siRNA疗法
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靖因药业IPO:32项重大专利未获授权 靠非经常损益扭亏只是昙花一现 ?
Xin Lang Zheng Quan· 2025-11-14 05:38
Core Viewpoint - Sirius Therapeutics has submitted its listing application to the Hong Kong Stock Exchange, with a valuation of approximately $253 million after its Series B funding round in April 2025, backed by prominent investors [1][2]. Group 1: Company Overview - Sirius Therapeutics was established in 2021 and focuses on developing siRNA therapies [1]. - The company is co-founded by top healthcare investment firms OrbiMed Entities and Creacion Ventures, holding over 40% of shares, with Tencent's investment arm holding 8.14% and Hancan Capital holding over 13% [1]. - The company reported a net loss of 309 million yuan and 342 million yuan for 2023 and 2024, respectively, totaling 651 million yuan in losses [3]. Group 2: Financial Performance - In the first half of 2025, Sirius Therapeutics achieved a net profit of 34.46 million yuan, marking its first profitable period, primarily driven by non-recurring income [3][4]. - The company generated 144 million yuan in other income, a significant increase from 4.51 million yuan in the same period last year, largely due to a strategic partnership with CRISPR Therapeutics [3][4]. Group 3: Product Pipeline and Challenges - The core product, SRSD107, is in Phase II clinical trials for venous thromboembolism, while two key products, SRSD216 and SRSD384, are also in various stages of development [5][6]. - The company faces significant competition in the FXI/FXIa inhibitor space, with several competitors already in Phase III trials, including drugs from Novartis, Bayer, and Johnson & Johnson [7][8]. - Sirius Therapeutics has 65 patents and applications, but only one has been granted, with 32 critical patents pending, posing potential risks in a competitive biopharmaceutical landscape [9].
靖因药业冲击IPO,聚焦小核酸创新药领域,尚未有产品获批
Ge Long Hui· 2025-11-05 09:24
Group 1: Industry Overview - The small RNA drug sector has gained significant attention in recent years, with Alnylam (ALNY) seeing a stock price increase of over 60 times since its IPO, reaching a market capitalization of $55.9 billion [1] - Major pharmaceutical companies like Novartis and Roche are increasing their investments in this field [1] - Several domestic companies in China, including Yuyuan Pharmaceutical, Hengrui Medicine, and others, are also developing small RNA drugs [1] Group 2: Company Profile - Sirius Therapeutics - Sirius Therapeutics, founded in 2021, is a global clinical-stage biotechnology company focused on siRNA therapies for chronic diseases, with a dual headquarters in San Diego and Shanghai [3][8] - The company has completed three rounds of financing, raising approximately $144 million, with major investors including OrbiMed Entities and Creacion Ventures [3] - As of April 2025, the company's post-investment valuation is approximately $253 million [4] Group 3: Product Pipeline - The core product, SRSD107, is a siRNA drug targeting coagulation factor XI, currently in Phase II clinical trials in Europe, with plans for additional trials in China and Australia/New Zealand [16][19] - SRSD216, another key product, targets Lp(a) to lower its levels, addressing a significant unmet need in cardiovascular disease management [22][23] - SRSD384 is a candidate drug targeting obesity, currently advancing towards IND application [17] Group 4: Financial Performance - Sirius Therapeutics has not generated any revenue from product sales, with other income primarily from bank interest and investment returns [24] - The company reported losses of approximately 616 million yuan over two and a half years, mainly due to R&D expenditures [25] - As of June 2025, the company had cash and cash equivalents of 618 million yuan, estimated to sustain operations for 30 months [27] Group 5: Market Potential - The global siRNA therapy market is projected to reach $2.4 billion in 2024, with an expected growth to $50.3 billion by 2040, reflecting a compound annual growth rate of 20.9% [13] - Since the approval of the first siRNA drug, Onpattro, in 2018, significant clinical and commercial validation has been achieved, with seven siRNA products currently approved in major markets [12]
靖因药业 筹划港股上市
Zhong Guo Zheng Quan Bao· 2025-10-17 14:50
Core Insights - Jingyin Pharmaceutical has appointed Guozheng International Securities (Hong Kong) Limited as its overall coordinator for its IPO application submitted to the Hong Kong Stock Exchange on September 28, 2023 [1] - The company is a global clinical-stage biotechnology firm focused on the clinical and commercial value of siRNA therapies, with no candidate drugs commercialized to date [1][4] - The company reported net losses of 309 million yuan and 342 million yuan for 2023 and 2024, respectively, but achieved a net profit of 34.46 million yuan in the first half of 2025 [1][4] Company Overview - Jingyin Pharmaceutical was co-founded by OrbiMed Entities and Creacion Ventures in 2021, with dual headquarters in San Diego and Shanghai [2] - The company has completed multiple rounds of financing since its inception, including Series A, B, and B2 rounds [2] Key Products and Development - The core product, SRSD107, is a potential first-in-class siRNA drug targeting coagulation factor XI, currently undergoing Phase II clinical trials in Europe, with plans for additional trials in China and Australia/New Zealand [2] - Other products include SRSD216, targeting Lp(a), and SRSD384, aimed at obesity, with ongoing clinical trials [2] Collaborations and Financials - In May 2025, Jingyin Pharmaceutical entered a collaboration agreement with CRISPR Therapeutics for SRSD107, receiving an upfront payment of $95 million and potential milestone payments exceeding $800 million [3] - The company has 65 patents and patent applications, including 14 related to its core products [3] Financial Performance - The company reported significant net losses since its establishment, with R&D expenses of 233 million yuan, 213 million yuan, and 64.67 million yuan for 2023, 2024, and the first half of 2025, respectively [4] - Operating cash outflows were 209 million yuan and 180 million yuan for 2023 and 2024, with a net cash inflow of 97.95 million yuan in the first half of 2025 [5] Future Funding Needs - Jingyin Pharmaceutical may require substantial additional funding through public offerings, private equity, debt financing, or partnerships to sustain operations [6]
靖因药业,筹划港股上市
Zhong Guo Zheng Quan Bao· 2025-10-17 12:15
Core Insights - Jingyin Pharmaceutical has appointed Guozheng International Securities (Hong Kong) Limited as its overall coordinator for its upcoming IPO, having submitted its listing application to the Hong Kong Stock Exchange on September 28 [1] - The company is a global clinical-stage biotechnology firm focused on realizing the clinical and commercial value of siRNA therapies, with no candidate drugs yet commercialized [1][4] - The company reported net losses of 309 million yuan and 342 million yuan for 2023 and 2024, respectively, but achieved a net profit of 34.46 million yuan in the first half of 2025, indicating a turnaround [1][4] Product Development - The core product, SRSD107, is currently undergoing a Phase II clinical trial in Europe, with plans to initiate another Phase II trial in China and Australia/New Zealand [2] - SRSD216, another key product, is in a Phase IIa trial in both China and the U.S., targeting Lp(a) [2] - SRSD384, aimed at obesity, is actively progressing towards IND application [2] Strategic Partnerships - In May 2025, Jingyin Pharmaceutical entered into a collaboration agreement with CRISPR Therapeutics for the development and commercialization of SRSD107, receiving an upfront payment of $95 million and potential milestone payments exceeding $800 million [3] - The partnership involves a 50-50 cost and profit-sharing mechanism for the development of SRSD107 [3] Financial Overview - The company has incurred significant net losses since its inception, with R&D expenses of 233 million yuan, 213 million yuan, and 64.67 million yuan for 2023, 2024, and the first half of 2025, respectively [4] - Other income surged from 4.5 million yuan in the first half of 2024 to 144 million yuan in the first half of 2025, primarily due to the fair value gains from financial assets related to the CRISPR collaboration [4] Cash Flow and Funding Needs - Operating cash outflows were 209 million yuan and 180 million yuan for 2023 and 2024, respectively, while the first half of 2025 saw a net cash inflow of 97.95 million yuan [5] - The company may require substantial additional funding through public offerings, private equity, debt financing, or partnerships to sustain operations [6]
靖因药业估值18亿冲刺港股IPO:上半年扭亏为盈,腾讯参股
Sou Hu Cai Jing· 2025-09-29 10:23
Core Viewpoint - Sirius Therapeutics-B (靖因药业) has submitted its listing application to the Hong Kong Stock Exchange, focusing on the clinical and commercial potential of siRNA therapies, with three main product pipelines targeting coagulation disorders, cardiovascular metabolic diseases, and obesity [3]. Group 1: Company Overview - Sirius Therapeutics-B is a global clinical-stage biotechnology company dedicated to maximizing the clinical and commercial value of siRNA therapies [3]. - The company has developed three major product pipelines, with SRSD107 as its core product, targeting coagulation factor XI and currently undergoing Phase II clinical trials in Europe [3]. - The company has established a global collaboration with CRISPR Therapeutics for the development and commercialization of SRSD107 [3]. Group 2: Financial Performance - The company reported no revenue or sales costs during the historical performance period [4]. - For 2023 and 2024, other income and gains were RMB 8.81 million and RMB 9.79 million, respectively, while the net loss attributable to shareholders was RMB -309.09 million and RMB -342.00 million [4][6]. - In the first half of 2025, other income and gains surged to RMB 144.61 million, a year-on-year increase of 3094.81%, with a net profit of RMB 34.46 million, marking a turnaround from losses [4][6]. Group 3: Funding and Valuation - Since its inception, the company has completed three rounds of financing, raising a total of approximately USD 144 million, with the latest round valuing the company at USD 25.3 million (approximately RMB 1.8 billion) [7]. - Major shareholders include OrbiMed Entities and Creacion Ventures, each holding approximately 20.23% of the company's issued share capital [10].
靖因药业递表港交所 高盛、海通国际、HSBC为联席保荐人
Zheng Quan Shi Bao Wang· 2025-09-29 00:45
Core Viewpoint - Jingyin Pharmaceutical is a global clinical-stage biotechnology company focused on developing siRNA therapies and has submitted a listing application to the Hong Kong Stock Exchange, with Goldman Sachs, Haitong International, and HSBC as joint sponsors [1] Industry Summary - The siRNA therapy market is projected to grow from $2.4 billion in 2024 to $50.3 billion by 2040, representing a compound annual growth rate (CAGR) of 20.9% [1] - siRNA therapies address disease mechanisms at the nucleic acid level and can target "undruggable" proteins that traditional technologies struggle to reach, offering a paradigm shift in chronic disease management with advantages such as longer durability, higher compliance, good safety profile, and lower drug interactions [1] Company Summary - The company has three core product pipelines focusing on coagulation disorders, cardiovascular metabolic diseases, and obesity [1] - SRSD107 is a potential first-in-class siRNA drug targeting coagulation factor XI, currently undergoing Phase II clinical trials in Europe [1] - SRSD216 is a potential best-in-class siRNA targeting Lp(a), with ongoing Phase IIa trials in China and the United States [1] - SRSD384 is an INHBE-targeting candidate drug for obesity, supported by compelling preclinical data, and is actively pursuing IND application [1] - The company’s proprietary PEPR platform includes chemical modifications, target and sequence optimization, and delivery technologies, and is researching extrahepatic delivery systems to expand the range of siRNA effects [1]
靖因药业递表港交所 以siRNA疗法赋能慢性病管理范式转变
Zhi Tong Cai Jing· 2025-09-28 23:22
Core Viewpoint - Jingyin Pharmaceutical has submitted its listing application to the Hong Kong Stock Exchange, with Goldman Sachs, Haitong International, and HSBC acting as joint sponsors [1] Company Overview - Jingyin Pharmaceutical is a global clinical-stage biotechnology company focused on maximizing the clinical and commercial value of siRNA therapies. The company aims to innovate treatment standards for chronic diseases through its proprietary siRNA technology platform and global collaboration network [4][5] - The siRNA therapy market is projected to reach USD 2.4 billion in 2024 and grow to USD 50.3 billion by 2040, with a compound annual growth rate (CAGR) of 20.9% [4] Product Pipeline - The company is advancing three major product pipelines targeting coagulation disorders, cardiovascular metabolic diseases, and obesity, each with significant market potential. In 2024, these therapeutic areas are expected to have at least one blockbuster drug with annual sales exceeding USD 10 billion [5] - Key pipeline products include: - SRSD107: A potential first-in-class siRNA drug targeting coagulation factor XI, currently in Phase II clinical trials in Europe and planned for trials in China and Australia/New Zealand - SRSD216: A potential best-in-class siRNA targeting Lp(a), undergoing Phase IIa trials in China and the U.S. - SRSD384: An INHBE-targeting candidate for obesity, with promising preclinical data and active IND application [5] Financial Performance - For the six months ending June 30, 2023, 2024, and 2025, the company reported other income and revenue of approximately RMB 8.81 million, RMB 9.79 million, and RMB 14.4 million, respectively. The net loss for the same periods was approximately RMB 309 million, RMB 342 million, and RMB 34.5 million [6][7] - Administrative expenses and R&D expenses for the same periods were RMB 25.56 million, RMB 22.71 million, and RMB 233.42 million, RMB 213.33 million, respectively [7]
靖因药业向港交所递交上市申请 加速潜在重磅疗法的全球临床开发
Ge Long Hui· 2025-09-28 14:37
Core Viewpoint - Jingyin Pharmaceuticals has submitted a listing application to the Hong Kong Stock Exchange, aiming to accelerate the global clinical development of its potential blockbuster therapies [1] Group 1: Company Overview - Jingyin Pharmaceuticals is a global clinical-stage biotechnology company focused on maximizing the clinical and commercial value of siRNA therapies [1] - The company is built on three major potential blockbuster product pipelines, a proprietary siRNA technology platform, and a global collaboration network [1] Group 2: Product Pipeline - The company is advancing three major product pipelines targeting coagulation disorders, cardiovascular metabolic diseases, and obesity, which are based on their significant market potential and the ability to provide transformative siRNA solutions [2] - Each of these therapeutic areas is expected to have at least one blockbuster drug with annual global sales exceeding $10 billion by 2024, along with multiple other drugs generating annual sales in the billions [2] - Key pipeline products include: - SRSD107, a potential first-in-class siRNA drug targeting coagulation factor XI, currently undergoing Phase II multi-center clinical trials in Europe, with plans for additional trials in China and Australia/New Zealand [2] - SRSD216, a potential best-in-class siRNA targeting Lp(a), currently in Phase IIa trials in both China and the U.S. [2] - SRSD384, an INHBE-targeting candidate for obesity, which is advancing towards IND submission [2] Group 3: Leadership and Intellectual Property - The company is led by a cross-Pacific team that combines global strategic vision and deep expertise in siRNA technology, capable of advancing drug candidates from discovery to commercialization [3] - Founded in 2021 by OrbiMed Entities and Creacion Ventures, the company has dual headquarters in San Diego and Shanghai, leveraging complementary advantages from both U.S. and Chinese biotech ecosystems [3] - As of the latest feasible date, the company holds or co-holds 65 patents and patent applications, including 14 related to its core products [3] Group 4: Financials and Use of Proceeds - The company has not generated any revenue or sales costs during the reporting period [3] - For the first half of 2024 and the year ending June 30, 2025, the main R&D expenses for SRSD107 were RMB 48.8 million and RMB 19.8 million, accounting for 33.6% and 70.0% of total technical service expenses, respectively [3] - The net proceeds from the financing will be used for: - R&D of core product SRSD107, which is expected to enter Phase III trials by 2026 [4] - R&D of key product SRSD216 [4] - R&D of key product SRSD384, which is rapidly advancing towards IND-supported research and subsequent clinical trials [4] - Development of pipeline projects including extrahepatic projects [4] - Working capital and business development to enhance financial flexibility and maintain daily operations while strategically increasing the global potential of its pipeline [4]
瑞博生物转战港交所:18年“烧钱”未果 “技术换现金”能否撑起35亿估值?
Xin Lang Zheng Quan· 2025-05-21 01:20
Core Viewpoint - Suzhou Rebio Biotechnology Co., Ltd. is attempting to re-enter the capital market by submitting a prospectus to the Hong Kong Stock Exchange after failing to launch on the STAR Market four years ago, despite being one of the earliest companies in China to focus on small RNA drugs [1][3] Group 1: Company Overview - Founded in 2007, Rebio focuses on developing innovative therapies for cardiovascular, metabolic, renal, and liver diseases, particularly siRNA therapies [1] - The company has six self-developed drug pipelines currently in clinical trials, with four in Phase II and one in Phase III [1] Group 2: R&D Progress and Challenges - The fastest progressing pipeline, RBD1007, completed international Phase II/III research data analysis in 2021 but has not yet resulted in a marketable product [3] - Previous key pipelines RBD4988 and RBD1006 are not mentioned in the latest prospectus, indicating they may have "failed" [3] - The new core pipelines include RBD4059 for thrombotic diseases, RBD5044 for hypertriglyceridemia, and RBD1016 for chronic hepatitis B and D, all currently in Phase II, facing significant uncertainty regarding clinical efficacy and market viability [3][4] Group 3: Market Competition - Rebio's R&D progress is lagging behind competitors, with its core product RBD4059 in Phase II while similar products from Novartis have reached Phase III [4] - Ionis's APOC3-targeted drug has already been launched, raising doubts about Rebio's "Best-in-Class" potential for RBD5044, which has yet to release clinical data [4] Group 4: Financial Performance and Valuation - Rebio's valuation has fluctuated significantly, from 456 million yuan in 2015 to 3.15 billion yuan in 2020, peaking at 4.87 billion yuan in 2024, but has since dropped back to 3.58 billion yuan, equivalent to its valuation five years ago [5][6] - In 2023, the company reported revenue of only 44,000 yuan, which is expected to rise to 143 million yuan in 2024 through a partnership with Boehringer Ingelheim, but 90% of this revenue relies on a single partner, indicating a fragile income structure [6] - Total R&D expenses for 2023 and 2024 are projected to be 590 million yuan, with cumulative net losses reaching 718 million yuan, and cash reserves expected to be only 168 million yuan by the end of 2024, against interest-bearing loans of 399 million yuan, putting significant pressure on the company's cash flow [6] Group 5: Strategic Partnerships and Risks - Rebio has frequently utilized licensing agreements to alleviate financial pressure, including a deal with Boehringer Ingelheim worth over $2 billion and a licensing agreement for RBD7022 in Greater China for over 700 million yuan [7] - While these partnerships provide short-term cash flow, they may compromise future value, as the agreements do not clearly define patent ownership improvements, potentially limiting Rebio's share in future developments based on its core delivery technology [7]
Sarepta Therapeutics(SRPT) - 2025 Q1 - Earnings Call Transcript
2025-05-06 20:30
Financial Data and Key Metrics Changes - In Q1 2025, the company achieved total net product revenue of $612 million, representing a 70% growth year-over-year [6][38] - Elevitus sales reached $375 million, marking a 180% increase compared to the same quarter last year [6][38] - The PMO franchise generated $237 million, up 5% year-over-year [6][38] - The company revised its net product revenue guidance for 2025 to a range of $2.3 billion to $2.6 billion, reflecting a 37% increase from 2024 at the midpoint [7][42] Business Line Data and Key Metrics Changes - The PMO franchise grew by 5%, while Elevitus saw a significant increase of 180% in sales [6][38] - Collaboration and other revenues amounted to $133 million, primarily from Roche [38] Market Data and Key Metrics Changes - The company noted that 60% of current revenue comes from top sites, which are experiencing high demand and long wait times for appointments [12] - The administrative process for gene therapy has become more complex, leading to longer turnaround times for infusions [10][18] Company Strategy and Development Direction - The company is focusing on addressing administrative challenges and enhancing site capacity to improve patient access to Elevitus [19] - A comprehensive promotional campaign for Elevitus was launched to increase awareness and understanding among healthcare providers and patients [20] - The company aims to expand its treatment network by engaging more community sites to alleviate capacity issues at top centers [19] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges faced in Q1 2025, including a severe flu season and a tragic safety event that impacted patient infusions [5][16] - The company remains optimistic about long-term demand for Elevitus, expecting a recovery in sales starting in the summer [17][64] - Management emphasized the importance of education and communication to address concerns stemming from the recent safety event [52][60] Other Important Information - The company reported a GAAP net loss of $448 million for Q1 2025, primarily due to increased R&D expenses related to a collaboration with Arrowhead [41] - The company has a strong cash position with $647 million in cash and equivalents, plus an additional $600 million available through a revolving credit facility [36][42] Q&A Session Summary Question: What has been the biggest driver of potential downside pressure leading to revised guidance? - Management indicated that it is a mix of all three factors: cycle times, administrative processes, and the safety event, with cycle times being the most mechanically impactful [47][48] Question: How does the company direct patients to sites with more capacity? - Management clarified that it is more about focus and education rather than the number of sites, emphasizing the need to engage secondary sites more effectively [57][58] Question: What percentage of sales does Elevitus represent in the new guidance? - Management confirmed that the revision in total net product revenue was exclusively related to Elevitus, which is the primary driver of the guidance change [66] Question: What are the expectations regarding the potential label update for Elevitus? - Management stated that a labeling supplement was submitted in April, with a target review date set for no later than Q4 2025 [76]