杭州2023年8月9日 /美通社/ -- 凌科药业(杭州)有限公司(以下简称"凌科药业")是一家处于临床阶段的创新药研发公司。公司近日宣布LNK01001治疗特应性皮炎的II期临床试验取得积极的主要结果。
该研究是一项在成人(18-75周岁)中重度特应性皮炎(AD)患者中开展的随机、双盲、安慰剂对照、多中心的II期研究,纳入研究的受试者之前接受过AD外用治疗且临床应答不充分或接受过其他AD系统治疗。该研究由北京大学人民医院皮肤科张建中主任领衔完成。试验共纳入了150例患者,按 1:1:1随机分为3个试验组,分别为LNK01001高、低剂量组和安慰剂组。该研究的主要疗效终点是第12周湿疹面积和严重程度指数(EASI)评分较基线变化的百分比。
初步数据显示:在12周时,LNK01001高、低两个剂量组患者病情显著改善,湿疹面积和严重程度指数(EASI)评分较基线改善的百分比相比安慰剂组均有统计学差异,达到主要终点。此外,LNK01001高、低两个剂量组在达到EASI-75(EASI评分较基线下降≥75%)和研究者总体评估(IGA)应答[1]的受试者比例也均显著高于安慰剂组。改善皮肤瘙痒是提高特应性皮炎患者生活质量的重要指标,试验结果显示LNK01001对于瘙痒的改善起效迅速,给药后24小时,LNK01001高、低两个剂量组的瘙痒指数改善即显著优于安慰剂组。
在安全性方面:LNK01001高、低两个剂量组总体耐受性良好,CTC 2级及以上的TEAE和严重不良事件(SAE)发生率与安慰剂组相当,未报告MACE (主要心血管不良事件)、VTE(静脉血栓栓塞)和恶性肿瘤以及无严重感染报告。
该项研究的领衔研究者、中华医学会皮肤性病学分会第十三届主任委员、北京大学人民医院皮肤科主任张建中教授表示:"特应性皮炎是以慢性反复发作的瘙痒和多形性炎症性皮损为特征的疾病。控制瘙痒和清除皮损是AD患者的最迫切治疗需求,本研究的结果证明LNK01001有潜力为中重度AD成年患者提供临床获益,我们将继续深入研究,期待在Ⅲ期临床中进一步验证LNK01001的疗效和安全性,使更多患者受益。"
"随着社会的发展和生活习惯的改变,特应性皮炎的患病人数日益增加,全球特应性皮炎患者高达3.9亿人。我们很高兴看到LNK01001在治疗特应性皮炎试验中取得了积极的结果",凌科药业首席开发官吴昱博士表示:"公司近期将准备提交Ⅱ期临床试验结束(EOP2)/Ⅲ期临床试验启动前会议(Pre-Phase Ⅲ会议)申请,积极推进该产品的临床研究进度,力求尽早惠及更多患者。"
注:[1]:IGA应答定义为IGA达到0或1(皮损完全清除或基本清除)并且较基线改善≥2分。 |
关于凌科药业:
凌科药业成立于2018年,由来自辉瑞(Pfizer)、默沙东(Merck)和强生(Johnson & Johnson) 的资深药物研发专家和高管共同创立,是一个临床阶段的新药研发公司。公司致力于发现和开发用于治疗癌症以及免疫和炎症性疾病的创新药物。在更高目标的驱动下,凌科药业旨在成为市场领导者,通过开发创新疗法,满足未被满足的临床需求。至今为止,凌科药业自主研发的多款I类新药已经进入临床,并在全球展开了多个临床实验,如需了解更多关于凌科药业的信息请访问:https://www.lynkpharma.com。
杭州2023年7月21日 /美通社/ -- 凌科药业(杭州)有限公司(以下简称“凌科药业”)是一家处于临床阶段的创新药研发公司。公司近日宣布其自主研发的1类创新药LNK01004针对特应性皮炎的Ib期临床试验已完成首例患者给药。
该试验旨在评估LNK01004软膏在中国轻中度特应性皮炎成年受试者中多次局部给药后的安全性、耐受性、药代动力学特征以及初步有效性。
特应性皮炎是一种慢性、瘙痒性、炎症性皮肤病,临床特征包括皮肤干燥、红斑、渗出和结痂,以及苔癣样变。瘙痒是此病的标志,并且是给患者及其家人造成疾病负担的主要原因。全球特应性皮炎患者高达3.9亿人,中国患者5000万左右,其中大多数为轻中度病人。目前治疗以减轻症状(瘙痒和皮炎),防止病情加重并将治疗风险降至最低为主要目的。LNK01004软膏是一款外用皮肤限制性JAK抑制剂,药物主要在皮肤起效,起效快,系统暴露量极低,可避免由于药物全身系统暴露而带来的潜在安全性问题,具有同类首创(First-in-Class)的潜力(皮肤限制性)。目前LNK01004软膏已完成Ⅰ期健康人临床试验,试验结果显示出了较好的安全性;针对银屑病治疗的Ⅰb期临床试验正在进行中。
凌科药业首席开发官吴昱博士表示:“特应性皮炎是一种慢性疾病,病情往往迁延不愈,LNK01004软膏在临床前试验中显示了较好的疗效,健康人试验中安全性良好,将有可能为特应性皮炎患者提供更好的治疗方案,我们将积极推进该项目的临床研究进度,期待它在患者试验中的表现。”
关于凌科药业:
凌科药业成立于2018年,由来自辉瑞(Pfizer)、默沙东(Merck)和强生(Johnson & Johnson)的资深药物研发专家和高管共同创立,是一个临床阶段的新药研发公司。公司致力于发现和开发用于治疗癌症以及免疫和炎症性疾病的创新药物。在更高目标的驱动下,凌科药业旨在成为市场领导者,通过开发创新疗法,满足未被满足的临床需求。至今为止,凌科药业自主研发的多款I类新药已经进入临床,并在全球展开了多个临床实验,如需了解更多关于凌科药业的信息请访问:https://www.lynkpharma.com。
中国杭州2023年5月31日 /美通社/ -- 创新药研发公司凌科药业(杭州)有限公司(以下简称“凌科药业”),今日宣布顺利完成2亿人民币的C1轮融资。本轮融资由盛世投资、泰珑投资与联东投资共同参与。本轮融资将主要用于加速推进凌科药业核心产品的临床开发。
凌科药业成立于2018年,总部位于浙江杭州,是一家聚焦肿瘤及自身免疫疾病,致力于小分子FIC与BIC类药物研发的全球医药创新领军企业。公司核心团队拥有平均超过20年的新药研发或医药领域工作经验,在药物化学,生物学,临床与商业开发等方面积累深厚。公司在研管线布局上注重创新性与差异化。以第二代高选择性和第三代组织特异性JAK抑制剂的开发为核心,同时探索创新靶点成药性的可能。目前,公司产品有4个适应症处于临床II期,临床数据优势明显,其中多个管线即将进入临床III期。其他在研管线目前临床数据和临床前数据均十分优异,在多个适应症领域有能够成为BIC/FIC药物的潜力。背靠自身免疫疾病及肿瘤巨大市场,公司未来商业化潜力可期。
自身免疫疾病正成为继肿瘤之后的第二大疾病治疗领域,领域内的相关疾病拥有着巨大的未被满足需求。这一领域造就了多个重量级的药物。JAK抑制剂由于其明确的疗效与成药性,以及小分子自身区别于生物制剂的多个方面的优势,加上其药效好,起效快,正在全球范围内逐步受到临床医生和患者的欢迎。据弗若斯特沙利文预测,仅JAK1抑制剂市场在2030年将高达305亿美元,未来市场广阔。
凌科药业董事长兼首席执行官万昭奎博士表示:“感谢盛世投资、泰珑投资以及联东投资的信任与支持。凌科药业作为致力于在自身免疫疾病与肿瘤治疗领域开发具有全球竞争力与差异化的FIC/BIC创新药的企业,正处于高速发展的时期。我们将以这次融资为契机,继续深化在自身免疫疾病和肿瘤领域的研究,进一步加大对研发团队以及技术平台的投入,加速创新药物的开发和上市,为全球患者提供更多有效、安全的治疗方案。浩悦资本担任了本次融资的独家财务顾问,我们对他们的专业精神和支持表示感谢。”
关于凌科药业:
凌科药业成立于2018年,由来自辉瑞 (Pfizer)、默克 (Merck)和强生 (Johnson & Johnson) 的资深药物研发专家和高管共同创立,是一个临床阶段的新药研发公司。公司致力于发现和开发用于治疗癌症以及免疫和炎症性疾病的创新药物。在更高目标的驱动下,凌科药业旨在成为市场领导者,通过开发创新疗法,满足未被满足的临床需求。至今为止,凌科药业已经开发出多款自主研发的一类临床新药,并独立或携手国际合作伙伴在全球展开了多个临床实验 。如需了解更多关于凌科药业的信息请访问:https://www.lynkpharma.com。
关于盛世投资
盛世投资于2010年在北京成立,是中国母基金行业的先行者、领先者、布道者。基于全国性布局资源优势及专业投资管理能力,盛世投资构建了母基金、S基金、直投基金、项目制基金、并购及定增交易等多元化业务形态,致力于成为中国更懂管理和退出的私募股权投资管理机构。秉承市场化、专业化、产业化之道,盛世投资深度聚焦集成电路、新一代信息技术、医疗健康、先进制造、新能源、新材料等重点产业,投资覆盖天使、VC、PE、并购等全阶段,以创新引领产业转型升级,赋能实体经济高质量发展。多年来,盛世投资不断深入践行ESG投资,以实现经济效益、环境效益和社会效益多赢,打造机构长效竞争优势,携手合作方共赴可持续未来。
绍兴滨海新区管理委员会于2020年8月设立绍兴滨海新区生物医药产业股权投资基金,由盛世投资担任执行事务合伙人。基金按照“政府引导、市场运作、科学决策、防范风险”的原则开展运作管理,充分贯彻落实绍兴及滨海新区经济发展战略。基金总规模100亿元,主要采取“子基金+直投”模式进行投资,围绕建设绍兴生物医药“万亩千亿”新产业平台开展投资活动,支持市、区两级政府生物医药为主的新兴产业做大做强。
关于泰珑投资
泰珑投资成立于2021年,是一家专注于生物医药、医疗器械及大健康领域的专业股权投资管理机构,基金管理规模200亿元人民币。泰珑投资拥有一支专业、资深的投资团队,以生物医药、创新医疗器械、CXO核心服务及创新领域、优秀生物医药产业投资机构为重点投资方向,致力于打造忠于科学、跨周期的生物医药产业价值投资平台。
关于联东投资
联东集团创建于1991年,专注于产业服务和园区运营,已经发展成为具有全国影响力的产业集团。旗下核心企业联东U谷,目前在全国83座城市投资运营产业园区432个,引进、服务新兴制造业和科技型企业超过16000家。联东集团以自有资金通过直投和母基金方式重点投向于生命健康、智能智造、数字科技等战略新兴产业。
关于浩悦资本
浩悦资本创立于2014年1月,是中国领先的专注医疗健康行业的产业投行。公司总部位于上海,在北京和深圳设立区域办公室。浩悦资本始终致力于以资本助力,以研究驱动,帮助中国医疗行业优秀企业成功对接资本市场,为客户创造增值价值。浩悦资本的合伙人团队由深耕中国医疗健康领域多年的资深投资银行家组成,专业团队人数超过70名。浩悦资本长期密切追踪医疗健康投资市场动态和投资趋势,研究领域及交易范围覆盖创新医药、创新医疗器械、IVD与生命科学、健康服务和智慧医疗等多个细分赛道。2022年,浩悦资本完成了超过50笔私募融资、并购整合和上市公司分拆复杂交易,交易总额数百亿元人民币,在医疗行业各细分赛道全面领先。
HANGZHOU, China, Aug. 9, 2023 /PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as 'Lynk Pharmaceuticals'), an innovative clinical stage company, announced positive topline data from a Phase II clinical trial of LNK01001 for the treatment of atopic dermatitis.
The study was a randomized, double-blind, placebo-controlled, multicenter Phase II trial conducted in adult patients (aged 18-75) with moderate-to-severe atopic dermatitis (AD) who had previously received inadequate response to topical treatment for AD or had previously received other systemic treatment for AD. The study was led by Professor Jianzhong Zhang, Director of the Dermatology Department at Peking University People's Hospital. A total of 150 patients were enrolled in the trial. The patients were randomly divided into three trial groups at a ratio of 1:1:1, namely LNK01001 high-dose, low-dose, and placebo groups. The primary efficacy endpoint of the study was the percentage change from baseline in the eczema area and severity index (EASI) score at Week 12.
Preliminary data showed that after 12 weeks of treatment, patients in both the high and low dose groups showed significant improvement, with a statistically significant difference in the percentage change from baseline in EASI score compared to the placebo group, achieving the primary endpoint. Additionally, the proportion of responders achieving EASI-75 (≥75% improvement from baseline in EASI score) and Investigator's Global Assessment (IGA) response[1] were significantly higher in both high and low dose groups of LNK01001 compared to the placebo group. Improvement of pruritus is an important indicator of quality of life for patients with atopic dermatitis, and the results of the trial showed that LNK01001 had a rapid onset of improvement in pruritus, with both the high and low dose groups of LNK01001 showing significantly better improvement in pruritus indices than the placebo group at 24 hours after dosing.
In terms of safety, both high and low dose groups of LNK01001 demonstrated good overall tolerability, with comparable rates of CTC grade 2+ treatment-emergent adverse events (TEAE) and serious adverse events (SAE) compared to the placebo group. No major adverse cardiovascular events (MACE), venous thromboembolism (VTE), malignancies, or severe infections were reported.
Professor Jianzhong Zhang, the principal investigator of this study, the 13th Director in the Dermatology Division of the Chinese Medical Association and Director of the Dermatology Department at Peking University People's Hospital, said, "Atopic dermatitis is a disease characterized by chronic, recurrent pruritus and polymorphic inflammatory skin lesions. Controlling itch and clearing skin lesions are the most urgent treatment needs for AD patients. The results of this study suggest that LNK01001 has the potential to provide clinical benefits to adult patients with moderate to severe AD. We will continue to conduct further research and look forward to validating the efficacy and safety of LNK01001 in Phase III clinical trials to benefit more patients."
"With social development and lifestyle changes, the number of atopic dermatitis patients is increasing, with a global population of 390 million. We are pleased to see that LNK01001 has shown positive results in the treatment of atopic dermatitis", said Dr. Henry Wu, Chief Development Officer of Lynk Pharmaceuticals, "We are preparing to submit an application for the End of Phase II (EOP2)/Pre-Phase III meeting to advance the clinical development of this compound and strive to benefit more patients as soon as possible."
Note: [1]: IGA response is defined as achieving an IGA score of 0 or 1 (complete or near-complete clearance of skin lesions) and an improvement of ≥2 points from baseline.
About Lynk Pharmaceuticals:
Lynk Pharmaceuticals, a clinical stage company, was founded in 2018 by senior drug R&D experts and executives from Pfizer, Merck, and Johnson & Johnson. Lynk Pharmaceuticals is dedicated to the discovery and development of innovative drugs for the treatment of cancer, as well as immune and inflammatory diseases. Driven by a higher goal, Lynk Pharmaceuticals aims to be a market leader to address unmet medical demands by the development of innovative therapies. To date, Lynk Pharmaceuticals has independently developed several innovative new drugs and successfully completed a number of clinical studies. For more information about Lynk Pharmaceuticals, please visit: https://www.lynkpharma.com.
HANGZHOU, China, July 21, 2023 /PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as 'Lynk Pharmaceuticals'), an innovative clinical stage company, announced that it has dosed the first patient with atopic dermatitis in a Phase Ib clinical trial of its innovative drug LNK01004.
The trial was designed to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of LNK01004 ointment in Chinese patients with mild to moderate atopic dermatitis.
Atopic dermatitis is a chronic, pruritic, inflammatory skin disease characterized by dry skin, erythema, oozing, crusting, and lichenification. Itchiness is a hallmark of the disease and a major burden for patients and their families. There are as many as 390 million patients with atopic dermatitis worldwide, and about 50 million patients in China, most of whom are mild and moderate patients. Current treatments primarily focus on alleviating symptoms (itching and dermatitis), preventing exacerbation of disease, and minimizing treatment risks. LNK01004 ointment is a topical, skin-restricted JAK inhibitor, primarily acting on the skin with rapid onset of action and minimal systemic exposure, thereby avoiding potential safety concerns associated with systemic drug exposure. It has the potential to be a first-in-class treatment with skin-restricted properties. LNK01004 ointment has completed Phase I clinical trials in healthy subjects, demonstrating a good safety profile. Phase Ib clinical trials for the treatment of psoriasis are currently underway.
Dr. Henry Wu, Chief Development Officer of Lynk Pharmaceuticals, said, "Atopic dermatitis is a chronic disease with a protracted course of symptoms. LNK01004 ointment has shown promising efficacy in preclinical studies, and good safety results in the healthy volunteer study. We believe it has the potential to be a better treatment for patients with atopic dermatitis. We are actively advancing the clinical development of this program and look forward to its performance in patient trials."
About Lynk Pharmaceuticals:
Lynk Pharmaceuticals, a clinical stage company, was founded in 2018 by senior drug R&D experts and executives from Pfizer, Merck, and Johnson & Johnson. Lynk Pharmaceuticals is dedicated to the discovery and development of innovative drugs for the treatment of cancer, as well as immune and inflammatory diseases. Driven by a higher goal, Lynk Pharmaceuticals aims to be a market leader to address unmet medical demands by the development of innovative therapies. To date, Lynk Pharmaceuticals has independently developed several innovative new drugs and successfully completed a number of clinical studies. For more information about Lynk Pharmaceuticals, please visit: https://www.lynkpharma.com.
HANGZHOU, China, May 31, 2023 /PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as 'Lynk Pharmaceuticals'), an innovative clinical stage company, today announced the successful completion of a RMB 200 million Series C1 financing round. There was joint participation by China Grand Prosperity Investment, Tailong Capital and Liando Investment. The proceeds from this round of financing will be primarily used to accelerate the clinical development of Lynk Pharmaceuticals' core products.
Founded in 2018 and headquartered in Hangzhou, China, Lynk Pharmaceuticals is a global innovative leader in the pharmaceutical industry dedicated to the development of small molecule FIC and BIC drugs for oncology and autoimmune diseases. The company's core team has deep knowledge in medicinal chemistry, biology, clinical and commercial development, with an average of more than 20 years of experience in new drug research and development or related disciplines in the pharmaceutical industry. The company emphasizes innovation and differentiation in its pipeline, with a focus on the development of highly selective second-generation and tissue-restricted third-generation JAK inhibitors while exploring drug development with novel targets. Currently, the company has 4 Phase II clinical trials for four indications with promising clinical data. Among these, a few programs are expected to enter Phase III clinical trials in the near future. Additional pipeline candidates have shown promising clinical and preclinical data and have the potentials to become BIC/FIC drugs for several indications. Recognizing the significant medical needs in the market of autoimmune diseases and oncology, the company sees great potential for commercialization of its products.
Autoimmune diseases are emerging as the second largest therapeutic area after oncology. There are huge unmet needs for autoimmune related diseases which has led to the creation of a few "blockbuster" drugs. JAK inhibitors are gradually becoming the preferred choice for clinicians and patients around the world due to their validated therapeutic effects and convenience of use. In addition to multiple intrinsic advantages associated with small molecules over biologics, the JAK inhibitors are well known for favorable efficacy and fast onset. According to Frost & Sullivan, the total market size of JAK1 inhibitors alone will reach $30.5 billion by 2030.
Dr. Zhao-Kui (ZK) Wan, Chairman and CEO of Lynk Pharmaceuticals, said, "We are grateful for the trust and support from China Grand Prosperity Investment, Tailong Capital and Liando Investment. Lynk Pharmaceuticals is committed to developing globally competitive and differentiated FIC/BIC innovative drugs for autoimmune and oncology diseases. In this period of rapid growth, we will take this opportunity to further strengthen our research and development in autoimmune and oncology diseases and to increase the investment in our R&D team as well as our technology platform. Lynk will continue to look for opportunities to accelerate the development and launch of innovative drugs in the hope of providing more effective and safer treatment options for patients worldwide. HaoYue Capital acted as the exclusive financial advisor for this financing. We are sincerely thankful for their professionalism and support."
About Lynk Pharmaceuticals:
Lynk Pharmaceuticals, a clinical stage company, was founded in 2018 by senior drug R&D experts and executives from Pfizer, Merck, and Johnson & Johnson. Lynk Pharmaceuticals is dedicated to the discovery and development of innovative drugs for the treatment of cancer, as well as autoimmune and inflammatory diseases. Driven by a higher goal, Lynk Pharmaceuticals aims to be a market leader to address unmet medical demands by the development of innovative therapies. To date, Lynk Pharmaceuticals has independently developed several innovative new drugs and successfully and completed a number of clinical studies. For more information about Lynk Pharmaceuticals, please visit: https://www.lynkpharma.com.
About China Grand Prosperity Investment
Founded in Beijing in 2010, China Grand Prosperity Investment (Prosperity Investment ) plays an important role as a pioneer, leader and advocator of China's FOFs. Based on the advantages of national layout resources and professional asset management capabilities, Prosperity Investment has developed diversified business models such as FOF, secondary fund, direct investment fund, case fund, M&A and PIPE. Prosperity Investment is committed to growing into a local private equity asset management institution which has a better understanding of management and exit strategies in China. Adhering to market-oriented, professional and industrialized approach, Prosperity Investment has a core focus on strategic emerging industries such as semiconductor, new generation of information technology, healthcare, advanced manufacturing, new energy, and new materials. Their investments cover all stages ranging from angel, VC, PE, to M&A, and aim to promote industrial transformation and upgrading through innovation, empower the high-quality development of better economy. Over the years, Prosperity Investment has always adhered to the ESG investment philosophy, aiming to achieve win-win economic, environmental and social benefits, including building long-term competitive advantages and work alongside our partners for a sustainable future.
Shaoxing Binhai New Area Management Committee established the Shaoxing Binhai New Area Biopharmaceutical Industry Equity Investment Fund in August 2020. Prosperity Investment acted as the executive affairs partner. The fund operates and manages according to the principles of "guidance from government, market operation, scientific decision-making, and risk prevention", fully implementing the economic development strategy of Shaoxing and Binhai New Area. The total size of the fund is 10 billion yuan. It mainly uses the "sub-fund + direct investment" model for investment and invests in the construction of Shaoxing's new industrial platform of "10,000 acres of land, 100 billion yuan" in the biopharmaceutical industry, to support the development and growth of emerging industries led by the biopharmaceutical industry at the municipal and district levels.
About Tailong Capital
Founded in 2021, Tailong Capital is a professional equity investment management institution focusing on the biopharmaceutical industry, medical devices and healthcare. It manages funds of RMB 20 billion. With a professional and experienced investment team, Tailong Capital is dedicated to biopharmaceuticals, innovative medical devices, CXO core services, innovative businesses and outstanding investment institutions focusing on the biopharmaceutical industry. Tailong Capital is committed to building a scientific and cross-cycle value investment platform for the biomedical industry.
About Liando Investment
Liando was founded in 1991, focusing on industrial services and park operations, and has developed into an industrial conglomerate with nationwide influence. Its core enterprise, Liando U Valley, currently invests and operates 432 industrial parks in 83 cities across the country, attracting and serving over 16,000 emerging manufacturing and technical companies. Liando strategically invests its own funds in key emerging industries through direct investment and venture capital funds, such as life and health sciences, intelligent manufacturing, and digital technology.
About HaoYue Capital
HaoYue China Healthcare Fund is a private equity investment fund specializing in China healthcare. With the help of HaoYue Capital's investment banking business, HaoYue China Healthcare Fund invests in healthcare companies with extraordinary growth potential. They empower the success of their portfolio companies and serve investors with returns above market average. They invest in leading companies in key areas across biopharma, medical devices, healthcare services & digital health, and IVD & precision medicine. HaoYue China Healthcare Fund is a private equity investment fund, specializing in China healthcare.