look like? - The prescriber support team will leverage extensive experience in the field to enhance the prescribing experience and ensure patient access to Eutrebia [44][46] Question: What is the expected payer mix for PAH and PILD? - The anticipated payer mix includes about 50% Medicare, 35% commercial, and 10% Medicaid [73] Question: Can you provide details on the four ninety-four patent infringement suit? - Management refrained from commenting on the specifics of the lawsuit, stating it is in the early stages [75]