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Business Wire
08-07-2025
- Health
- Business Wire
眼科领域迎来重大突破！Hengrui的Heng Qin®（全氟己基辛烷滴眼液）获批成为首个治疗睑板腺功能障碍(MGD)相关干眼症的药物
中国江苏、德国海德堡和马萨诸塞州剑桥--(BUSINESS WIRE)--(美国商业资讯)-- 专注于科技创新的全球性制药企业Jiangsu Hengrui Pharmaceuticals Co., Ltd. ('Hengrui Pharma')与专注于研发基于独特EyeSol ® 无水技术的同类首创及最佳眼科疗法的生物制药公司Novaliq GmbH ('Novaliq')今日宣布，中国国家药品监督管理局(NMPA)已批准Heng Qin ® （全氟己基辛烷滴眼液）用于治疗与睑板腺功能障碍(MGD)相关的干眼症(DED)。Heng Qin ® 是首个且目前唯一获批用于治疗MGD相关干眼症的药物，未来数月将在中国面向患者上市。 根据《2023年中国MGD诊断与治疗专家共识》，目前尚无直接针对MGD的治疗药物 1 。《干眼诊断与治疗临床指南》显示，中国干眼症的发病率为21%-30% 2 。流行病学研究表明，69%-86%的干眼症患者属于蒸发过强型干眼症，而这一最常见的亚型主要由MGD引发 3,4 。Hengrui致力于满足临床对安全有效的MGD相关干眼症治疗药物的迫切且普遍的需求。 Heng Qin ® （全氟己基辛烷滴眼液）基于EyeSol ® 研发而成，该技术是全球首个不含水、辅料和防腐剂的药物技术 5,6 。凭借低表面张力的特性 5 ，它可以在眼表快速扩散 7 ，改善泪膜脂质层、抑制泪液蒸发并促进角膜上皮修复 8,9 。此外，全氟己基辛烷可补充脂质层中的非极性脂质，增加泪膜厚度并改善睑板腺功能 8,9 。 国家药品监督管理局对Heng Qin ® 的批准基于一项在中国患者中开展的多中心、随机、对照、双盲关键Ⅲ期临床试验 8 。研究显示，与活性对照药0.6%氯化钠溶液相比，Heng Qin ® 分别早在用药2周和第29天时显著改善了MGD相关干眼症患者的临床症状和体征。这一疗效持续至研究结束的第57天。研究结果表明，Heng Qin ® 安全性良好，耐受性佳，滴眼后眼部给药部位不良反应的发生率较低，与对照药相当。 2019年，Hengrui Pharma与Novaliq宣布达成战略合作，Hengrui Pharma获得全氟己基辛烷（研发代号：SHR8058滴眼液）在中国的独家研发、生产及商业化权利。全氟己基辛烷眼用溶液分别于2023年5月和2024年9月在美国和加拿大获批用于干眼症治疗。 关于Hengrui Pharma Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma)是一家创新型全球性制药企业，致力于高品质药物的研发和商业化，以应对未获满足的临床需求。Hengrui Pharma拥有由14个研发中心和5500余名专业人员组成的全球研发团队，重点关注肿瘤、代谢及心血管疾病、免疫及呼吸系统疾病、神经科学等治疗领域。截至目前，Hengrui已在中国上市23个新分子实体药物和4个其他创新药物。Hengrui Pharma成立于1970年，秉持以患者为中心的核心理念，始终致力于通过科技力量攻克疾病、改善健康、延长生命，为人类健康事业贡献力量。 关于 Novaliq Novaliq是一家私营生物制药公司，专注于同类首创及最佳眼科治疗药物的开发。Novaliq开发的EyeSol ® 是一种新型无水外用眼科药物。两款基于EyeSol ® 技术的干眼症治疗药物Miebo ® 和Vevye ® 已获得美国食品药品管理局批准并在美国上市，为患者护理带来革新。Novaliq的研发管线为眼科和视网膜疗法提供了多种发展机会。Novaliq总部位于德国海德堡，在美国马萨诸塞州剑桥设有办事处。其长期唯一股东是dievini Hopp BioTech holding GmbH & Co. KG，该公司是生命和健康科学公司的活跃投资者。更多信息请访问 。 参考文献 亚洲干眼学会中国分会、海峡两岸医药卫生交流协会眼科专业委员会眼表与泪液疾病学组、中国医师协会眼科医师分会眼表与干眼学组（2023年）。《中华眼科杂志》。2023年11月11日；59(11), 880–887。doi: 10.3760/ 《干眼诊断与治疗临床指南》。ISBN：9787523506189 Jie Y、Xu L、Wu YY、Jonas JB。《北京眼病研究中中国成年人干眼症患病率》(Prevalence of dry eye among adult Chinese in the Beijing Eye Study)。《眼科学（伦敦）》。2009年3月；23(3):688–693。doi: 10.1038/ Lemp MA、Crews LA、Bron AJ、Foulks GN、Sullivan BD。《基于临床患者队列的水液缺乏型与蒸发过强型干眼症分布情况：一项回顾性研究》(Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study)。《角膜》。2012年5月；31(5):472-8。doi: 10.1097/ICO.0b013e318225415a。 Tsagogiorgas C、Otto M。《半氟化烷烃作为新型药物载体——潜在医学及临床应用概述》(Semifluorinated Alkanes as New Drug Carriers-An Overview of Potential Medical and Clinical Applications)。《药剂学》。2023年4月11日；15(4):1211。doi: 10.3390/pharmaceutics15041211。 Sheppard JD等。莫哈韦研究组。《NOV03用于治疗睑板腺功能障碍相关干眼症的症状和体征：随机Ⅲ期莫哈韦研究》(NOV03 for Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction: The Randomized Phase 3 MOJAVE Study)。《美国眼科学杂志》。2023年8月；252:265-274。doi: 10.1016/ Agarwal P等。《评估半氟化烷烃对眼表和泪液动力学影响的临床前研究》(Preclinical studies evaluating the effect of semifluorinated alkanes on ocular surface and tear fluid dynamics)。《眼表》。2019年4月；17(2):241-249。doi: 10.1016/ Vittitow J等。《全氟己基辛烷（一种干眼症滴眼液）的体外蒸发抑制作用》(In Vitro Inhibition of Evaporation with Perfluorohexyloctane, an Eye Drop for Dry Eye Disease)。《当代治疗研究（临床与实验）》。2023年5月12日；98:100704。doi: 10.1016/ Steven P等。《半氟化烷烃滴眼液治疗睑板腺功能障碍所致干眼症》(Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease Due to Meibomian Gland Disease)。《眼科药物与治疗杂志》。2017年11月；33(9):678-685。doi: 10.1089/jop.2017.0042。 Tian L等。《全氟己基辛烷滴眼液治疗中国患者的睑板腺功能障碍相关干眼症：一项随机临床试验》(Perfluorohexyloctane Eye Drops for Dry Eye Disease Associated With Meibomian Gland Dysfunction in Chinese Patients: A Randomized Clinical Trial)。《美国医学会眼科杂志》。2023年4月1日；141(4):385-392。doi: 10.1001/jamaophthalmol.2023.0270。 任何产品/品牌名称和/或标识均为各自所有者的商标。© 2025 Jiangsu Hengrui Pharmaceuticals Co., Ltd.和德国海德堡Novaliq GmbH版权所有。保留所有权利。 免责声明：本公告之原文版本乃官方授权版本。译文仅供方便了解之用，烦请参照原文，原文版本乃唯一具法律效力之版本。
Business Wire
08-07-2025
- Health
- Business Wire
Breakthrough in Ophthalmology! Hengrui's Heng Qin® (Perfluorohexyloctane Eye Drops) Approved as First Treatment for Dry Eye Disease Associated with MGD
JIANGSU, China & HEIDELBERG, Germany & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jiangsu Hengrui Pharmaceuticals Co., Ltd. ('Hengrui Pharma'), a global pharmaceutical company focused on scientific and technological innovation, and Novaliq GmbH ('Novaliq'), a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol ® water-free technology, announce today that the China National Medical Products Administration (NMPA) has approved Heng Qin ® (Perfluorohexyloctane Eye Drops) for the treatment of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). Heng Qin ® is the first and only drug approved to treat DED associated with MGD and will be available to patients in China in the coming months. According to the Chinese Expert Consensus on MGD: Diagnosis and Treatment in 2023, there is no drug that directly targets the treatment of MGD 1. The incidence rate of DED in China is 21%-30% according to the Clinical Guidelines for Diagnosis and Treatment of Dry Eye 2. Epidemiology studies show that 69%-86% of DED patients suffer from evaporative DED, the most common disease subtype resulting from MGD 3,4. Hengrui aims to address the urgent and common clinical need for an effective and safe treatment for the treatment of DED associated with MGD. Heng Qin ® (Perfluorohexyloctane Eye Drops) is based on EyeSol ®, the world's first water-, excipient-, and preservative-free drug technology 5,6. Due to its low surface tension 5, it rapidly spreads over the ocular surface 7. It improves the tear lipid layer, inhibits tear evaporation, and promotes corneal epithelial healing 8,9. In addition, perfluorohexyloctane supplements nonpolar lipids in the lipid layer, increases tear film thickness and improves Meibomian gland function 8,9. The NMPA approval of Heng Qin ® was based on a multi-center, randomized, controlled, double-blind, pivotal phase 3 clinical study in Chinese patients 8. The study demonstrated that Heng Qin ® compared with an active comparator, 0.6% saline solution, significantly improved the clinical signs and symptoms of patients with DED associated with MGD as early as 2 weeks and at day 29, respectively. The effects were maintained through day 57, the end of the study. According to the study findings, Heng Qin ® is safe and well-tolerated. The incidence of instillation site reactions following administration of the eye drops is low and comparable to the study comparator. In 2019, Hengrui Pharma and Novaliq announced a strategic collaboration under which Hengrui Pharma secured exclusive rights to develop, manufacture, and commercialize perfluorohexyloctane (development name: SHR8058 eye drops) in China. Perfluorohexyloctane ophthalmic solution was approved as dry eye drug therapy in the United States and in Canada in May 2023 and September 2024, respectively. About Hengrui Pharma Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) is an innovative, global pharmaceutical company dedicated to the research, development and commercialization of high-quality medicines to address unmet clinical needs. With a global R&D team that includes 14 R&D centers and more than 5,500 professionals, Hengrui Pharma's therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience. To date, Hengrui has commercialized 23 new molecular entity drugs and 4 other innovative drugs in China. Founded in 1970 with the core principle of putting patients first, Hengrui Pharma remains committed to advancing human health by striving to conquer diseases, improve health, and extend lives through the power of science and technology. About Novaliq Novaliq is a private biopharmaceutical company focusing on the development of first- and best-in-class ocular therapeutics. Novaliq developed EyeSol ®, a novel drug category of water-free topical eye medicines. Two FDA-approved EyeSol ® medicinal products for dry eye disease – Miebo ® and Vevye ® – are on the market in the United States revolutionizing patient care. The Novaliq R&D pipeline provides multiple development opportunities in ophthalmology and retina therapies. Novaliq is headquartered in Heidelberg, Germany and has an office in Cambridge, MA, USA. The long-term single shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies. More on Reference Chinese Branch of the Asian Dry Eye Society, Ocular Surface and Tear Film Diseases Group of Ophthalmology Committee of Cross‑Straits Medicine Exchange Association, & Ocular Surface and Dry Eye Group of Chinese Ophthalmologist Association (2023). [Zhonghua yan ke za zhi] Chinese journal of ophthalmology. 2023 Nov 11; 59(11), 880–887. doi: 10.3760/ Clinical Guidelines for Diagnosis and Treatment of Dry Eye. ISBN: 9787523506189 Jie Y, Xu L, Wu YY, Jonas JB. Prevalence of dry eye among adult Chinese in the Beijing Eye Study. Eye (Lond). 2009 Mar;23(3):688–693. doi: 10.1038/ Lemp MA, Crews LA, Bron AJ, Foulks GN, Sullivan BD. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012 May;31(5):472-8. doi: 10.1097/ICO.0b013e318225415a. Tsagogiorgas C, Otto M. Semifluorinated Alkanes as New Drug Carriers-An Overview of Potential Medical and Clinical Applications. Pharmaceutics. 2023 Apr 11;15(4):1211. doi: 10.3390/pharmaceutics15041211. Sheppard JD, et al. MOJAVE Study Group. NOV03 for Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction: The Randomized Phase 3 MOJAVE Study. Am J Ophthalmol. 2023 Aug;252:265-274. doi: 10.1016/ Agarwal P, et al. Preclinical studies evaluating the effect of semifluorinated alkanes on ocular surface and tear fluid dynamics. Ocul Surf. 2019 Apr;17(2):241-249. doi: 10.1016/ Vittitow J, et al. In Vitro Inhibition of Evaporation with Perfluorohexyloctane, an Eye Drop for Dry Eye Disease. Curr Ther Res Clin Exp. 2023 May 12;98:100704. doi: 10.1016/ Steven P, et al. Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease Due to Meibomian Gland Disease. J Ocul Pharmacol Ther. 2017 Nov;33(9):678-685. doi: 10.1089/jop.2017.0042. Tian L, et al. Perfluorohexyloctane Eye Drops for Dry Eye Disease Associated With Meibomian Gland Dysfunction in Chinese Patients: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Apr 1;141(4):385-392. doi: 10.1001/jamaophthalmol.2023.0270. Any product/brand names and/or logos are trademarks of their respective owners. © 2025 Jiangsu Hengrui Pharmaceuticals Co., Ltd. and Novaliq GmbH, Heidelberg, Germany. All rights reserved.
Yahoo
20-03-2025
- Business
- Yahoo
Eyenovia Enters into Non-Binding Letter of Intent to Effect Reverse Merger with Betaliq
Combination, if successful, would create a new publicly-listed eye care company combining Betaliq's EyeSol® water-free drug delivery technology for glaucoma with Eyenovia's Optejet® device platform The combined company would continue marketing Eyenovia's FDA-approved products – and plans to in-license additional products to generate near-term revenue NEW YORK, March 20, 2025 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN) ('Eyenovia' or the 'Company'), an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet topical ophthalmic medication dispensing platform, today announced that it has entered into a non-binding letter of intent (LOI) contemplating a potential reverse merger transaction with Betaliq, Inc., a clinical stage pharmaceutical company with a therapeutic focus on glaucoma. The proposed merger would create a new ophthalmic company that combines two FDA-approved technologies: Betaliq's EyeSol® water-free drug delivery technology for use in glaucoma, and Eyenovia's Optejet topical ophthalmic liquid dispensing platform. The proposed transaction remains subject to completion of mutually satisfactory due diligence, the negotiation and execution of definitive agreements on mutually satisfactory terms, the approval of such definitive documentation by the boards of directors of both Eyenovia and Betaliq, and the completion of necessary financing contingencies. There can be no assurance that any such agreement will be executed or the proposed transaction with Betaliq will be consummated, or as to the timing of the entry of any such agreement or the consummation of such proposed transaction. The proposed transaction assumes a value for Betaliq of approximately $77 million and a value for Eyenovia of approximately $15 million, assuming zero cash (net of liabilities) at merger closing. The exchange ratio is intended to result in Betaliq equity holders owning approximately 83.7% of the combined company, while Eyenovia equity holders would own approximately 16.3% at the closing of the merger, on a fully diluted basis. Betaliq's EyeSol technology offers increased bioavailability and a drop size of 10 microliters that can be replicated in the Optejet device. The EyeSol technology is currently used and licensed in FDA-approved topical eye care medications, including MEIBO™ (perfluorohexyloctane ophthalmic solution, Bausch + Lomb) and VEVYE™ (cyclosporine ophthalmic solution 0.1%, Harrow) Eyenovia's Optejet dispensing platform, in addition to providing similar benefits to those provided by EyeSol, also may enhance the performance of products by making it easier to use and comply with therapy. Importantly, EyeSol is compatible with the Optejet. Eyenovia continues to advance development of the user-filled Optejet and remains on track to file for U.S. regulatory approval in the fourth quarter of this year. The user-filled Optejet is designed to work with a variety of topical ophthalmic liquids, including artificial tears and lens rewetting products. 'Following a review of strategic alternatives that we initiated in January, I, along with my fellow Board members, concluded that continuing the negotiation of this potential merger with Betaliq is in the best interests of our company, our team members, patients and shareholders,' stated Michael Rowe, Chief Executive Officer of Eyenovia. 'Under a combined new company, if the transaction is completed, our existing products could continue to be marketed to ophthalmologists and optometrists, while the combination of the EyeSol and Optejet technologies has the potential to create a platform that could fundamentally improve how topical eye medications and products are administered. We look forward to working with the Betaliq team on the completion of due diligence and the negotiation and potential execution of a definitive merger agreement in the coming weeks.' Barry Butler, Chief Executive Officer of Betaliq, added, 'This proposed merger with Eyenovia represents a significant opportunity in the eyecare space. The inherent synergies of the EyeSol and Optejet technologies could bring innovative new treatment options to patients with glaucoma as well as other ocular diseases. By leveraging the existing pipelines of Eyenovia and Betaliq with multiple opportunities for pipeline expansion through established partnerships, we believe we can build a leading ophthalmic company.' Eyenovia does not intend to discuss or disclose further developments regarding these discussions unless and until such definitive agreement is executed or its Board of Directors has otherwise determined that further disclosure is appropriate or required by law. Chardan is acting as advisor to Eyenovia in connection with the proposed transaction. Raymond James is acting as an advisor to Betaliq. About Betaliq, Inc., is a clinical stage pharmaceutical company with a therapeutic focus on Glaucoma, founded in 2018 through a collaboration with Novaliq GmbH. Betaliq is developing a global portfolio of topical glaucoma treatments based on the unique EyeSol® topical delivery system developed by Novaliq. This unique water-free eye drop technology offers increased residency time and enhanced bioavailability to provide the needed efficacy, while using less total drug. EyeSol® based eye drops are non-preserved not containing any chemical preservatives, like benzalkonium chloride, that can cause damage to the ocular surface, while being dispensed in a traditional multi-dose eye drop bottle. For more information, please visit About Eyenovia, Inc. is an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet topical ophthalmic medication dispensing platform. The Optejet is especially useful in chronic front-of-the-eye diseases due to its ease of use, enhanced safety and tolerability, and potential for superior compliance versus standard eye drops. Together, these benefits may combine to produce better treatment options and outcomes for patients and providers. The company's current commercial portfolio includes clobetasol propionate ophthalmic suspension, 0.05%, for post-surgical pain and inflammation, and Mydcombi® for mydriasis. For more information, please visit Forward Looking StatementsExcept for historical information, all the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to the potential transaction with Betaliq, our future activities or other future events or conditions, including those relating to the completion of due diligence on and a definitive transaction agreement with Betaliq, the estimated market opportunities for our platform technology, the timing for sales growth of our approved products, and the outcome of the process to explore strategic alternatives to maximize shareholder value. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and in some cases are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission. In addition, such statements could be affected by risks and uncertainties related to, among other things: the risk that the proposed transaction with Betaliq does not proceed; risks of our clinical trials, including, but not limited to, the potential advantages of our products, and platform technology; the rate and degree of market acceptance and clinical utility of our products; our estimates regarding the potential market opportunity for our products; reliance on third parties to develop and commercialize our products; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products; intellectual property risks; changes in legal, regulatory, legislative and geopolitical environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products and product candidates; our competitive position; and our ability to raise additional funds and to make payments on our debt obligations as and when necessary. Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake any obligation to update any forward-looking statements. Eyenovia Contact:Eyenovia, LoweVice President, Commercial Operationsnlowe@ Betaliq Contact:Betaliq, ButlerChief Executive Officerbbutler@ Eyenovia Investor Contact:Eric RibnerLifeSci Advisors, LLCeric@ 751-4363 Sign in to access your portfolio
