2018年，电影《我不是药神》上映，讲述了主人公代购境外"平价特效药"帮助白血病患者的故事。其原 型陆勇从印度进口未获国内审批的仿制药救助病友，最终检察机关作出不起诉决定，尽显法治温度。 时隔七年，另一则"境外抗癌药代购"案却令人愤慨：涉案人毛某打着"境外低价"噱头，炮制国产原创抗 癌专利药安罗替尼牟利，价格在1500元左右一盒。经鉴定，该仿制药完全不含有效成分。2025年6月， 法院以妨害药品管理罪判处被告人毛某有期徒刑一年。目前，涉案的仿制药已经停产。 这把法律标尺，清晰丈量出"互助"与"骗局"的本质边界，让每一份裁决都经得起情理与法理的双重检 验。 案件之外，更值得深思的是患者用药困境。近年来，我国持续推进抗癌药纳入医保，但医保覆盖的完善 需要过程。这也要求，相关部门需加快医保优化节奏，缩小报销缺口；同时，需及时进行信息公开，让 患者清晰知晓用药保障范围与合法购药途径，从根源上挤压非正规渠道生存空间。 更深层面上，保护药品知识产权同样刻不容缓。一款原创抗癌药的诞生，往往需要耗费数十年的研发周 期和巨额资金。安罗替尼斩获国家专利金奖、服务万千患者，正是创新成果受保护的生动体现。 唯有让法治兼具温度与力度， ...

Financial Data and Key Metrics Changes - Revenues in Q3 2025 were $811,000, up 22% compared to $677,000 in Q3 2024, marking the fifth consecutive quarter of double-digit growth [19][17] - Gross margin in Q3 2025 was 83.3%, down from 85.4% in Q3 2024, attributed to higher discounting and stronger unit growth in lower-margin programs [20][21] - Operating loss in Q3 2025 was $2.1 million, a 27% increase compared to a $1.7 million loss in Q3 2024 [25] Business Line Data and Key Metrics Changes - The company achieved a 22% revenue growth in Q3 2025, driven by a 38% increase in unit deliveries, primarily from the financial assistance program [19][20] - The RED device is seeing good physician interest, but its adoption is slower due to changes in practice flow and habits [14][48] Market Data and Key Metrics Changes - The company now has approximately 55 million covered lives, indicating positive payer momentum [7] - The new Category 1 CPT code, effective January 1, 2026, is expected to streamline coding and reimbursement, significantly impacting market access [10][11] Company Strategy and Development Direction - The company is focused on expanding access through medical policy coverage and accelerating utilization of IB-STIM, with a strong emphasis on pediatric coverage [5][6] - The strategy includes mobilizing a coalition for payer engagement and prioritizing children's hospitals for treatment [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the gradual improvement of policy changes and prior authorization processes, expecting continued revenue growth [6][9] - The company is preparing for a significant transition in 2026 with the new CPT code, which is anticipated to enhance revenue predictability [33][35] Other Important Information - The company raised an additional $2.8 million in October 2025 through an equity offering, improving its liquidity position [26][50] - The company is committed to treating all patients regardless of income level or insurance coverage, which is reflected in its financial assistance program [20] Q&A Session Summary Question: How is the company tracking success and incentivizing the team for expected volume inflection? - The company has a strong sales force with a commission structure that incentivizes prioritization of accounts with good insurance coverage [31][32] Question: Any updates on engagement with payers for national coverage? - Management believes payers are aware of the new CPT code and are responsive, with a comprehensive approach being taken for engagement [38][39] Question: Can you quantify additional commercial investment and its impact on SG&A growth? - Marketing expenses have more than doubled as the company targets payers specifically, with expectations for continued higher marketing costs into 2026 [40][41]

Financial Data and Key Metrics Changes - Revenues in Q3 2025 were $811,000, up 22% compared to $677,000 in Q3 2024, marking the fifth consecutive quarter of double-digit growth [20][18] - Gross margin in Q3 2025 was 83.3%, down from 85.4% in Q3 2024, attributed to higher discounting and stronger unit growth in lower-margin programs [21][22] - Operating loss in Q3 2025 was $2.1 million, a 27% increase compared to a $1.7 million loss in Q3 2024 [27] - Cash on hand as of September 30, 2025, was $4.4 million, with an additional $2.8 million raised in October 2025 [28][52] Business Line Data and Key Metrics Changes - The company achieved a 22% revenue growth driven by a 38% increase in unit deliveries, primarily from the financial assistance program [20][19] - The RED device is seeing good physician interest, but adoption is slower due to changes in practice flow and habits [15][50] Market Data and Key Metrics Changes - Approximately 55 million covered lives are now associated with the company's products, indicating positive payer momentum [8] - The new Category 1 CPT code, effective January 1, 2026, is expected to streamline coding and reimbursement, significantly impacting market access [11][12] Company Strategy and Development Direction - The company is focused on expanding access through medical policy coverage and accelerating utilization of IB-STIM, particularly in pediatric populations [4][5] - A multi-channel approach is being employed to engage payers, including support from academic societies and leading children's hospitals [6][8] - The strategy includes prioritizing children's hospitals based on utilization potential and launching comprehensive education and outreach programs [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the gradual improvement of policy changes and prior authorization processes, emphasizing the importance of insurance coverage and physician compensation for adoption [7][10] - The company anticipates continued revenue growth in the coming quarters, driven by the new CPT code and expanded market opportunities [10][19] Other Important Information - The company is preparing for a significant transition in 2026 with the new CPT code, which is expected to enhance reimbursement and reduce barriers to access [11][12] - The RED device's future revenue ramp is uncertain, pending further clarity on CPT code reimbursement [50] Q&A Session Summary Question: How is the company tracking success and incentivizing the team ahead of expected volume inflection? - The company has a strong sales force that is highly incentivized and focused on areas with good insurance policy coverage [32][33] Question: Can the company provide insights on volume inflection from the Category 1 CPT code alone? - The company has begun forecasting and expects better adoption rates in areas with insurance coverage [37] Question: Any updates on engagement with payers and national coverage? - Payers are responsive and aware of the new Category 1 code, which adds credibility to the company's position [40][41] Question: Can the company quantify additional commercial investment and its impact on SG&A growth? - Marketing expenses have more than doubled as the company targets payers, and R&D costs are expected to increase with market expansion [43][45]

Core Viewpoint - Yasheng Pharmaceutical has transformed from an undervalued entity to a highly sought-after player in the pharmaceutical sector within six months, with its stock price doubling and a significant increase in sales of its core product, Nairike, by over 90% [1] Financial Performance - In the first half of 2025, Yasheng Pharmaceutical reported total revenue of RMB 234 million, a year-on-year decline of 71.6%, primarily due to a high base from significant overseas licensing milestone payments in H1 2024 [2] - Excluding one-time revenues, Nairike's sales reached RMB 217 million, reflecting a 93% year-on-year growth, driven by the inclusion of all approved indications in the national medical insurance catalog [2] - As of June 30, 2025, the company's cash and bank deposits amounted to RMB 1.661 billion, a 31.7% increase, largely due to approximately RMB 970 million raised from its IPO in the U.S. [2] Core Product Driving Growth - Nairike, Yasheng's first commercialized product, is the first third-generation BCR-ABL inhibitor approved in China, targeting patients with TKI resistance and T315I mutations [3] - Since January 2025, all approved indications for Nairike have been included in the national medical insurance drug list, with an annual reimbursement standard of RMB 174,500, enhancing patient affordability and accessibility [3] - By June 30, 2025, Nairike's sales in China increased from RMB 113 million in the previous year to RMB 217 million, with the number of hospitals carrying the product rising by 47% [3] Dual-Engine Commercialization Strategy - On July 10, 2025, Yasheng's second core product, Lishengtuo, was approved for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma [4] - Lishengtuo is the first domestically approved original Bcl-2 inhibitor in China and the second globally, indicating significant market potential [4] Rapid Commercialization of Lishengtuo - Following its approval, Yasheng quickly signed cooperation agreements with major pharmaceutical distribution companies to advance its commercialization efforts [5] - Within 15 days, the product was prescribed in over 40 hospitals across more than 30 cities, demonstrating swift market entry [6] Global R&D Pipeline - Yasheng is accelerating the global clinical development of its pipeline, with nine Phase III clinical studies underway, three of which have received FDA approval [7] - The Bcl-2 inhibitor APG-2575 is considered a promising candidate, targeting high-value indications such as CLL, AML, and MM [7] - Nairike has three global Phase III studies in progress, with one receiving FDA approval for use in Ph+ALL patients [7] Commercialization Strategy: From Single Product to Multi-curve Layout - Yasheng employs a hybrid model of "self-sales + cooperative licensing" to mitigate risks, optimizing its domestic coverage while sharing market and registration costs with partners abroad [9] - The company is diversifying its pipeline with IAP inhibitors and MDM2 inhibitors, aiming to reduce reliance on single products [10] - In the blood cancer sector, Yasheng aims to replicate the success of AbbVie's Venetoclax, which achieved significant sales through continuous indication expansion [11] Conclusion - The rapid growth of Nairike demonstrates a viable path for Yasheng in the commercialization of original domestic drugs, but future growth will depend on the clinical and registration pace of subsequent pipelines like APG-2575 and the effectiveness of its international expansion strategy [12]

Core Viewpoint - The article highlights the significant delay in the coverage of innovative medical devices by Medicare and Medicaid in the U.S., which can take nearly six years after FDA approval, impacting patient access to potentially life-saving technologies [1][2][5]. Group 1: FDA Approval vs. CMS Payment - The commercialization path for medical devices in the U.S. is often described as having "two doors," with the first being FDA approval for safety and efficacy, and the second being CMS payment coverage [3][10]. - The average time from FDA approval to CMS coverage decision for innovative devices requiring new payment pathways is nearly six years [2][5]. - Without CMS coverage, even advanced products remain unaffordable for most patients, limiting their market reach [4][10]. Group 2: Challenges of Innovation - U.S. companies face a dilemma where FDA approval signifies potential but CMS payment decisions are crucial for clinical adoption [5][16]. - The lack of payment pathways leads to a situation where only a few financially capable patients can access new devices, while most remain excluded [4][10]. Group 3: Current Policy Attempts and Limitations - CMS has introduced programs like TCET (Transitional Coverage for Emerging Technologies) to provide temporary payment for new technologies while collecting clinical evidence [9][14]. - The MCIT (Medicare Coverage of Innovative Technology) framework aimed to automatically cover FDA-approved products but was controversial and ultimately discontinued [9][14]. Group 4: Impact on Companies and Investors - FDA approval does not guarantee commercial success, as many companies struggle with payment obstacles post-approval, leading to extended exit timelines for venture capital [16][17]. - The uncertainty in payment pathways has accelerated mergers and acquisitions in the industry, as smaller companies seek partnerships with larger firms to navigate these challenges [18][19]. Group 5: Broader Implications - The article emphasizes that the challenges faced by U.S. companies in securing payment for innovative products reflect a global issue in healthcare innovation, where technological advancements often outpace regulatory and reimbursement frameworks [21].