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HiST Pharma has been recognized by Life Sciences Review Magazine as the exclusive recipient of “Top 10 Therapeutics Companies in APAC - 2024,” based on our proprietary methodology, reflecting its position in the industry. This profile has been developed by the Life Sciences Review research and editorial team based on insights from an interview with Prof. Dr. Liping Yang, MD, CEO and Founder.

HiST Pharma
HiST Pharma

HiST Pharma

HiST Pharma公司简介:从植物临床应用研发的小微药业公司

传统中医药学与现代科学技术结合创新
传统中医药学与现代科学技术结合创新将将古老的传统医药智慧与现代科学技术融合,代表了一种独特而强大的创新方法与策略。 能够开启以前未曾探索的新药配方途径。这在HiST Pharma公司得到了完美体现,在这 里,医药创新在古老智慧与尖端科学技术的交汇处蓬勃发展。在杨利平教授的远见卓识领 导下,项目团队矢志不移,无畏艰辛,这家微型制药公司展现了在该领域真正的开拓者的 好奇心和专业精神。.

杨利平教授在制药界是一名普通人物,初期并无名气。他运用自己长期在基层临床医疗一 线工作实践积累的传统与现代医药学丰富经验,创立了HiST Pharma公司。这一具有前 瞻性的创业项目显示了他在医药实践和内行创业方面的深厚专业知识根底。.


杨教授多年来一直深度参与患者医护工作,为众多个人提供治疗,并获得了对各种治疗方 法的第一手见解。他突破了传统方法,将丰富的中医药遗产与现代科学技术相结合,研发 出了用于治疗银屑病等免疫介导疾病的植物新药和综合疗法。.

这一过程涉及利用植物药的潜在治疗潜力,提取具有已知疗效和安全性的活性药物成分 (API)。通过将这些天然植物临床应用经验与现代科学免疫技术结合,循证转化,杨教 授成功研发了HiST Pharma的旗舰产品——TC Cream,这是全球首个用于预防和治疗寻 常型银屑病及其他免疫介导的炎症性皮肤病的植物小分子药物。

“我们的药物源自植物,象征着纯净。其明确的API确保了安全性和疗效,为患者提供了病 情改善、缓解保证,使他们能够毫不犹豫地信任其远期疗效。”杨教授说道。

倡导促进探索银屑病防治管理的系统工程
世界卫生组织(WHO)将银屑病归类为一种慢性、痛苦、毁容且致残的非传染性疾病 (NCD),无明确原因或治愈方法。银屑病影响了全球超过一亿人,覆盖所有年龄段和 国家,报告的发病率范围从0.09%到11.43%,使其成为全球关注的问题。

传统的银屑病治疗主要依赖于靶向特定免疫调节剂或免疫抑制剂的生物制剂,具有显著的 风险和长期影响。HiST Pharma超越传统方法,开创了全球免疫调节局部药物和治疗模 式,解决银屑病发病机制中涉及的免疫通路。.

这些治疗模式基于中医药的基本原则,如天人合一、整体观念、辨证论治和未病先防。据 这些原则,人类不应被孤立看待,而是与自然相互联系,促进人与环境之间的和谐 。HiST Pharma提倡主动预防,开发考虑人体内在动态和外部环境影响的相应配方,以 塑造一个人的系统健康。.

“HiST Pharma旨在解决免疫介导疾病患者的未满足需求,创造积极的社会和经济影响。” 杨教授说道。

HiST Pharma不仅仅是空谈。公司积极研究银屑病和其他免疫学疾病的治疗。这些计划 得到了专有知识产权(IP)和一个大规模的健康产业链的支持,致力于新型小分子植物药 及相关产品的研发。为推动这一使命,HiST Pharma战略性地分配了资源,覆盖五个以 上的临床研究点,加速了对TC的深度研究,确保其治疗潜力的全面探索和验证。

逆向药物发现的开创性
HiST Pharma不仅开发创新产品,还在银屑病治疗中实现了可见的转变。尽管TC主要针 对轻中度病例,但公司的综合治疗和预防方案不仅提供症状缓解,还解决了长期管理的遗 传易感性问题。它以中医药为核心,为患者提供端到端的治疗方案。
HiST Pharma成功的核心是其颠覆性的“逆向药物发现过程”。与从零开始不同,公司利用 经过千百年人类使用验证的中药的安全性和有效性,提取出有效的API,制定药物,不仅 提高了疗效,还拓宽了治疗选择。公司拥有设备齐全的实验室和符合GXP认证标准的生 产设施,也通过项目不同任务组合建立了不同的合作团队。

“我们的逆向药物研发方法标志着一个变革性转变,加速了中医药现代化和产业化的进程 ,期望能为全球医疗和卫生社区做出贡献。”杨教授解释道。


这些方法的益处是显而易见且多方面的。它显著缩短了药物开发周期,加快了从概念到市 场的过渡。降低的研发成本提高了新药项目的经济可行性。它还提升了创新药物的安全性 和有效性标准,带来最佳的患者治疗效果。

HiST Pharma深刻理解开发过程和安全标准,能够扩大其业务,推动制药创新的边界。 但像HiST Pharma这样的微型公司如何与行业巨头竞争呢?答案在于公司的运营蓝图 ——一个可以与DARPA系统结构相比较的项目管理策略。

这里的重点从个人所有权转移到集体项目目标,着重于为特定项目需求组建有技能的团队 ,确保药物开发各阶段的高效推进。HiST Pharma作为一家小微公司,避免了跨国公司 常见的官僚主义,简化了从理念到商业化的旅程。

在一个成本可能高达数十亿美元的行业中,HiST Pharma以跨国制药公司的一个很小的 IND成本产出显著的成果。通过现代化中医药开发,加速产业化进程,为全球医疗和健康 社区做出了重要示范贡献。

多靶点免疫再平衡的TC Cream TC Cream源自天然植物蛇床子果实,系统性地再平衡免疫反应并恢复免疫稳态。与集中 于单一免疫细胞(细胞因子)的传统药物不同,TC的独特机制靶向多个自身免疫信号通 路,促进抗炎作用,同时抑制促炎介质。此多靶点方法影响身体的各个层面和系统,提供 了一个全方位的替代传统治疗的方案。

TC的一大优势是其无可挑剔的安全性,使其适用于年幼至两岁的儿科患者。这扩大了其 适用范围,对那些寻求有效且安全治疗选择的人产生了积极影响。天然植物化合物与现代 药物方法的结合,确保了疗效和最小毒性。该产品还可以与生物制剂一起使用,给患者提 供不干扰主要治疗的辅助选择。
TC Cream的开发历程堪称奇迹。在美国成功完成IIb期临床试验后,FDA授权HiST Pharma进行扩大III期临床试验,确立了该产品作为全球首个植物药物用于银屑病治疗的 地位。临床前研究显示其多方面特性,包括抗炎、抗过敏和止痒作用,以及调节表皮角质 形成的能力。TC Cream也被NMPA分类为新药。

治疗的整体方法
经验数据强烈表明,基于TC的衍生药物的益处远超银屑病,在治疗其他免疫介导的炎症 性疾病如特应性皮炎(AD)方面表现出希望。特别是头皮银屑病,这一尤其具有挑战性 的变体,因治疗选择有限而往往被忽视,已经成为HiST Pharma最新努力的焦点。公司 正在开发用于治疗指甲银屑病的药物,为受影响的患者提供有效治疗方案。HiST Pharma希望将其治疗范围扩大到银屑病以外,包括其他炎症性疾病如间质性膀胱炎—— 一种膀胱炎症障碍。

通过利用TC衍生物的巨大潜力,该公司致力于提供广泛的皮肤疾病综合治疗选择。由于 大约90%的银屑病患者初次被处方外用药膏,TC Cream的市场潜力巨大。它符合对可及 性和便利性的日益增长需求,尤其是在远程医疗的兴起下。通过局部应用,该产品减少了 对侵入性程序或频繁医疗咨询的需求。个人可以从流行的在线市场订购TC Cream,在家 中舒适地管理自己的健康。通过提供简单的自我给药说明,该产品正在使优质医疗保健的 获取民主化。

随着III期临床试验的推进,HiST Pharma离向全球数百上千万受这种毁灭性疾病困扰的人 展示TC Cream的益处越来越近。
治疗的成功
美国和中国的临床试验通常因老年人免疫系统的复杂性和相关风险而排除老年参与者。尽 管存在这些挑战,杨教授决心缓解该女性的痛苦。通过正确使用TC Cream,曾经遍布的 斑块消失了,展示了该产品的效力和无与伦比的安全性。

另一个引人注目的故事涉及HiST Pharma的独立董事会成员Daniel Zhu。他在接种五剂 COVID-19疫苗后免疫系统减弱,导致全身出现湿疹。由于不断的瘙痒和反复感染,他向 杨教授寻求指导,并开始使用TC Cream。两到三个月内,Zhu经历了显著的转变,湿疹 感染区域得到了治愈,为他带来了舒适和缓解。
  • Hist pharma aims to 杨教授讨论了TC Cream的效力,称:“我们的成功展示了植物药物的巨大潜力。HiST Pharma的开创性途径为更安全的临床化合物铺平了道路,标志着使用小分子治疗设计的 新纪元。”

HiST Pharma从一个远见卓识的想法到成为潜在的全球医疗领袖的旅程,展示了传统中 医药智慧与现代科学技术结合的力量。通过逆向药物发现和主动预防等创新方法,它将解 决未满足的医疗需求并改善了患者的结果。展望未来,HiST Pharma专注于药物的安全 性和有效性以及以患者为中心的医疗护理。在世界即将变革医疗保健格局之际,公司将为 全球无数民众提供更好的生活质量。

引文:
“HiST Pharma旨在解决免疫介导疾病患者的未满足需求,创造积极的社会和经济影响。” “我们的药物源自植物,象征着纯净。其明确的API确保了安全性和疗效,为患者提供了缓 解和保证,使他们能够毫不犹豫地信任其长期效益。” “我们的逆向药物发现方法标志着一个变革性转变,加速了中医药现代化和产业化的进程 ,为全球医疗和卫生社区做出了贡献。”

公司信息:
网站: histpharma.com 管理团队: 创始人兼CEO 杨利平教授,广州银屑病研究所主任医师 描述: HiST Pharma由杨利平教授创立,专注于开发用于银屑病和免疫介导皮肤病的植 物药物。其旗舰产品TC Cream是一种从天然植物中提取的局部植物新药,全球范围内用 于治疗银屑病。公司通过逆向药物发现过程,将中医药原则与现代技术相结合,确保通过 循证研究的疗效和安全性。这一创新方法加速了药物开发,为免疫介导皮肤病提供了全面 解决方案。

Prof. Dr. Liping Yang, HiST Pharma | Life Science Review | Top Therapeutics Companies in APACProf. Dr. Liping Yang, MD, CEO and Founder
The fusion of age-old traditional wisdom with contemporary medical sciences represents a unique and powerful approach to innovation that has the capacity to unlock new avenues for drug formulations that were previously unexplored and underexplored. This is very well personified by HiST Pharma, where innovation in medicine thrives at the intersection of ancient wisdom and cutting-edge science and technology. Under the visionary leadership of Prof. Dr. Liping Yang and relentless execution by the project team despite seemingly unsurmountable difficulties, the relatively small-sized pharmaceutical company embodies the spirit of curiosity and expertise that marks true pioneers in the field.

The leading figure in the HiST pharmaceutical section, Prof. Dr. Liping Yang, started as an ordinary medical doctor and a chief physician with little national or international fame in the pharmaceutical industry. He leveraged his extensive experience in traditional and modern medicine, which he had accumulated through decades of frontline clinical and medical practice, to found HiST Pharma. This forward-looking venture capitalized on his deep expertise in drug discovery, medical practice, and entrepreneurship.

Prof. Yang has been deeply involved in patient care for decades, attending to numerous individuals and gaining firsthand insights into various therapeutic approaches. Breaking away from conventional approaches, he integrates the rich heritage of Traditional Chinese Medicine (TCM) with modern science and technologies to develop state-of-the-art drugs and integrative therapies for immune-related diseases like psoriasis. This involved utilizing the latent therapeutic potential of botanical plants and extracting active pharmaceutical ingredients (APIs) well-known for their high efficacy and safety. By combining empirical clinical applications of these naturally occurring botanicals with modern immunological technologies and evidence-based translational medicine, Prof. Yang successfully developed TC Cream—HiST Pharma’s flagship product and the world’s first botanicalbased small-molecule drug for the prevention and treatment of psoriasis vulgaris and other immune-mediated inflammatory skin conditions. “Our drug, derived from plants, embodies purity. Its well-characterized APIs ensure safety and efficacy, offering relief and reassurance and empowering patients to trust its long-term benefits without hesitation,” says Prof. Yang.

TC Cream—formulated for topical application—offers a holistic remedy, harnessing the potency of plantbased compounds to modulate both local and systemic immunities. Multiple multi-center and large-population randomized clinical trials have been rigorously conducted to confirm its efficacy, enabling it to secure approval from regulatory bodies like China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA). TC Cream will serve as a lifeline for millions worldwide, promising safe and effective relief from psoriatic symptoms.

Advocating for a Systematic Approach to Promote the Exploration of Psoriasis Prevention and Long-term Management

The World Health Organization (WHO) has categorized psoriasis as a chronic, painful, disfiguring, and disabling noncommunicable disease (NCD) with no definite cause or cure. Psoriasis impacts over 100 million people across all age groups and countries, with reported rates ranging from 0.09 to 11.43 percent, making it a worldwide concern.

Traditional treatments for psoriasis, which primarily rely on immunosuppressants or biologics targeting specific immunomodulators, bear significant risks and long-lasting implications. Venturing beyond conventional approaches, HiST Pharma has pioneered global immunomodulatory topical drugs and therapeutic modalities that address the underlying immunological pathways involved in psoriasis pathogenesis.

The modalities are based on TCM’s foundational principles, such as natural compounds, holistic approaches, dialectical treatment, and disease prevention. According to these principles, a local medical condition should not be viewed in isolation but systemically interconnected with the entire human body, fostering harmony between individuals and disease conditions. Rather than passively awaiting the symptoms, HiST Pharma promotes proactive prevention, developing formulations considering the body’s internal dynamics and external influences shaping one’s health.

“HiST Pharma aims to address the unmet needs of patients grappling with immune-mediated diseases and create positive social and economic impacts,” says Prof. Yang.

HiST Pharma’s dedication is not just rhetoric. The company is actively researching treatments for psoriasis and other immunological conditions. These initiatives are backed by proprietary intellectual property (IP) rights and a large-scale health industrial chain dedicated to research and development (R&D) of new small-molecule botanical drugs and associated formulated products. To propel this mission, HiST Pharma has strategically allocated resources to over five clinical research sites, accelerating TC’s investigation and ensuring comprehensive exploration and validation of its therapeutic potential.

Pioneering Reverse Drug Discovery
HiST Pharma does not just develop innovative products; it enables a visible shift in psoriasis treatment. While the TC targets mild-to-moderate cases, the company’s comprehensive therapy and prevention protocol goes beyond symptomatic relief to address the genetic susceptibilities for long-term management. It offers end-toend therapy, with TCM at the core of patient care.

Our drug, derived from plants, embodies purity. its well-characterized apis ensure safety and efficacy, offering relief and reassurance and empowering patients to trust its long-term benefits without hesitation


Central to HiST Pharma’s success is its subversive ‘reverse drug discovery process.’ Rather than commencing from scratch and high-throughput drug screening, the company leverages the tried-and-tested safety and efficacy of TCM, which has been refined over centuries of human use. It facilitates the identification and extraction of potent APIs, enabling the formulation of drugs that not only enhance the effectiveness but also broaden treatment options. The company has fully-equipped labs and manufacturing facilities that adhere to cGXP-certified standards.

“Our reverse drug discovery approach heralds a transformative shift, accelerating the modernization of TCM and its industrialization journey, contributing to the global medical and healthcare communities,” explains Prof. Yang.

The benefits are tangible and manifold. The approach significantly shortens the conventional drug development cycle, expediting the transition from concept to market. Reduced research and development (R&D) costs improve the economic viability of new drug ventures. It also elevates the safety and efficacy standards of new medications, resulting in optimal treatment outcomes for patients.

A nuanced understanding of development processes and safety standards enables HiST Pharma to scale its operations and push the boundaries of pharmaceutical innovation. But how does a small player like HiST Pharma contend with industry giants? The answer lies in the company’s operational blueprint—a project-based strategy that can be compared to Defense Advanced Research Projects Agency (DARPA) systematic structure.

The emphasis here shifts from individual ownership to collective project objectives, focusing on assembling skilled teams for specific project needs and ensuring efficient navigation through various stages of drug development. HiST Pharma, being small and unencumbered by bureaucratic red tape, avoids the overhead often associated with multinational corporations, streamlining the journey from idea to commercialization.

In an industry where costs can spiral into billions, HiST Pharma produces remarkable results at a fraction of the IND cost incurred by multinational pharmaceuticals. Modernizing TCM development accelerates industrialization and contributes significantly to the global medical and health community.

Leveraging Multi-Targeted Immune Rebalance with TC Cream

Derived from the natural botanical Cnidium monnieri fruit, TC Cream locally and systematically rebalances the immune responses and restores immune homeostasis. Unlike conventional drugs focusing on individual immune cells and cytokines, TC’s unique mechanism targets multiple inflammation signaling pathways, fostering antiinflammatory effects while inhibiting pro-inflammatory mediators. This multi-target approach impacts various levels and systems of a body, offering a holistic alternative to conventional therapies.

One of TC’s key advantages is its impeccable safety profile, which makes it suitable for even pediatric patients as young as two years. It broadens the applicability of the disease and positively influences those seeking effective and safe treatment options. The blend of natural plant- derived compounds with modern pharmacy methods ensures both efficacy and minimal toxicity. The product can also be used with biologics, giving patients a complementary option that does not interfere with primary treatments.

  • Hist pharma aims to address the unmet needs of patients grappling with immune-mediated diseases and create positive social and economic impacts

The developmental journey of TC Cream has been nothing short of remarkable. Following a successful Phase IIb trial in the U.S., the FDA authorized HiST Pharma for an expanded Phase III trial, establishing the product as the world’s inaugural botanical drug for psoriasis treatment.

Pre-clinical studies have revealed its multifaceted properties, including anti-inflammatory, anti-allergic, and antipruritic effects, and its ability to regulate epidermal keratin formation. TC Cream has also been categorized as a new drug by NMPA.

A Holistic Approach to Treatment

The empirical evidence strongly suggests that the benefits of TC-based derivative drugs extend well beyond psoriasis, showing promising results in treating other immunemediated inflammatory conditions like atopic dermatitis (AD). Notably, scalp psoriasis, a particularly challenging variant often overlooked due to limited therapeutic options, has become the focus of HiST Pharma’s latest endeavors. The company is also developing drugs for nail psoriasis, offering effective therapeutic solutions for affected patients. HiST Pharma is looking to expand its therapeutic reach beyond psoriasis to include other inflammatory conditions beyond skin.

By leveraging the vast potential of TC-based derivatives, the firm is committed to providing comprehensive treatment options for a spectrum of skin ailments. Since approximately 90 percent of psoriasis patients are initially prescribed topical creams, TC Cream’s market potential is substantial in both inpatient and outpatient settings. It aligns with the growing need for accessibility and convenience, especially in the wake of telemedicine. The product mitigates the need for invasive procedures or frequent medical consultations through topical application. Individuals can order TC Cream from popular online marketplaces and take charge of their health from the comfort of their homes. The product democratizes access to quality healthcare by providing straightforward instructions for self-administration.

As the Phase III trial advances with the U.S. FDA, HiST Pharma edges closer to revealing the benefits of TC Cream to millions grappling with this debilitating disease worldwide.

Triumphs in Treatment

TC Cream has transformed the lives of many patients, relieving them of the burdensome symptoms of psoriasis and providing hope for a better quality of life. Among its numerous success stories is the inspiring account of an elderly woman afflicted by severe psoriasis, with her entire body covered in patches.

Clinical trials in the U.S. and China often exclude elderly participants due to the complexities of their immune systems and associated risks. Despite these challenges, Prof. Yang was determined to relieve the woman’s suffering. The oncewidespread psoriasis plagues disappeared with the proper administration of TC Cream, showcasing the product’s potency and unparalleled safety profile.

Another compelling story involves Daniel, an independent board member at HiST Pharma. His immune system weakened after administering five COVID-19 vaccine doses, resulting in eczema all over his body. Facing discomfort due to constant itching and recurrent infections, he sought guidance from Prof. Yang and began using TC Cream. Daniel experienced a remarkable transformation within two to three months as it healed the eczema-infected areas and brought him comfort and relief.

Prof. Yang discusses the potency of TC Cream, stating, “Our success with TC showcases the vast potential of botanical-based drugs. HiST Pharma’s groundbreaking pathway paves the way for safer clinical compounds and heralds a new era of efficacy in treatment design using small molecules.”

HiST Pharma’s journey from a visionary idea to a potential global healthcare leader demonstrates the power of TCM wisdom with modern science. Through innovative approaches like reverse drug discovery and proactive prevention, it addresses unmet medical needs and improves patient outcomes. As HiST Pharma looks forward, it focuses on drug safety, efficacy, and patient-centered care. On the verge of transforming the healthcare landscape, the company provides countless individuals with a better quality of life worldwide.

Top 10 Therapeutics Companies in APAC - 2024
Current Issue

Company : HiST Pharma

Management
Prof. Dr. Liping Yang, MD, CEO and Founder

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