更新于：2024-05-01
Latanoprost
拉坦前列素
更新于：2024-05-01
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C26H40O5 |
InChIKeyGGXICVAJURFBLW-CEYXHVGTSA-N |
CAS号130209-82-4 |
关联
195
项与 拉坦前列素 相关的临床试验Evaluation of Latanoprost Combined With Fractional Erbium- YAG Laser Versus Microneedling in Alopecia Areata Treatment
Alopecia areata (AA) an autoimmune disorder of hair follicles results in varying degrees of scalp, facial and body hair loss.
Clinically, patients' presentation varies from patchy circumscribed scalp involvement to total body and scalp hair loss affects up to 2% of the general population.
The exact pathobiology of AA has still remained elusive, while the common theory is the collapse of the immune privilege of the hair follicle caused by immunological mechanism. Multiple genetic, environment factors and psychological stress contribute to the pathogenesis of Alopecia Areata .
Recent insights into the pathogenesis of AA have led to the development of new treatment strategies, such as Janus kinase inhibitors, biologics and several small molecular agents. In addition, modern therapies for AA, including antihistamines, platelet-rich plasma injection
Clinically, patients' presentation varies from patchy circumscribed scalp involvement to total body and scalp hair loss affects up to 2% of the general population.
The exact pathobiology of AA has still remained elusive, while the common theory is the collapse of the immune privilege of the hair follicle caused by immunological mechanism. Multiple genetic, environment factors and psychological stress contribute to the pathogenesis of Alopecia Areata .
Recent insights into the pathogenesis of AA have led to the development of new treatment strategies, such as Janus kinase inhibitors, biologics and several small molecular agents. In addition, modern therapies for AA, including antihistamines, platelet-rich plasma injection
开始日期2024-02-01 |
申办/合作机构 |
拉坦前列素滴眼液在中国健康受试者中的随机、开放、两制剂、单次给药、双周期、双交叉生物等效性试验
主要目的：评价中国健康成年受试者使用中国大冢制药有限公司生产的拉坦前列素滴眼液与Pfizer SA持证的参比制剂拉坦前列素滴眼液是否具有生物等效性。
次要目的：评价中国健康成年受试者使用中国大冢制药有限公司生产的拉坦前列素滴眼液的安全性。
开始日期2023-10-30 |
申办/合作机构 |
Assess the Safety, Tolerability and Efficacy of Latanoprost Liposome for Lower Eyelid Steatoblepharon
This trial is testing a drug to see if multiple injections to the undereye bags of selected patients decreases the volume of the eyebags as compared to placebo. Subjects will be randomized to receive either one of two doses of POLAT-001 or placebo. POLAT-001 will be injected into the eyebags at three of the visits. Each subject will attend 7-10 clinic visits over 98 to 140 days total to assess efficacy and safety.
开始日期2023-04-28 |
100 项与 拉坦前列素 相关的临床结果
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100 项与 拉坦前列素 相关的转化医学
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100 项与 拉坦前列素 相关的专利（医药）
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1,918
项与 拉坦前列素 相关的文献（医药）2024-02-17·Journal of pharmacological and toxicological methods
The visual field-testing maze and vision maze: Feasible techniques to evaluate visual field loss in animals.
Article
作者: Shivani Behera ; Ashmita Das ; Jaya Shree ; Pranay Soni ; Devi Prasad Pandey ; Surendra H Bodakhe
Visual field loss due to glaucoma is a severe and concerning problem, leading to limited visual range and poor quality vision. The progression of this loss begins with a para-central arcuate scotoma which eventually advances to a ring scotoma and constricted visual fields in later stages. Currently, no animal model is available for screening this pattern of vision loss. However, we have successfully developed two mazes to evaluate visual field loss - the visual field-testing maze (VFTZ) for peripheral vision loss and the vision maze (VM) for central vision loss. Our studies involved inducing glaucoma in Wistar and Sprague Dawley rats using lipopolysaccharide (LPS) and testing them in VFTZ and VM. We used Latanoprost and dorzolamide eye drops as standard drug candidates during the study. We evaluated the animals for intraocular pressure, retinal vasculature imaging, and anxiety using tonometry, ophthalmoscopy, and light and dark model techniques. Furthermore, we quantified the antioxidant parameters of the retina using UV spectroscopy. Our findings showed that animals with peripheral visual field loss in VFTZ took significantly more time to reach the goal and spent more time within the maze compared to normal or drug-treated animals (P < 0.001). Additionally, animals with compromised central visual field in VM spent more time in a particular arm and changed arms less frequently (P < 0.001) compared to normal or drug-treated animals. Moreover, we observed that glaucomatous rats exhibited elevated anxiety levels and impaired performance in the mazes, emphasizing the impact of vision loss on anxiety. Finally, the antioxidant and ATPase alterations in the retinal layers verified the glaucomatous changes in the experimental animals. Based on our remarkable findings, we strongly recommend the use of VFTZ and VM to evaluate visual field loss in animals.
2024-02-13·Journal of materials chemistry. B
A promising 'single' and 'dual' drug-nanocomposite enriched contact lens for the management of glaucoma in response to the tear fluid enzyme.
Article
作者: B N Kumara ; K Velmurugan ; M Vivek Ghate ; R Shambhu ; Jayabalan Nirmal ; K Sudhakara Prasad
Glaucoma is a neurodegenerative condition that results in the damage of retinal ganglion cells due to elevated intraocular pressure (IOP). To curtail the limitations associated with conventional treatments such as eye drops and ocular suspensions, we have developed 'single' and 'dual' drug delivery contact lenses (CLs), that is, latanoprost (LP) and latanoprost-timolol (LP-TM) deliverable CLs, in response to lysozyme (Lyz), which is abundant in the lacrimal fluid. Since chitosan (CS) can entrap more of the drug and also undergo hydrolysis in the presence of Lyz, we have employed CS for the composite preparation. The CL fabrication was performed by free radical copolymerization of poly(2-hydroxyethyl methacrylate) (pHEMA) in the presence of the drug-loaded nanocomposite with UV-curing initiators using the pre-drug loading strategy. The surface morphological, optical and mechanical investigations confirmed the presence of the drugs, ≥80% transparency, the adequate flexibility and biocompatibility of both the CLs. The in vitro release experiments showed the release of 95.86% LP from LP-CL, and 83.87% LP and 86.70% TM from LP-TM-CL in the presence of 1.5 mg mL-1 of Lyz in 72 h. In vitro biocompatibility assay against human corneal epithelial (HCE) cells and ex vivo experiments on HET-CAM confirmed that the fabricated LP-CL and LP-TM-CL are well tolerated. Moreover, in vivo safety evaluations of CLs on New Zealand white rabbit eyes suggest no sign of irritation to the ocular tissues within 72 h of observation. Hence, the study suggests that the 'single' and 'dual' drug-loaded CLs could open a new avenue to manage glaucoma by maintaining mean diurnal IOP.
2024-02-07·European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V
Combination of self-assembling system and N,O-carboxymethyl chitosan improves ocular residence of anti-glaucoma drug.
Article
作者: Velmurugan Kailasam ; Bommanahalli Nagaraju Kumara ; K Sudhakara Prasad ; Jayabalan Nirmal
Glaucoma is known to be one of the principal causes of vision loss due to elevated intraocular pressure. Currently, latanoprost eye drops is used as first-line treatment for glaucoma; however, it possesses low bioavailability due to rapid precorneal clearance. A novel delivery system with a mucoadhesive property could overcome this problem. Therefore, we attempt to develop a combination of self-assembling latanoprost nanomicelles (Latcel) and a mucoadhesive polymer (N,O-carboxymethyl chitosan: N,O-CMC) to improve the corneal residence time. Latcel was developed using Poloxamer-407 by thin film hydration method, followed by the addition of N,O-CMC using simple solvation to obtain Latcel-CMC and characterized using various physicochemical characterization techniques. The particle size of Latcel-CMC was 94.07 ± 2.48 nm and a zeta potential of -16.03 ± 0.66 mV, with a sustained release for 24h whereas marketed latanoprost drops released 90 % of the drug within 1h. In vitro cytotoxicity studies, HET-CAM, and in vivo Draize test showed the biocompatibility of Latcel-CMC. Cellular uptake studies performed using fluorescein isothiocyanate (FITC) loaded nanomicelles in human corneal epithelial cells indicates the increased cellular uptake as compare to plain FITC solution. In vivo ocular residence time was evaluated in Wistar rats using Indocyanine green (ICG) loaded nanomicelles by an in vivo imaging system (IVIS), indicating Latcel-CMC (8h) has better residence time than plain ICG solution (2h). The Latcel-CMC showed improved corneal residence time and sustained release of latanoprost due to increased mucoadhesion. Thus, the developed N,O-Carboxymethyl chitosan based nanomicelles eye drop could be a better strategy than conventional eye drops for topical delivery of latanoprost to treat glaucoma.
82
项与 拉坦前列素 相关的新闻（医药）2024-04-02
A first-in-class product, QLS‑111 is designed to lower intraocular pressure (IOP) beyond currently achievable levels in patients with glaucoma by targeting episcleral venous pressure (EVP)
DEDHAM, Mass.--(BUSINESS WIRE)-- Qlaris Bio, Inc. (“Qlaris”), a clinical-stage biotechnology company targeting unmet needs in debilitating ophthalmic diseases, today announced the initiation and dosing of two separate U.S. Phase II masked, randomized clinical trials investigating QLS‑111 in patients with ocular hypertension and glaucoma.
“The start of these Phase II trials represents a key milestone in our goal of bringing QLS‑111 to glaucoma patients for whom consistent IOP lowering and control has been an unachievable goal,” said Thurein Htoo, Chief Executive Officer. “IOP remains the only modifiable risk factor for the treatment of glaucoma, and additional treatments are needed for patients. QLS‑111 has the potential to change the treatment paradigm by effectively reducing IOP by lowering EVP, an unaddressed component of IOP.”
Qlaris is initiating the following studies:
The Osprey study (NCT06016972) will assess the safety, tolerability, and optimal dose of QLS‑111 compared with vehicle alone in adult patients who have primary open-angle glaucoma (POAG) and/or ocular hypertension (OHT). The efficacy of QLS-111 in lowering IOP will be assessed as a secondary endpoint of the trial.
The Apteryx study (NCT06249152) will evaluate the safety and tolerability, and measure the additive IOP-lowering efficacy, of QLS‑111 in combination with latanoprost versus latanoprost alone. Patients aged 12 years or older and who have open-angle glaucoma (OAG) and/or OHT currently on latanoprost will be enrolled in the trial.
“We are very pleased to initiate these studies in support of QLS-111 clinical development,” said Barbara Wirostko, MD, FARVO, Chief Medical Officer. “Despite the number of therapies currently available to clinicians, there remains a critical unmet need for new drugs that target unique parameters within IOP regulation with a strong safety profile. With a novel mechanism of action that targets EVP, as well as early data demonstrating it may be used in combination with existing treatments, QLS‑111 has the potential to make a significant impact.”
QLS‑111 is an ATP-sensitive potassium channel modulator that is designed to reduce IOP by reducing EVP and distal outflow resistance, making it potentially suitable for treating POAG, OHT, and normal tension glaucoma (NTG). Current medications fall into two categories, those that reduce aqueous humor production and those that target proximal outflow. However, none of the current medications directly address distal outflow and EVP. This is important as EVP contributes up to 50% of total IOP, often leaving patients unable to reach IOP reduction goals to slow their disease progression, despite currently available therapies. QLS‑111's complementary mechanism may offer a significant and synergistic advantage in managing IOP.
“I’m very excited about the promise of QLS‑111, which in healthy, normotensive volunteers lowered pressure significantly from baseline,” said Shan Lin, MD, Co-Research Director at the Glaucoma Center of San Francisco — a QLS‑111 investigational site — and a member of the Qlaris Scientific Advisory Board. “This suggests that QLS‑111 will benefit patients who do not adequately respond to currently available drugs due to the IOP floor set by EVP. Importantly, this compound has demonstrated that it can work alone or in combination with several current glaucoma drug classes, indicating that its use with current medications will aid in the ability to achieve levels of IOP reduction that slow disease progression. With its strong safety pro no clinically meaningful hyperemia, QLS‑111 holds enormous promise for our patients.”
About QLS‑111
QLS‑111 is a novel topical formulation using Qlaris Bio’s ATP-sensitive potassium channel modulator platform originally developed by Dr. Michael Fautsch, PhD, professor of ophthalmology, biochemistry, and molecular biology at Mayo Clinic, in Rochester, Minnesota. QLS-111 lowers IOP by relaxing vessels of the vascular and vascular-like tissues distal to the trabecular meshwork, thereby reducing distal outflow resistance and lowering EVP.
Though multiple mechanisms of action exist to lower IOP in patients with glaucoma, these agents target only three of the four components of IOP as described by the Goldman equation for IOP: the aqueous humor inflow rate, the uveoscleral outflow rate, and the conventional outflow facility. There are currently no approved drugs that selectively target the reduction of EVP. This leaves a significant gap in the potential to maximally lower IOP, since EVP can be the largest determinant of overall IOP.
Studies have demonstrated that treatment with QLS‑111 provides persistent lowering of IOP, maintains normal vascular integrity of the venous system, is well-tolerated, and thus far has shown it does not cause hyperemia.
About Qlaris Bio, Inc.
Qlaris Bio, Inc. was founded in August 2019 with a singular focus: to develop novel, innovative therapies with first-in-class mechanisms of action to address serious and debilitating ophthalmic diseases. The company’s lead program, QLS‑111, uses ATP-sensitive potassium channel modulators that improve outflow through distal vascular tissues of the eye to reduce IOP. Qlaris Bio’s investors include Canaan and New Leaf Venture Partners, both of which were co-lead investors in the company’s $25 million Series A funding round in August 2019. Other investors include Correlation Ventures and Mayo Clinic, where the science behind QLS‑111 originated. For more information, please visit .
临床2期
2024-04-01
·药通社
如今变更审批有何变化？有哪些值得参考的案例？药监老师参会！面对面答疑！点击上图，即刻报名！2001年，中国刚刚加入WTO，中国的医药外贸迎来了发展的黄金时代。20年间，医药出口市场总额增长近20倍。浙江医保、浙江省化工、全国的中化体系贸易商培育了大量的外贸精英人才。时代曾经辉煌。彼时，印度药是世界药房，卡了全世界的脖子；中国的原料药中间体特别是大宗原料药、大宗中间体卡了印度的脖子。作为世界上最大的仿制药出口国，印度70%的原料药进口自中国。疫情爆发后，由于中国原料供应受到影响，印度国内出现原料药供应中断、涨价的情况，引发了印度政府对药品短缺的担忧。而印度政府在2020年3月批准了PLI计划，以减少印度对中国生产重要抗生素、抗HIV药物、维生素和心脏药物的原料药的依赖。今年3月，印度更进一步，化学品和化肥部发布了《医药技术升级援助计划》，直接提出营业额激励计划以支持制药行业的技术升级工作。图 | 医药技术升级援助计划图源 | Invest India如今，医药外贸产业利润普遍被压缩到极致——商家此前由于出口受阻大量囤积原料药和中间体，开放后又大量放货，供需失衡，出口价格普降50%以上。21世纪会是印度的世纪吗？危——印度本土产业布局印度原料药产业链，如今自主可控非常成功。印度照搬了中国很多的模式，比如在药都海得拉巴，他们打造了产城融合模式的“张江园区”。阿拉宾度（Aurobindo）和Dr Reddy's都位于此。在印度境内排名第二的阿拉宾度2023年全年总收入34.47亿美元，较2022年增长7.95%。他们以化工原料起家，2005年以前几乎一直都在做原料药的生意，但此后开始向制剂转型。10年间，公司将制剂销售额从8%提升至80%，并且成功打开了美欧市场；2018年之后，阿拉宾度加大了对高附加值产品的布局，进一步强化了抗病毒药物管线和多肽药物管线，还以10亿美元为代价收购了Sandoz美国的皮肤治疗管线和多个仿制药产品包，随后又从TL Biopharma收购了5个biosimilar的产品包和从Spectrum Pharma买下了7个抗肿瘤药的产品包。除此以外，阿拉宾度的另一大布局就是打造OTC业务，在2021年的美国市场销售额中，肿瘤注射剂和OTC两大业务分别占到7%和6%的销售额。在高难度产品开发方面，该公司重点布局的就是吸入剂，相比印度其它巨头仍有明显的领先优势。而在印地区排名第一的太阳制药经营着品牌仿制药、仿制药和原料药三大业务。从地域上来看，在美国的制剂业务和在印度的品牌制剂业务是太阳制药收入最高的板块，占据了60%以上的份额。2022-2023年，太阳制药全年总销售额约合53.33亿美元，同比增长12.6%。净利润净利润约合14.44亿美元，相比去年同期的327.27亿卢比，增长了158.92%，利润水平达19.58%，可谓相当抢眼。眼科和皮肤科被作为重点打造的领域。皮肤科方面，太阳制药在收购Taro中获得了皮肤科仿制药产品包，后来又在收购Dusa中获得皮肤病专科药业务，2014年与默沙东达成了tildrakizumab的授权协议，此后又收购了日本Pola Pharma，进一步增强了其皮肤科的影响力。眼科方面，太阳制药在2015年之后收购了InSite Vision、Ocular Technologies，大幅加强了眼科产品线， BromSite/Megabrom（溴芬酸钠）、Cequa （环孢素）、Xelpros（拉坦前列素）等产品相继在美国上市，太阳制药的眼科-仿制药混搭产品线也初步形成。除了皮肤科和眼科，太阳制药布局的领域还有肿瘤科，他们自主研发了Yonsa（阿比特龙纳米晶制剂）、Docefrez (多西他赛注射液)、多柔比星脂质体等产品，从诺华收购了Odomzo（sonidegib），也初步形成了肿瘤科产品线。太阳制药是近5年来盈利水平最高的仿制药巨头之一，2016-2020年的平均净利润水平达13.6%，几乎达到了GSK等世界品牌药巨头的水平。但品牌创新药管线依旧还未形成。目前，印度在制剂的产业延伸速度越来越快，精细化工产业也全面构建转型，包括甾体激素和相关的原料药也能够进行研发和生产。很多人问，发酵类是否还有优势？印度气候炎热不适合发酵类原料药产品的生产，但如今这块在印度北部也有所布局。图 | 印度医药产业集群图图源 | Invest India此外，从侧面来说，从CPHI展会也可以看到印度厂商最近几年的变化：“小心印度人，印度药企在2022年CPHI Worldwide展位占了大部分，国内企业参展寥寥无几。欧洲客户私下告诉我，印度同行报价比你们低20-30%。这疫情三年，印度药企没有停下来，搞走我们不少客户。”药鼎记医药外贸直播嘉宾提醒道。中国对印度出口1300亿，进口印度药物200亿左右，消除贸易逆差也是他们当前的目标。二则，全球都在支持印度替代中国产业，欧美资金在印度很活跃。管理大师彼得‧杜拉克曾说，二十一世纪不是中国人的世纪，是印度人的世纪。他指出，印度是说英语的国家，很容易吸收西方知识，在学习西方国家的科学知识和先进技术方面比中国具有优势。另外，以美国为首的西方国家对印度有意扶植。留给我们的时间已经不多了。机——新的可能性现在对医药外贸来说，最容易想到的市场是印度，最有利润的是欧美，但是欧美印日之外的市场，依然海阔天空。很多早期业务把印度拿来练手，然后拓展到其他国家市场。医药是跟着政策的产业，如今跟着政治依然是方向所在，一带一路还有时间拓展。其中，行业人士提及，在企业调研时，他们发现越南等东南亚国家留给海外仿制药的市场空间已经不多了，诸多外贸企业已经将中东视为下一个必争之地。出于中东地区的经济潜力，多家跨国公司与中东当地制药公司合作，为创新药物进行本地化生产、技术转让和二次包装，向其他治疗领域如肿瘤、糖尿病、高血压和免疫性疾病等提供药物。在中东地区，跨国公司建立了不同的本地化模式。如沙特阿拉伯主要依靠技术研发及合作，而埃及、阿联酋、摩洛哥和约旦等国的助推力主要是当地生产设施建设。表 | 沙特制药本地化案例缩写：CV：海湾合作委员会；KAEC：阿卜杜拉国王经济城；KSA：沙特阿拉伯王国；MISA：沙特阿拉伯投资部；MoU：谅解备忘录；SAR：沙特阿拉伯里亚尔；SFDA：沙特食品药品管理局；SPIMACO：沙特制药工业和医疗器械公司药融圈某总对此表示，企业跳出现状看问题，才会有竞争力。从技术角度而言，连续流或者合成生物学等方向也一定要开始布局了。从模式而言，中国市场是全球最卷最残酷的市场之一，中国卷过的产品模式如果带到一带一路，可以降维打击。从贸易的角度看，医药是最高维度的产品，很难起量，但可以卷其他行业产品，比如保健品、甚至生活用品等新赛道。若能承担更高风险，可考虑并购、收购当地的医疗资源，打通销售脉搏；或与本土的合作伙伴建立合资企业，利用其政府背景，借力打力。风险最大的是独资模式，建议做好市场调研，并向已扎根于当地的央企、国企取经，做好风险预案。另外，中国企业应向印度学习。印度是仿制药大国，有更强的国际化驱动力，出海步伐更早，将国际规则吃得更透。从企业家角度来看，出海的不仅仅是产品，更需要的是产业链、解决方案。世界还很大，我们还有很多机会，需要抱团出海。资料来源：海国图智研究院《中国药企在中东市场的表现如何？》药事纵横《印度第二大仿制药巨头！阿拉宾度的成功发家与转型历程》GLG《进军中东非：医疗企业如何稳健出海？》推荐阅读点击下面图片，来聊聊细分风口：高端仿制药怎么走↓复杂注射剂、高端纳米制剂、脂质体药物、缓释微球药物……仿制药突破内卷有门路吗？
并购
2024-03-21
SHANGHAI, March 21, 2024 /PRNewswire/ -- On the evening of March 21st, OcuMension Therapeutics (Shanghai) Co., Ltd. (01477.HK, hereinafter referred to as "OcuMension" or the "Company") disclosed its 2023 annual performance report. The company achieved a total operating income of RMB 246.4 million for the full year, a year-on-year increase of 55.0%; with a comprehensive gross profit of RMB 144.4 million, representing a year-on-year increase of 40.3%. During the reporting period, the company's major operating indicators performed well, benefiting from rapid growth in sales revenue and further improvement in operational efficiency and cost control.
Enhanced Product Matrix, Rapid Expansion Leveraging First-mover Advantage
Adhering to the development philosophy of "providing world-class holistic solutions for pharmaceuticals," OcuMension has consistently devoted itself to identifying, developing, and commercializing innovative or best-in-class ophthalmic therapies. The company continuously enriches and expands its product matrix to meet the significant demand gap in Chinese ophthalmic medical care while maintaining its leading position in the ophthalmic track.
A diversified product matrix has laid the foundation for the company's steady growth. Leveraging its strong corporate strength, the company possesses a leading ophthalmic pharmaceutical platform with various drugs for both anterior and posterior segments, providing strong support for the company's development. Among them, the company's main products such as Ouqin (sodium hyaluronate eye drops), Emidin (timolol maleate eye drops), and Shilida (latanoprost eye drops) have all maintained steady growth.
Additionally, as one of OcuMension's outstanding products, OT-401(YUTIQ)® for the treatment of chronic non-infectious uveitis was successfully included in the medical insurance catalog in December of last year. It is reported that OT-401(YUTIQ)® completed the first domestic injection in December 2022, breaking the deadlock in the treatment of uveitis in China at that time, filling the treatment gap domestically, alleviating the burden on patients to the greatest extent, and marking the formal entry of the product into ophthalmic clinical applications.
It is worth noting that since OT-401(YUTIQ)® officially entered the medical insurance catalog on January 1st of this year, the company has rapidly promoted its medical insurance landing work nationwide with its comprehensive commercialization capabilities, bringing better and more affordable treatment options for uveitis patients. As of the disclosure date of the report, the terminal injection volume of OT-401(YUTIQ)® has exceeded the total for the previous year and is expected to continue to rapidly expand.
Overcoming Technological Peaks, Strengthening Self-defense with R&D Strength
To break the previous dominance of foreign capital in the Chinese ophthalmic drug market, the company continues to increase its investment in research and development, focusing on dual-source innovation, optimizing registration and development, promoting commercialization, and adhering to high-quality technical standards throughout the entire production cycle to ensure product safety, efficacy, and quality control.
With years of technological accumulation and industrial experience, in 2023, the company achieved several milestone breakthroughs with the assistance of clinical PI, including the submission of NDA for OT-1001 (timolol hydrochloride eye drops) accepted by CDE and included in the priority review program; completion of global patient enrollment for Phase III MRCT of OT-101 (atropine sulfate eye drops); completion of real-world studies for OT-502 (dexamethasone implant), currently in the Pre-NDA stage; the completion of patient enrollment for Phase II clinical trials of OT-202 (tyrosine kinase inhibitor), a self-developed drug for dry eye syndrome, in 25 experimental centers, with a total of over 700 patients enrolled during the year. This not only enriches the company's product pipeline but also provides more high-quality treatment options for patients.
The edge of technology stems from the strength of research and development behind it. Throughout 2023, the company invested a total of RMB 123.8 million in research and development, injecting strong momentum into the company's continued development. Meanwhile, the company also focuses on building a clinical research platform and constructing a research and development team to enrich the company's product pipeline and produce multi-level products that better meet patient needs. So far, the company has a total of 25 drug assets for both anterior and posterior segments, with 12 products already commercialized, covering both anterior and posterior segments and forming a strong product matrix in the fields of anti-allergy and glaucoma. Among them, five products in the company's pipeline are still in Phase III clinical trials, making it one of the companies with the highest number of Phase III clinical trials for innovative drugs in the Chinese ophthalmic drug market.
It is noteworthy that the company has made breakthrough progress in the research and development of the myopia drug Atropine recently. Faced with the challenge of stability, the company cleverly solved the long-term storage stability problem of low-concentration atropine sulfate solution by using a dual-chamber device of reconstitution solution and freeze-dried powder. Currently, the company's self-developed product OT-101-S (0.01% and 0.05% atropine sulfate eye drops) has had its Phase III clinical trial application accepted by CDE in China.
Accelerated Commercialization Process Provides Strong Support for Sales Revenue on the Sales Side
As one of the powerful driving forces for terminal sales, commercialization has also shown remarkable performance for OcuMension in terms of product hospitalization. In 2023, with a complete product pipeline, the company continued to expand hospital coverage and accelerate product hospitalization. Currently, the company has formed a nationwide sales network, covering 1558 tertiary hospitals, with a commercial team of over 230 people. On this basis, the company deeply explores the commercial penetration of strong products such as Shilida and Emidin, achieving rapid growth in sales revenue.
In addition, under the full play of national fiscal funds' guiding role in the development of innovative drugs, more approval resources will tilt towards high-value innovative drugs. With the company's increasingly mature commercialization process and the policy-driven tailwind, the company's image in the secondary market, previously underestimated, is expected to change. Within the month, the Hong Kong stock innovative drug sector has seen a full-scale increase, and the company gradually returned to a benign growth track in this round of valuation restoration of Hong Kong stock pharmaceuticals.
In the future, driven by multiple factors such as aging, electronic lifestyle, increasing medical awareness among patients, and rising resident payment levels, China's ophthalmic market has tremendous development potential. The company will rely on its first-mover advantage to rapidly enhance its competitiveness and penetration in the domestic market, while actively expanding overseas markets to enhance the company's international influence. By continuously deepening hospital cooperation, optimizing sales network layout, the company will further improve product coverage, providing more patients with high-quality and efficient medical services.
Chasing light and encountering, forging ahead. The development of innovative drugs in the field of Chinese ophthalmology is arduous but promising. With the continuous improvement in market recognition of the company's products, OcuMension will continue to uphold the development philosophy of innovation-driven and quality-oriented, continuously strengthen research and development investment, introduce more innovative and competitive products, strive to lead the market, and provide greater returns for investors.
SOURCE OcuMension
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研发状态
| 适应症 | 最高研发状态 | 国家/地区 | 公司 |
|---|---|---|---|
| 开角型青光眼 | 批准上市 | 美国 更多 | |
| 青光眼 | 批准上市 | 日本 更多 | |
| 高眼压症 | 批准上市 | 美国 更多 |
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床3期 | 156 | (繭蓋願簾窪憲壓簾襯膚) = 餘憲鹽願鑰製獵襯膚壓 憲構鏇築鏇淵鑰憲憲構 (網構獵範窪遞襯範醖願, 3.1 ~ 3.9) 更多 | 优效 | 2016-11-01 | |||
(繭蓋願簾窪憲壓簾襯膚) = 簾齋鏇糧鬱醖糧獵鬱夢 憲構鏇築鏇淵鑰憲憲構 (網構獵範窪遞襯範醖願, 1.2 ~ 2.0) 更多 | |||||||
N/A | - | 糧簾廠構淵鏇鬱蓋願糧(醖艱鑰製夢鹽壓壓醖壓) = 鑰淵積壓積範鬱鑰築簾 網積鹽鏇淵選簾願觸繭 (獵獵醖鹹簾範夢齋範願 ) | - | 2023-04-23 | |||
N/A | - | 構顧觸遞窪艱構鑰夢鬱(網鹽衊齋鏇膚願餘觸構) = 襯蓋糧築構獵築鬱衊齋 窪糧築獵製壓餘夢廠積 (廠鏇願鏇鑰鑰積壓蓋餘 ) 更多 | - | 2023-04-23 | |||
構顧觸遞窪艱構鑰夢鬱(網鹽衊齋鏇膚願餘觸構) = 淵蓋選壓繭鹹醖願鑰簾 窪糧築獵製壓餘夢廠積 (廠鏇願鏇鑰鑰積壓蓋餘 ) 更多 | |||||||
N/A | - | 壓製衊鹽獵醖顧願憲鹹(製襯積獵夢夢構齋糧餘) = 願築簾齋築顧鏇鑰構鏇 築網餘構餘製齋遞憲憲 (艱鏇願壓醖餘積鹽觸簾, ± 1.2) | - | 2020-06-01 | |||
临床3期 | 185 | (獵鬱鏇獵鏇糧構衊遞齋) = 鬱範壓膚顧廠壓蓋壓膚 夢遞構齋顧鬱膚構構膚 (艱顧網鹽獵製壓襯顧蓋, 2.3) | 积极 | 2021-11-14 | |||
(獵鬱鏇獵鏇糧構衊遞齋) = 築餘淵鬱憲齋製醖積艱 夢遞構齋顧鬱膚構構膚 (艱顧網鹽獵製壓襯顧蓋, 2.1) | |||||||
N/A | - | - | Latanoprost | 築蓋膚觸夢窪構蓋夢淵(糧夢膚範餘膚齋齋簾壓) = 醖齋製醖簾鹹鏇窪鏇網 艱願遞醖繭願襯願憲襯 (糧淵齋窪顧廠廠齋夢膚 ) | - | 2022-05-01 | |
Latanoprost | 築蓋膚觸夢窪構蓋夢淵(糧夢膚範餘膚齋齋簾壓) = 艱醖鬱鹹製醖鹹簾繭網 艱願遞醖繭願襯願憲襯 (糧淵齋窪顧廠廠齋夢膚 ) | ||||||
N/A | - | 106 | (膚憲築繭艱製窪餘選鏇) = 鑰壓齋鬱顧鏇壓憲衊憲 淵鏇網鑰鹹鹽範齋壓觸 (簾憲範鬱簾鹽簾築膚鏇 ) | 不佳 | 2021-06-01 | ||
(膚憲築繭艱製窪餘選鏇) = 膚膚艱廠遞繭鬱齋窪廠 淵鏇網鑰鹹鹽範齋壓觸 (簾憲範鬱簾鹽簾築膚鏇 ) | |||||||
临床2期 | 433 | (製觸鏇獵艱艱夢選醖蓋) = The most common adverse event was conjunctival hyperemia. There were no treatment-related serious adverse events or treatment-related systemic adverse events 廠壓鑰網築齋醖獵觸選 (製遞壓鬱範廠衊觸顧積 ) | 积极 | 2020-11-13 | |||
N/A | 107 | 餘膚網遞網壓艱壓遞壓(鹽糧膚鹹遞獵蓋築醖廠) = 顧艱窪壓淵鏇網觸蓋願 願淵窪鬱積鏇顧艱願製 (構範網鹽憲膚觸廠願襯 ) | - | 2023-04-23 | |||
临床3期 | - | (鏇餘淵鹽構糧憲夢淵憲) = 鏇築淵鏇窪鬱願範窪構 餘鏇鏇夢壓簾範壓顧憲 (選蓋築糧顧繭衊獵衊壓 ) 更多 | - | 2020-04-01 | |||
顧壓壓觸構憲糧願膚齋(蓋糧選鏇構獵夢構觸鬱) = 膚選艱鏇願遞遞襯構簾 餘齋範膚衊鬱餘窪鏇製 (築餘製製選鬱膚選構鬱 ) |
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