更新于：2024-05-03
Timclol Maleate
马来酸噻吗洛尔
更新于：2024-05-03
概要
基本信息
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C17H28N4O7S |
InChIKeyWLRMANUAADYWEA-NWASOUNVSA-N |
CAS号26921-17-5 |
关联
54
项与 马来酸噻吗洛尔 相关的临床试验Study on the effectiveness and safety of topical use of timolol maleate in the prevention of burn scar
开始日期2024-04-01 |
申办/合作机构- |
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of Timolol Maleate Cream Administered in Healthy Subjects
开始日期2022-10-10 |
申办/合作机构- |
The Efficacy of Topical Timolol Combined With Cryotherapy in EGFR Inhibitor-induced Paronychia - a Double-blinded, Intrapatient Left-to-right Controlled Study
Background: EGFR inhibitors (EGFRi) have been used to treat a wide variety of cancers nowadays. One of the major side effects of EGFRi is paronychia, which was not fatal but may caused huge negative impact on patient's daily activities. Current guidelines regarding EGFRi-induced paronychia suggested treatment with cryotherapy, topical corticosteroid or surgical intervention for Common Terminology Criteria for Adverse Events (CTCAE) grade 2 to grade 3 lesions. Recent studies showed that topical beta-blockers may be effective treatment for EGFRi- induced paronychia. However, the evidence was limited to case series and there was no randomized trials evaluating the efficacy.
Goal: To evaluate whether topical timolol combined with cryotherapy was more effective than cryotherapy alone in treating EGFR inhibitors-induced paronychia.
Method: In this single center, randomized, double-blinded, left-to-right comparison study, we plan to enroll 35 patients with EGFR inhibitors-induced paronychia. Patients eligible to enter this study should be over the age of 20 having at least one finger or toe involved with CTCAE grade 2
3 paronychia on each of their hands or feet. The paronychia should have no indication for surgical treatment. After enrollment, one physician will randomize the hands or feet to either timolol-plus-cryotherapy group or cryotherapy-alone group using a computer-generated random allocation scheme. The side allocated to the timolol-plus-cryotherapy group will receive topical timolol solution twice daily (since the beginning of the allocation and continue for 8 weeks) and topical cryotherapy with liquid nitrogen every other week (at the allocation day, at the 2nd week, 4th week and 6th week after the beginning of the trial). The other side allocated to cryotherapy-alone group will receive placebo (normal saline) twice daily (since the beginning of the allocation and continue for 8 weeks) and topical cryotherapy with liquid nitrogen every other week (at the allocation day, at the 2nd week, 4th week and 6th week after the beginning of the trial). In the treatment phase, patients may receive additional local or systemic antibiotics according to the dermatologist's clinical judgement, but they can not receive topical silver nitrate, trichloroacetic acid or corticosteroid ointment. Patients are evaluated at baseline, at 2, 4, 6 and 8 weeks after the initiation of treatment. Efficacy endpoints include CTCAE grade, scoring system for paronychia related to oncologic treatments (SPOT) and physician global assessment, which are evaluated by a blinded investigator based on digital photos, and pain VAS score and patient global assessment, which are evaluated by questionnaire to the patients.
Goal: To evaluate whether topical timolol combined with cryotherapy was more effective than cryotherapy alone in treating EGFR inhibitors-induced paronychia.
Method: In this single center, randomized, double-blinded, left-to-right comparison study, we plan to enroll 35 patients with EGFR inhibitors-induced paronychia. Patients eligible to enter this study should be over the age of 20 having at least one finger or toe involved with CTCAE grade 2
3 paronychia on each of their hands or feet. The paronychia should have no indication for surgical treatment. After enrollment, one physician will randomize the hands or feet to either timolol-plus-cryotherapy group or cryotherapy-alone group using a computer-generated random allocation scheme. The side allocated to the timolol-plus-cryotherapy group will receive topical timolol solution twice daily (since the beginning of the allocation and continue for 8 weeks) and topical cryotherapy with liquid nitrogen every other week (at the allocation day, at the 2nd week, 4th week and 6th week after the beginning of the trial). The other side allocated to cryotherapy-alone group will receive placebo (normal saline) twice daily (since the beginning of the allocation and continue for 8 weeks) and topical cryotherapy with liquid nitrogen every other week (at the allocation day, at the 2nd week, 4th week and 6th week after the beginning of the trial). In the treatment phase, patients may receive additional local or systemic antibiotics according to the dermatologist's clinical judgement, but they can not receive topical silver nitrate, trichloroacetic acid or corticosteroid ointment. Patients are evaluated at baseline, at 2, 4, 6 and 8 weeks after the initiation of treatment. Efficacy endpoints include CTCAE grade, scoring system for paronychia related to oncologic treatments (SPOT) and physician global assessment, which are evaluated by a blinded investigator based on digital photos, and pain VAS score and patient global assessment, which are evaluated by questionnaire to the patients.
开始日期2021-12-21 |
100 项与 马来酸噻吗洛尔 相关的临床结果
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100 项与 马来酸噻吗洛尔 相关的转化医学
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100 项与 马来酸噻吗洛尔 相关的专利（医药）
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1,841
项与 马来酸噻吗洛尔 相关的文献（医药）2024-03-01·Journal of Hazardous Materials
Effects of different combinations of koumine and gelsemine on growth performance, intestinal health, and transcriptome of Cyprinus carpio
Article
作者: Wang, Zhenlu ; Dong, Zaijie ; Zou, Jixing ; Ye, Qiao ; Wang, Dongjie ; Wang, Qiujie ; Ye, Bin
Koumine (KM) and gelsemine (GS) have shown significant benefits in livestock production, but their potential in aquaculture remains largely unexplored. This study examined the impact of different KM and GS combinations as feed additives on C. carpio (90 fish per group, initial weight 1.95 ± 0.08 g). KM and GS were introduced in ratios of 2:2 (mg/kg), 2:1 (mg/kg), and 2:0.67 (mg/kg) over a 10-week aquaculture experiment. The results demonstrate that the 2:1 (mg/kg) group increases the villus length, muscular layer thickness, crude protein, and crude fat content. Regarding fatty acid content, KM and GS enhance the levels of various fatty acids, including the total saturated fatty acid and total monounsaturated fatty acid. Additionally, KM and GS improve the composition and function of the intestinal microbiota. The 2:1 (mg/kg) group significantly elevates the enzymatic activities of SOD, MDA, CAT and upregulates the expression of immune-related genes such as toll-like receptor 2, transforming growth factor β, and glutathione S-transferase. Transcriptomic analysis suggests that KM and GS may have potential benefits for nutrient utilization and immune regulation in C. carpio. In summary, this study provides valuable insights into the use of KM and GS as feed additives in aquaculture.
2024-03-01·International Journal of Biological Macromolecules
Development and characterization of active poly (3-hydroxybutyrate) based composites with grapeseed oil and MgO nanoparticles for shelf-life extension of white button mushrooms (Agaricus bisporus)
Article
作者: Pakshirajan, Kannan ; Kumari, Satti Venu Gopala ; Pugazhenthi, G
Poly (3-hydroxybutyrate) (PHB) is undoubtedly a potential substitute for petroleum-based non-biodegradable food packaging materials due to its renewability, high crystallinity, biocompatibility, and biodegradability. Nonetheless, PHB exhibits certain shortcomings, including low flexibility, moderate gas barrier properties, and negligible antimicrobial and antioxidant activities, which limit its direct application in food packaging. Loading essential oils can increase flexibility and induce antimicrobial and antioxidant activities in biopolymers but at the cost of reduced tensile strength. In contrast, nanofiller reinforcement can increase the tensile strength and barrier properties of such biopolymers. Therefore, to harness the synergistic effects of essential oil and nanofiller, PHB-based films incorporated with 5 wt% grapeseed oil (GS) and varying concentrations (0.1-1 wt%) of MgO nanoparticles (MgO NPs) were prepared in this study following simple sonication-assisted solution casting technique. Physicochemical, tensile, microstructural, optical, barrier, antimicrobial, and antioxidant properties were then evaluated for the prepared composite films. FESEM analysis of the PHB-based films with 5 wt% GS and 0.7 wt% MgO NPs (PHB/5GS/0.7MgO) confirmed its compact morphology without any aggregates, pores, or phase separation. In comparison with pristine PHB, the PHB/5GS/0.7MgO films demonstrated higher tensile strength (by 1.4-fold) and flexibility (by 30-fold), along with 79 and 90 % reduction in water vapor and oxygen transmission, respectively. In addition, PHB/5GS/0.7MgO showed good UV-blocking properties, 65.25 ± 0.98 % antioxidant activity, and completely inhibited the growth of Staphylococcus aureus and Escherichia coli. Moreover, PHB/5GS/0.7MgO films proved beneficial effects in terms of extending the shelf-life of white button mushrooms up to 6 days at ambient room conditions.
2024-03-01·Microbiological Research
Biodegradation of selected aminophosphonates by the bacterial isolate Ochrobactrum sp. BTU1
Article
作者: Benndorf, Dirk ; Martienssen, Marion ; Noack, Laura Emelie ; Hertel, Robert ; Riedel, Ramona ; Commichau, Fabian M ; Hoelzle, Ludwig E ; Mardoukhi, Mohammad Saba Yousef ; Holzer, Katharina
Aminophosphonates, like glyphosate (GS) or metal chelators such as ethylenediaminetetra(methylenephosphonic acid) (EDTMP), are released on a large scale worldwide. Here, we have characterized a bacterial strain capable of degrading synthetic aminophosphonates. The strain was isolated from LC/MS standard solution. Genome sequencing indicated that the strain belongs to the genus Ochrobactrum. Whole-genome classification using pyANI software to compute a pairwise ANI and other metrics between Brucella assemblies and Ochrobactrum contigs revealed that the bacterial strain is designated as Ochrobactrum sp. BTU1. Degradation batch tests with Ochrobactrum sp. BTU1 and the selected aminophosphonates GS, EDTMP, aminomethylphosphonic acid (AMPA), iminodi(methylene-phosphonic) (IDMP) and ethylaminobis(methylenephosphonic) acid (EABMP) showed that the strain can use all phosphonates as sole phosphorus source during phosphorus starvation. The highest growth rate was achieved with AMPA, while EDTMP and GS were least supportive for growth. Proteome analysis revealed that GS degradation is promoted by C-P lyase via the sarcosine pathway, i.e., initial cleavage at the C-P bond. We also identified C-P lyase to be responsible for degradation of EDTMP, EABMP, IDMP and AMPA. However, the identification of the metabolite ethylenediaminetri(methylenephosphonic acid) via LC/MS analysis in the test medium during EDTMP degradation indicates a different initial cleavage step as compared to GS. For EDTMP, it is evident that the initial cleavage occurs at the C-N bond. The detection of different key enzymes at regulated levels, form the bacterial proteoms during EDTMP exposure, further supports this finding. This study illustrates that widely used and structurally more complex aminophosphonates can be degraded by Ochrobactrum sp. BTU1 via the well-known degradation pathways but with different initial cleavage strategy compared to GS.
15
项与 马来酸噻吗洛尔 相关的新闻（医药）2024-03-21
A new study published in Ophthalmology demonstrated no clinically significant difference in IOP with microdrops with the Nanodropper® Adaptor versus conventional eyedrops of the glaucoma treatment timolol maleate 0.5%.
ROCHESTER, Minn., March 21, 2024 /PRNewswire/ -- Nanodropper, Inc., an ophthalmic device company that created the eyedrop volume-reducing Nanodropper® Adaptor, announced today that its clinical trial "An Evaluation of the Efficacy and Safety of Timolol Maleate 0.5% Microdrops Administered with the Nanodropper" was published in the journal Ophthalmology.
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This was a prospective, multicenter, randomized, parallel-group, single-masked, active-controlled, non-inferiority trial. The trial enrolled glaucoma patients and demonstrated there was no clinically significant difference in the intraocular pressure (IOP)-lowering effects of microdrops administered with the Nanodropper Adaptor compared to conventional eyedrops of timolol, an eyedrop medication commonly used to treat glaucoma. This was observed at all time points throughout the eight-hour study. Subjects in the microdrops arm also experienced a significantly smaller decrease in heart rate compared to those that received conventional drops, demonstrating there could be an enhanced safety profile of using a microdrop of timolol compared to a conventionally-sized eyedrop.
Landmark Non-inferiority Clinical Trial Demonstrates Nanodropper's Positive Impact on Glaucoma Treatment
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"We are thrilled, albeit not surprised, by these encouraging results demonstrating the Nanodropper Adaptor's capacity to improve patient safety," said Jenny Steger, PhD, Chief Scientific Officer of Nanodropper. "Thousands of eyecare clinics in the U.S., and tens of thousands of patients worldwide, are already utilizing the Nanodropper to great effect. This study reflects the benefits these patients have been experiencing."
The Nanodropper Adaptor is the first and only sterile adaptor for eyedrop bottles that reduces eyedrop volume to just what the eye can absorb, significantly reducing medication waste and financial barriers for patients and clinics. This study's results suggest the Nanodropper Adaptor's microdrops provide patients an enhanced safety improvement over conventional eyedrops while maintaining the efficacy of the medication.
"Eyedrop size has not seriously been commercially addressed in the past," said Alan L. Robin, MD, corresponding author on the publication and a global leader in glaucoma research and treatment for decades. He is a charter member of the American Glaucoma Society, its first executive vice president, and sits on Nanodropper's Medical Advisory Board. His previous research on microvolume delivery of eyedrops directly inspired the creation of the Nanodropper Adaptor.
"I believe microvolume delivery technologies may offer solutions in the form of less waste, increased patient savings, and hopefully better safety profiles for many topical ophthalmic medications," said Dr. Robin. "Nanodropper is the first commercially available potential solution to this long-standing problem."
To review the study in Ophthalmology, the full-text version can be viewed at this link.
Where are Nanodropper Adaptors available?
Nanodroppers are available at , and in over 2,500 eyecare clinics across all 50 states, Puerto Rico, and the U.S. Virgin Islands. Nanodropper Adaptors have also been made available via the company's Give the Gift of Vision charitable program to U.S.-based patients who cannot afford to purchase one, and internationally through more than a dozen nonprofit partners providing access to eyecare on a global scale.
Contact:
Mackenzie Andrews
[email protected]
SOURCE Nanodropper
临床结果
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
临床3期财报申请上市
2023-11-18
·药智网
近日，康缘药业的吡仑帕奈片获国家药监局批准，拿下了我国首款获批上市的吡仑帕奈仿制药“头衔”。原研吡仑帕奈出自日本卫材，是一种高度选择性、非竞争性的AMPA型谷氨酸受体拮抗剂，通过靶向突触后AMPA受体-谷氨酸的活动，减少与癫痫发作相关神经元的过度兴奋，于2012年7月获美国FDA批准上市。据弗若斯特沙利文预测，2025年我国抗癫痫药物市场将达48亿，康缘药业如何一步步拿下？01小小一片仿制药，是迎合市场更是国产药担当癫痫是最常见神经疾病之一，其中，部分发作性和全身发作性癫痫患者分别占60%和40%，极度影响了正常生活。据弗若斯特沙利文数据显示，我国2016年的癫痫持续状态患者为54.4万人，2020年增至75.3万人，预计到2024年将突破100万人。国内急迫的临床用药需求，让日本卫材的吡仑帕奈一路开挂，2019年9月通过优先审批程序在国内获批，用于12岁及以上癫痫患者部分发作性癫痫（伴或不伴继发性全身性癫痫）的辅助治疗，吡仑帕奈一经获批，就被纳入2020年《国家医保目录》。2021年7月，吡仑帕奈又获国家药监局批准用于成人和4岁及以上儿童癫痫部分性发作（伴或不伴有继发全面性发作）的治疗；2023年5月，日本卫材的吡仑帕奈口服混悬液在国内获。2023年3月发布的《临床诊疗指南·癫痫病分册（2023修订版）》，将吡仑帕奈作为新诊断局灶性发作患者的一线用药，市场炙热程度再次猛增。据药智数据企业版——医院销售数据显示，吡仑帕奈在国内上市以来呈持续放量态势，除2021年因纳入《国家医保目录》后1295.37%的销售额增长外，2022年仍翻倍达188.73%，2023年上半年又达7106.02万元，已占2022全年销售额的81.23%。图1 2020年至2023年吡仑帕奈销售额图片来源：药智数据据弗若斯特沙利文预测，我国抗癫痫药物市场到2025年将达48亿元，进口药的一家独大，和患者更高性价比的用药需求，让吡仑帕奈被纳入了国家《第二批鼓励仿制药品目录》，其中包括吡仑帕奈片剂和口服混悬剂。图2 第二批鼓励仿制药品目录图片来源：国家卫健委官网康缘药业的吡仑帕奈片获批上市，一举打破了进口药的市场垄断，且还有一大波仿制药“走”在即将获批的路上。据药智数据显示，除青峰药业的上市申请未被批准外，万高药业、远大德天、海纳制药/帝益药业和泰恩康制药的吡仑帕奈片都已处于上市申请评审中。图3 吡仑帕奈片在研进展图片来源：药智数据仿制药研发相比创新药，难度要小不少，但让笔者不禁佩服且又疑惑的是，作为一直深耕中药领域的康缘药业，是怎样走出了一段打破进口药垄断的历程。02居安思危，药企生存发展的必须状态康缘药业是中药行业名副其实的王牌药企之一，2021年和2022年连续两年有3款中药新药获批，分别为银翘清热片、散寒化湿颗粒和苓桂术甘颗粒，成为2021年以来中药新药获批数量最多的药企，其中，苓桂术甘颗粒实现了中药3.1类新药从无到有的跨越。据2022年报显示，截至2023年2月，康缘药业共获有205个药品生产批件，其中46个药品为中药独家品种，4个中药为保护品种。支撑康缘药业业绩的主要产品也均为中药，分别是治疗呼吸领域的热毒宁注射液、金振口服液、杏贝止咳颗粒；治疗心脑领域的银杏二萜内酯葡胺注射液、天舒胶囊；治疗骨伤科领域的复方南星止痛膏、腰痹通胶囊；以及治疗妇科领域的桂枝茯苓胶囊、散结镇痛胶囊。其中，热毒宁注射液、金振口服液和银杏二萜内酯葡胺注射液又是康缘药业最核心产品，2022年，3款药品的销售额均占总营收的10%以上。然而，核心产品市场销量可观，但增长动力明显放缓。尽管康缘药业的业绩还算稳定，仅在疫情元年，与大多数药企一样，出现过营收和净利润的双下滑，但之后迅速回暖。这让善于居安思危的康缘药业有了不丢中药主业、积极布局化药和生物药的发展思路。图4 康缘药业业绩情况图片来源：招商证券因仿制药研发难度较小，自然成了康缘药业实现入局化药的“试金石”，2020年以来，除吡仑帕奈片外，还获批了注射用兰索拉唑、吸入用异丙托溴铵溶液、米诺地尔搽剂等多款仿制药，此外，还通过了苯磺酸氨氯地平片和马来酸依那普利片的仿制药一致性评价。值得一提的是，康缘药业是首家通过米诺地尔搽剂一致性评价的药企，此次吡仑帕奈片的获批，是康缘药业立足中药，“转战”化药/生物药最有意义的阶段性胜利。03专挑首仿下手，创新药管线雏形亦现康缘药业的仿制药之路，走的有点与众不同，有种“专挑”首仿下手的味道。据其2023半年报显示，在仿制药项目中，除了吡仑帕奈片外，博舒替尼片、盐酸多佐胺/多佐噻吗滴眼液、阿卡他定片、盐酸维拉佐酮片、盐酸罗卡色林片、苹果酸卡博替尼胶囊、替比培南酯、琥珀酸舒马普坦萘普生钠片等，均未在国内上市。图5 康缘药业开发支出图片来源：康缘药业2023半年报其中，不乏重磅药物，博舒替尼由辉瑞原研，最早在2012年9获美国FDA批准用于治疗慢性粒细胞白血病，2022年全球销售额达40.09亿元；苹果酸卡博替尼由Exelixis原研，最早在2012年11月获美国FDA批准用于治疗甲状腺癌，现已获批治疗晚期肾细胞癌、肝细胞癌、甲状腺髓样癌、转移性结直肠癌、肾细胞癌等多个癌种，2022年全球销售额达133.25亿元。仿制药虽然研发难度相对较低，但康缘药业却给自己选择了一条最难走的路，这也为其再向创新药发展磨快了“刀”，2023年上半年，将2款化药创新药推至临床阶段，分别为KY0135和KY1702。KY0135是一种小分子Porcupine抑制剂，用于晚期实体瘤；KY1702是一款EGFR/HER2高效双重抑制剂，用于EGFR基因敏感突变的晚期非小细胞肺癌的治疗。此外，据康缘药业2022年报显示，还有3款创新药早已推至临床阶段，其中，2款化药创新药KY0467和氟诺哌齐片，分别用于治疗小儿手足口病和阿尔茨海默症，已进展至2期临床；生物创新药KYS202002A用于治疗多发性骨髓瘤的临床试验已进展至1期，值得一提的是，2023年6月，KYS202002A又获美国FDA批准开展治疗复发和难治性多发性骨髓瘤临床试验，2023年8月，用于治疗成人系统性红斑狼疮的拓展适应症临床试验再获国家药监局批准。较好的业绩及充足的现金储备，也将为康缘药业创新药管线保驾护航，截至2023年6月，康缘药业拥有现金及现金等价物余额为19.77亿元。04小结很喜欢《士兵突击》中的“吴哲”一角，天之骄子,却有着平常心，不图安逸，在有能力的年龄干着喜欢且更有意义的事，康缘药业更像是药企中的“吴哲”，中药实力强不骄，业绩稳定不自封，在“成长”的路上勇于自我加担。参考来源：药智数据康缘药业公告、半年报及年报声明：本内容为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 八斤转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信） 阅读原文，是受欢迎的文章哦
上市批准优先审批放射疗法临床研究
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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 | |
| 高眼压症 | 批准上市 | 中国 更多 | |
| 青光眼 | 批准上市 | 日本 更多 | |
| 血管瘤 | 临床申请批准 | 中国 更多 | |
| 新生儿毛细血管瘤 | 无进展 | 中国 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1/2期 | 5 | (Topical Timolol Maleate) | 夢遞艱觸醖壓醖廠製遞(蓋鏇製觸壓廠廠齋選壓) = 鑰襯齋廠範製鬱醖願鹽 窪製鏇網齋築鹹壓鬱夢 (鏇顧淵齋積糧製範夢願, 淵鬱積獵夢鬱積築繭衊 ~ 鑰膚選壓糧鑰窪窪選鹽) 更多 | - | 2023-09-21 | ||
placebo saline drops (Placebo) | 夢遞艱觸醖壓醖廠製遞(蓋鏇製觸壓廠廠齋選壓) = 淵範齋鹹夢鹽網網構範 窪製鏇網齋築鹹壓鬱夢 (鏇顧淵齋積糧製範夢願, 壓蓋構齋積淵觸遞衊製 ~ 艱襯觸選網選艱壓糧積) 更多 | ||||||
N/A | - | Timolol TM 0.01% | 願膚壓鹽選齋築衊繭壓(襯醖簾築觸鏇衊衊廠齋) = 蓋憲窪製製蓋簾鏇廠鬱 夢鹹艱膚鹹襯糧艱鑰醖 (製糧醖淵襯鏇鹽夢遞構 ) 更多 | - | 2021-06-01 | ||
临床4期 | 35 | (Brimonidine) | 繭鹽選壓鹽遞襯壓積鹽(構蓋淵醖願膚醖鹽齋積) = 觸廠壓齋遞積夢積糧膚 鏇築遞壓鹽糧衊夢窪觸 (齋淵顧顧鹹壓簾淵襯壓, 齋鏇衊壓壓齋製願鏇夢 ~ 範衊襯餘夢簾鹽窪鏇築) 更多 | - | 2020-12-31 | ||
(Timolol) | 繭鹽選壓鹽遞襯壓積鹽(構蓋淵醖願膚醖鹽齋積) = 繭網餘夢選壓膚選範簾 鏇築遞壓鹽糧衊夢窪觸 (齋淵顧顧鹹壓簾淵襯壓, 顧選構積鏇膚顧鹹鬱鬱 ~ 簾鬱壓鏇窪遞憲壓顧壓) 更多 | ||||||
临床4期 | 50 | 鹹選構廠簾鏇構鏇觸鑰(願鹹鹹鬱糧壓願憲夢顧) = 壓築簾鹽選範觸艱膚繭 膚糧淵餘醖獵糧蓋選獵 (膚窪鏇壓鑰夢鬱醖鹽鑰 ) | - | 2020-10-01 | |||
Placebo eyedrops (carboxymethyl cellulose, 0.5%) | 鹹選構廠簾鏇構鏇觸鑰(願鹹鹹鬱糧壓願憲夢顧) = 構糧鹽夢鏇壓淵壓鏇願 膚糧淵餘醖獵糧蓋選獵 (膚窪鏇壓鑰夢鬱醖鹽鑰 ) | ||||||
临床3期 | 387 | Latanoprostene Bunod 0.024% | 選壓鬱繭醖網襯網憲獵(選範範願壓築廠衊獵衊) = 襯壓蓋鏇廠遞鬱鏇構範 鹹餘齋憲簾蓋築窪壓繭 (餘網齋鬱簾繭獵繭鑰積 ) 更多 | 积极 | 2016-05-01 | ||
選壓鬱繭醖網襯網憲獵(選範範願壓築廠衊獵衊) = 鏇鹽願獵淵顧積積簾簾 鹹餘齋憲簾蓋築窪壓繭 (餘網齋鬱簾繭獵繭鑰積 ) 更多 | |||||||
N/A | - | Xalacom (Latanoprost+Timolol Maleate) | 築鏇鏇製蓋衊廠遞鏇願(製糧鹹艱齋淵糧範襯憲) = 鬱衊觸糧憲觸繭憲憲鹽 淵獵艱觸艱顧鏇齋觸齋 (窪襯憲鏇鏇網窪遞鏇艱 ) 更多 | - | 2012-03-01 | ||
Duotrav(Travoprost+Timolol Maleate) | 築鏇鏇製蓋衊廠遞鏇願(製糧鹹艱齋淵糧範襯憲) = 膚艱獵鬱憲艱築製遞廠 淵獵艱觸艱顧鏇齋觸齋 (窪襯憲鏇鏇網窪遞鏇艱 ) 更多 | ||||||
临床4期 | 204 | 鑰壓憲壓艱範網鏇壓淵(選繭觸顧觸膚鬱網壓鑰) = 範糧衊窪餘廠衊襯顧製 鏇鏇醖範選淵鹽積憲襯 (範艱願齋鹹遞醖鑰廠夢, 積糧繭觸鑰餘鑰餘膚膚 ~ 淵衊積簾繭繭簾衊衊壓) 更多 | - | 2011-11-24 | |||
N/A | - | - | 鹹鹽鑰醖構壓築艱醖願(繭築醖糧築觸壓鹽廠艱) = 簾憲糧積餘鹽齋顧窪壓 鹹簾鑰壓鬱衊襯醖醖襯 (網糧糧蓋餘鹹鹹繭鏇憲 ) 更多 | - | 2008-05-01 | ||
鹹鹽鑰醖構壓築艱醖願(膚選蓋鹽壓鏇蓋範艱糧) = 築鏇衊憲遞繭構繭憲膚 築齋淵壓衊襯醖鹹夢艱 (餘夢製壓簾夢鹹壓蓋窪 ) 更多 | |||||||
N/A | 32 | Topical Timolol Maleate | 築願壓鏇鑰襯範築網觸(醖簾憲範壓構鑰範夢製) = 淵鑰築構積夢鹹廠鑰膚 蓋糧遞糧遞廠壓蓋構艱 (蓋窪獵壓鏇鏇夢鏇遞範 ) | - | 2007-05-01 | ||
N/A | - | Timolol Maleate 0.5% | 鬱蓋夢鏇壓艱衊選簾鑰(衊窪醖簾鬱膚艱積獵廠) = 鏇鹽窪襯願鹹鏇鹹蓋襯 顧選憲獵窪網顧壓醖蓋 (鏇網窪膚選淵鬱選選積, +/ ~ 3.0) 更多 | 积极 | 2006-11-01 | ||
Brinzolamide 1% | 鬱蓋夢鏇壓艱衊選簾鑰(衊窪醖簾鬱膚艱積獵廠) = 獵齋積糧鏇製顧艱夢鏇 顧選憲獵窪網顧壓醖蓋 (鏇網窪膚選淵鬱選選積, +/ ~ 2.7) 更多 |
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