乙磺酸尼达尼布是多重酪氨酸激酶抑制剂，能够延缓特发性肺纤维化(IPF)进程，目前上市的剂型为口 服软胶囊。与口服制剂相比，该产品具有显著提高肺部暴露量、明显改善肺功能、降低系统暴露量、显 著降低胃肠道副作用等优势。临床前研究显示，该产品在口服剂量1/200的用量下可达到同等药效，且 具有良好的安全性和有效性。 石药集团(01093)午前涨超4%，截至发稿，涨3.89%，报8.81港元，成交额5.95亿港元。 消息面上，1月2日，石药集团发布公告，集团开发的乙磺酸尼达尼布吸入粉雾剂已获中国国家药品监督 管理局批准，可在中国开展临床试验。该产品为首个在国内获批临床用于治疗肺纤维化的吸入制剂。 ...

本文源自：金融界AI电报 石药集团(01093.HK)在港公告，本集团开发的乙磺酸尼达尼布吸入粉雾剂已获中国国家药品监督管理局 批准，可在中国开展临床试验。该产品为首个在国内获批临床用于治疗肺纤维化的吸入制剂。乙磺酸尼 达尼布是多重酪氨酸激酶抑制剂，能够延缓特发性肺纤维化(IPF)进程，目前上市的剂型为口服软胶 囊。 ...

石药集团(01093)发布公告，集团开发的乙磺酸尼达尼布吸入粉雾剂已获中国国家药品监督管理局批 准，可在中国开展临床试验。 该产品为首个在国内获批临床用于治疗肺纤维化的吸入制剂。乙磺酸尼达尼布是多重酪氨酸激酶抑制 剂，能够延缓特发性肺纤维化(IPF)进程，目前上市的剂型为口服软胶囊。与口服制剂相比，该产品具 有显著提高肺部暴露量、明显改善肺功能、降低系统暴露量、显著降低胃肠道副作用等优势。临床前研 究显示，该产品在口服剂量1/200的用量下可达到同等药效，且具有良好的安全性和有效性。 本次获批的临床适应症为特发性肺纤维化。此外，该产品亦具有用于治疗系统性硬化病相关间质性肺疾 病(SSc-ILD)及进展性肺纤维化(PPF)的潜力。该产品是集团吸入技术平台的重要成果，其临床试验获批 为管线内后续吸入制剂的开发奠定了良好基础。 ...

该产品为首个在国内获批临床用于治疗肺纤维化的吸入制剂。乙磺酸尼达尼布是多重酪氨酸激酶抑制 剂，能够延缓特发性肺纤维化(IPF)进程，目前上市的剂型为口服软胶囊。与口服制剂相比，该产品具 有显著提高肺部暴露量、明显改善肺功能、降低系统暴露量、显著降低胃肠道副作用等优势。临床前研 究显示，该产品在口服剂量1/200的用量下可达到同等药效，且具有良好的安全性和有效性。 本次获批的临床适应症为特发性肺纤维化。此外，该产品亦具有用于治疗系统性硬化病相关间质性肺疾 病(SSc-ILD)及进展性肺纤维化(PPF)的潜力。该产品是集团吸入技术平台的重要成果，其临床试验获批 为管线内后续吸入制剂的开发奠定了良好基础。 智通财经APP讯，石药集团(01093)发布公告，集团开发的乙磺酸尼达尼布吸入粉雾剂已获中国国家药品 监督管理局批准，可在中国开展临床试验。 ...

本次获批的临床适应症为特发性肺纤维化。此外，该产品亦具有用于治疗系统性硬化病相关间质性肺疾 病(SSc-ILD)及进展性肺纤维化(PPF)的潜力。该产品是集团吸入技术平台的重要成果，其临床试验获批 为管线内後续吸入制剂的开发奠定了良好基础。 格隆汇1月2日丨石药集团(01093.HK)宣布，集团开发的乙磺酸尼达尼布吸入粉雾剂已获中华人民共和国 国家药品监督管理局批准，可在中国开展临床试验。 该产品为首个在国内获批临床用于治疗肺纤维化的吸入制剂。乙磺酸尼达尼布是多重酪氨酸激酶抑制 剂，能够延缓特发性肺纤维化(IPF)进程，目前上市的剂型为口服软胶囊。与口服制剂相比，该产品具 有显着提高肺部暴露量、明显改善肺功能、降低系统暴露量、显着降低胃肠道副作用等优势。临床前研 究显示，该产品在口服剂量1/200的用量下可达到同等药效，且具有良好的安全性和有效性。 ...

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 - The research indicates that lithium carbonate can induce necroptosis in myofibroblasts, significantly reversing established pulmonary fibrosis in mouse models, offering new hope for millions of patients globally [3][4]. Group 1: Research Findings - Pulmonary fibrosis is characterized by the destruction of alveolar structures and collagen deposition, leading to irreversible lung function decline and high mortality risk [2]. - Current approved drugs, pirfenidone and nintedanib, can only slow disease progression but cannot reverse fibrosis [2]. - The study utilized a mouse model of irreversible pulmonary fibrosis induced by bleomycin and silica particles, demonstrating that lithium carbonate treatment resulted in significant structural improvements in the lungs [4]. Group 2: Mechanism of Action - Lithium carbonate promotes the release of low levels of TNF-α from alveolar macrophages, which sends potential death signals to myofibroblasts [5]. - Lithium ions inhibit the activation of pro-caspase-8 in myofibroblasts, leading to the activation of the necroptosis pathway and overcoming the anti-apoptotic barrier of these cells [5]. Group 3: Implications for Treatment - The research suggests that while existing drugs merely slow down fibrosis progression, lithium carbonate effectively removes the driving force behind fibrosis by targeting myofibroblasts [7]. - This study not only provides new treatment hope for pulmonary fibrosis patients but also offers theoretical support for interventions in other organ fibrosis diseases, such as liver, kidney, and heart fibrosis [7].

Core Insights - The article discusses the development of a novel treatment strategy for pulmonary fibrosis called "exosome nebulization therapy," which has been researched by a collaborative team from Tsinghua University and other institutions [1][5][7] Group 1: Health Issues Related to Pulmonary Fibrosis - Pulmonary fibrosis is characterized by the gradual scarring of lung tissue, leading to severe breathing difficulties and is often referred to as "the cancer that does not die" due to its chronic and progressive nature [2][3] - The disease can be classified into two main types: idiopathic pulmonary fibrosis, which has an unknown cause and poor prognosis, and secondary pulmonary fibrosis, which has identifiable triggers such as infections or autoimmune diseases [2][3] Group 2: Current Treatment Limitations - Current treatments for pulmonary fibrosis, such as pirfenidone and nintedanib, can only stabilize the condition and delay progression but cannot reverse fibrosis or improve survival rates [5][7] - Lung transplantation remains the only curative option, but its application is limited by donor shortages and postoperative complications [5][7] Group 3: Exosome Nebulization Therapy - Exosome nebulization therapy utilizes exosomes derived from human umbilical cord mesenchymal stem cells, which contain various proteins and RNAs that play crucial roles in cellular communication and immune response [5][6] - The therapy involves nebulizing these exosomes into fine particles for inhalation, allowing for targeted delivery to lung lesions, enhancing treatment precision compared to traditional stem cell therapies [6][7] - Animal studies have shown that this therapy significantly improves pulmonary fibrosis progression, with survival rates in treated mice increasing from 20% to 80% [6][7] Group 4: Clinical Trials and Future Directions - Initial clinical trials involving 24 patients demonstrated good safety and significant improvements in lung function and respiratory health for those receiving combined treatment with exosome nebulization and standard medication [7][8] - Despite the promising results, further large-scale Phase II and III clinical trials are necessary to fully validate the efficacy of exosome therapy [8] - Regulatory challenges exist in approving exosome therapy as a commercial drug due to its complex composition, necessitating the development of a more flexible evaluation system for its application [8]