Financial Data and Key Metrics Changes - The company anticipates a greater than $5 billion commercial opportunity starting at the end of the decade and escalating into the early 2030s [10] - The influenza program is expected to provide protection to approximately 110 million people in the U.S., with 85 million being high-risk or immunocompromised individuals [9] Business Line Data and Key Metrics Changes - The launch of Ohtuvayre for COPD treatment has received excellent feedback, and the company sees a significant opportunity to scale this product [17][18] - Winrevair in pulmonary arterial hypertension (PAH) is meeting high expectations, with continuous positive feedback from the medical community [28][29] Market Data and Key Metrics Changes - In the last influenza season, there were 1.6 million hospitalizations due to influenza in the U.S., highlighting the high unmet medical need [10] - The company is seeing strong uptake in the triple segment of the PAH population, with plans to penetrate further into the dual category [32] Company Strategy and Development Direction - The company is focusing on the commercialization of CD388, an antiviral treatment for influenza that is strain agnostic and effective across various populations [6][8] - The strategy includes leveraging existing commercial capabilities to enhance the launch and market penetration of new products like Ohtuvayre and Winrevair [20][21] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the significant unmet need in the influenza market and the potential for CD388 to address this issue effectively [5][6] - The company is optimistic about the future of its respiratory portfolio and the potential for new products to transform patient outcomes [19][20] Other Important Information - The company is preparing for the launch of an oral PCSK9 inhibitor, which is expected to improve access and adherence for patients needing cholesterol management [40][46] - The company is also exploring multiple indications for its TL1A mechanism, which has shown promise in inflammatory and fibrotic diseases [67][68] Q&A Session Summary Question: Insights on the Cidara deal and its growth opportunity - Management highlighted the high unmet medical need for influenza treatment and the strain-agnostic efficacy of CD388, which is expected to be a significant commercial opportunity [5][6] Question: Commercial approach for high-risk patients - The company plans to include both vaccinated and unvaccinated high-risk individuals in the phase 3 program, with payer research indicating a favorable price point for the treatment [12][13] Question: Feedback on Ohtuvayre and its market potential - The feedback from customers has been excellent, and the company believes it can significantly scale the product using its commercial engine [17][18] Question: Future steps for Winrevair in PAH - Management expressed confidence in the product's performance and noted that they are seeing positive feedback and uptake in the market [28][29] Question: Expectations for the oral PCSK9 program - The company anticipates that the oral PCSK9 will provide robust LDL lowering and improve access for patients, potentially changing treatment guidelines [40][46] Question: Update on Gardasil and vaccine portfolio - The company expects modest growth for Gardasil moving forward, with ongoing efforts to drive vaccination rates globally [54][55] Question: TL1A mechanism and future indications - Management is optimistic about the TL1A mechanism's potential across multiple indications, with several phase 2 studies planned [67][68]

Financial Data and Key Metrics Changes - United Therapeutics reported record total revenues of $800 million for Q3 2025, representing a 7% growth from Q3 2024 [8] - The company is guiding for a revenue run rate of $4 billion by 2027 [6] Business Line Data and Key Metrics Changes - Continued year-over-year growth in Tyvaso and Orenitram sales, with Tyvaso showing double-digit revenue growth [8] - The launch of Tyvaso DPI is driving a meaningful shift in treprostinil dosing behavior, with an increase in average dosing from nine breaths per treatment to twelve breaths [9] - The introduction of new Tyvaso DPI 80 microgram cartridges is expected to enhance patient convenience and dosing flexibility [10] Market Data and Key Metrics Changes - The company has secured multiple favorable coverage decisions with major payers, validating Tyvaso DPI's market position [11] - The TETON 2 study demonstrated unprecedented treatment benefits for inhaled treprostinil in patients with idiopathic pulmonary fibrosis (IPF), potentially broadening the therapeutic reach [11] Company Strategy and Development Direction - United Therapeutics is actively engaged in business development and anticipates partnerships with major pharmaceutical companies due to its strong data in pulmonary disease [6] - The company is focusing on expanding its product portfolio in pulmonary fibrosis, which presents a larger market opportunity compared to pulmonary hypertension [60] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth profile of Tyvaso, expecting continued growth in both pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [42] - The management is optimistic about the potential for ralinepag, highlighting its long patent life and synergy with other treatments [28] Other Important Information - The company is preparing for upcoming conferences to present its pipeline and engage with investors [3][4] - The Remunity Pro pump was launched to enhance the experience of parenteral therapy for patients [11] Q&A Session Summary Question: Are you seeing an uptick in diagnoses of IPF patients due to TETON 2 results? - Management noted that physicians are more aggressive in screening for pulmonary hypertension in IPF patients, but it is too early to quantify any direct impact on sales [15][17] Question: What is the market opportunity for ralinepag? - Ralinepag is exceeding expectations, with strong enrollment in its outcomes trial and best-in-class results in six-minute walk distances [26][28] Question: Can you clarify the guidance for a $4 billion run rate by 2027? - Management confirmed the expectation to reach $1 billion in quarterly revenue by 2027, driven by strong IPF results [38][40] Question: What are the commercial dynamics for Tyvaso? - Management indicated no material impact from the launch of Eutrepia, with continued strong growth in patient shipments and prescriber metrics [41][42] Question: What is the status of the TETON PPF enrollment and regulatory path? - Enrollment is about halfway through, and the company is meeting with the FDA to discuss expediting the regulatory review process [50][51] Question: What are the launch plans for the new 80 microgram cartridge for Tyvaso DPI? - The new cartridge is expected to launch within 30 to 60 days, aimed at enhancing patient convenience and dosing [58][60]

Core Viewpoint - Shandong Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the clinical trial of LXH-1211 tablets, aimed at treating pulmonary arterial hypertension [1] Company Summary - The clinical trial application for LXH-1211 tablets was accepted on July 10, 2025, and meets the requirements for drug registration [1] - LXH-1211 is a novel compound designed specifically for the clinical manifestations and pathological essence of pulmonary arterial hypertension [1] Mechanism of Action - LXH-1211 exhibits a dual mechanism of action: it stimulates soluble guanylate cyclase (sGC) to induce vasodilation and reduce pulmonary arterial hypertension, while also inhibiting AMP-activated protein kinase (AMPK) to prevent vascular remodeling and fibrosis [1] Clinical Indication - The proposed clinical indication for LXH-1211 is the treatment of pulmonary arterial hypertension [1]

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]

Core Viewpoint - The approval of a new specification for the drug Treprostinil Injection by the National Medical Products Administration of China marks a significant advancement for the company in the treatment of pulmonary arterial hypertension (PAH) [1] Group 1: Product Approval - The new specification (20ml:50mg) for Treprostinil Injection has recently received a drug registration certificate [1] - The previous specification (20ml:20mg) was approved for market launch in March 2023 [1] - Both specifications are included in the medical insurance catalog, allowing for more precise treatment options for clinicians based on patient needs [1] Group 2: Clinical Significance - Treprostinil is a synthetic prostacyclin analog that promotes vasodilation and inhibits platelet aggregation, effectively treating PAH symptoms [1] - Clinical studies have demonstrated the long-term efficacy and safety of Treprostinil, with one-year and four-year survival rates of 88% and 70%, respectively [1] - Treprostinil Injection is a first-line treatment and a foundational drug in targeted combination therapies for PAH [1] Group 3: Market Impact - The approval of Treprostinil Injection alters the market landscape by breaking the previous monopoly of a single product in the domestic market [1] - This development is expected to further reduce the medical burden on PAH patients [1]

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]