BCN Peptides SA

在国际化大趋势下，中国药企正面临一场必修课：如何高效“出海”，有效应对国际市场风云。而海森生物前不久的一起跨国收购则揭示了“国际化”新路径，备受业界瞩目。 产业界几乎没人怀疑，国内药企正加速“走出去”的决心。 在全球医药市场日益融合的背景下，国际化已成为药企竞相追逐的浪潮，这成为冲破存量桎梏、重塑产业竞争力的最佳路径之一。在这场行业国际化大趋势下，药企纷纷探索着各自的路径，往往多见自主出海或授权出海两大路径。 但纵使出海大军浩浩荡荡，其中磕磕绊绊者却不算少数。如何高效“走出去”，有效应对国际市场风云？仍是中国药企面临的一场必修课。 前不久，一起跨国收购背后的“国际化”新范式引起了产业界关注：海森生物完成对韩国生物制药企业Celltrion旗下14种品牌产品在亚太多个国家和地区商业权益的收购，并拥有这些产品在8个国家及地区的MAH权益。 不同于常规的新产品出海试水路径，海森生物选择了一条更为稳健且高效的国际化道路，为行业出海之路提供了新启示。然而，海森模式的成功并非简单复制即可，其背后有着独特的战略考量和市场逻辑。 01 铺设出海链路：从“引进来”到“走出去” 对于海森生物而言，这笔泛亚太地区大规模国际化收购背后，有着多重战略意义。 自诞生以来，海森生物便聚焦于慢性病及急重症领域未被满足的需求，致力于成为这一领域的领先生物制药企业。这种明确的战略定位使其能够集中资源，通过一系列引进收购，做大做强，在特定的治疗领域内快速发展。 本次对Celltrion旗下14种品牌产品的收购，更是丰富了其既有产品管线，加强在慢性病管理领域的市场竞争力。收购完成后，海森生物在高血压及糖尿病等慢性病领域完成多个经典产品布局，如易达比、倍欣、艾可拓、必洛斯和尼欣那。 实际上，搭建更全产品线只是其一，海森生物这一步棋的更重要意义在于加速商业化布局和推进国际化进程。 要知道，这家创新药企的长期策略是，打造具有国际商业化能力的全链条生物医药公司。回顾其发展历程，从最初的商业化优势凸显，到逐步构建研发与生产并行的全产业链闭环，再到国际化版图扩张，海森生物正加速布局全球，积极探索出海新路径。 近两年，海森生物的国际化进程明显加速，从一系列标志性事件得以窥见：2023年3月，德国全资子公司Hyberson Pharmaceuticals (Germany) GmbH.正式启动；同年12月，思他宁在瑞士的上市许可成功转移至瑞士全资子公司Hasten Biopharmaceutic (Switzerland) AG，标志着公司首次获得药品上市许可；进入2024年，与BCN Peptides、Alfasigma、默克等多家欧洲生物医药企业的合作进一步巩固了全球供应链基石。 而此次收购则正式拉开了其亚太布局的序幕，覆盖了包括韩国、新加坡、泰国、澳大利亚、中国香港等在内的8个国家及地区，开启全新的出海模式。过往，这家企业更多是引进产品进入中国，而此次通过“全产业链”和“全球化”战略进一步“走出去”，加速拓展泛亚太商业版图。 通过收购已上市产品意味着可直接利用现有的市场基础和供应链体系，避免了从零开始的市场培育和产品推广成本，同时这些产品原有的成功表现，也为海森生物快速切入新市场提供了有力支持，并逐步积累海森生物在泛亚太地区的品牌影响力和市场资源。 更长远的意义在于，海森生物通过一系列成熟产品的收购，积极铺设出海平台，将为后续创新产品的国际化铺路，形成一个良性循环的生态系统。相比起创新产品临时搭建国际化平台，预先打通的出海道路，这样的逻辑显然更为顺畅与高效。  正如CEO夏少斐所言，本次收购迈出了企业泛亚太商业布局的重要一步，也是公司在全球化进程中非常重要的里程碑。通过搭建跨越亚太多个地区、覆盖多个经典产品的商业布局，在拓宽了公司在泛亚太地区产品覆盖的同时，为未来更多优质产品的顺利出海铺平了道路。“这与我们一贯坚持的在海森速度的基础上‘稳中求进’发展策略是一致的。” 海森生物的创新路径不仅体现在高效铺设出海链路，其商业模式的创新之处也很早就显露峥嵘：通过不断打造商业化能力产生现金流，收购优质原研或高潜力在研产品，持续完善研发及生产能力，最终形成具有国际商业化能力、覆盖全产业链的战略布局。 这与一开始便专注于“研发”的初创药企有所不同，海森生物将商业化选做了起点，一旦资金到位便能迅速引进创新产品，充分利用经过市场检验的合作模式，积极推进与头部药商的战略合作，保证在商业化方面产生稳健的现金流，让有限的资源在市场上得到最大程度分配，不断放大自身优势。 正因其创新的商业模式，从而为其带来了强大造血力——商业化运营两年，实现业绩翻番，无疑也进一步提升了投资价值。毕竟，在当前医药资金市场紧缩的背景下，企业稳定的现金流和盈利能力更被投资者看重。 02 跃迁背后，探寻企业因何可以做到？ 纵观医药行业演进历程，从结果来看，海森生物的发展无疑是高效的。 自2022年开启商业化运营以来，短短800余日，这家“新星”药企就完成多个里程碑收购，以惊人的速度进行业务拓展和市场扩张，从最初强化商业化能力，迅速成长为集商业推广、研发、生产一体的跨区域biopharma；从最初的“引进来”，到而今“走出去”，实现了一场完美跃迁。 海森生物凭什么可以做到？这绝非偶然，背后离不开资方支持和海森速度的练就。 值得注意的是，甫一成立，海森生物便在医药圈是一个稍显与众不同的存在，背后坐拥强有力的资本方支持，亚洲专注于医疗健康行业投资的资产管理公司康桥资本、合肥产投集团和合肥市肥东县是其控股方。这与当前现金流吃紧的大多Biotech有着本质区别。 除了资金支持，康桥资本在大型跨境并购、平台建设、投后运营等方面的卓越能力与丰富经验，也为海森生物一系列并购决策提供不少参考意义。凭借独特的“投资者-运营商”模式，康桥资本将创新思维、丰富的行业经验和成熟的商业运营管理能力相融合，帮助被投企业寻找优质资产并进行国际化布局。 资方支持固然重要，但内部体系的高效运作也同样关键。若要复盘海森生物之所以能在激烈市场竞争中脱颖而出，“敏捷”或是其成功模式的核心关键词之一。 这一点在“短而高效的决策链”上表现得尤为明显，不仅渗透在并购与业务拓展的速度上，更贯穿于产品研发、生产及市场推广的全过程，成为企业快速响应市场变化、把握商机的关键优势。无独有偶，“敏捷”也是这家实干型企业重要的价值观之一。 究其原因，一是离不开管理团队敏锐的市场洞察力。这支大多出身外企的管理团队，拥有丰富的行业经验与敏锐的洞察力，能够在第一时间捕捉市场变化，迅速做出反应。二是内部独特的决策机制。跨国药企因体系庞大、流程繁琐，本土策略推行常需多层审批与协商。而海森生物则不同，其本土决策流程高效快捷，计划一旦确定即可迅速执行。 “决策链短”继而推动了“强落地”。过往一系列既有收购案例证明，公司有能力在短时间内完成被并购企业的员工承接和团队整合，并建立起完善的管理体系，确保业务平稳过渡和快速发展。 效果也立竿见影：2023年8月合肥生产基地获得药品生产许可证；2023年从LIB引进第三代新型长效PCSK9抑制剂Lerodalcibep，并于今年5月获CDE批准开展临床试验申请……这一系列里程碑事件的迅速达成，成为了“海森速度”的一大具象。 更关键的是，在保证了商业能力驱动下产生强大的造血力后，海森生物并非止步于此，更以“海森速度”开拓高速发展，如注重自我研发能力和生产能力的打造，从而形成全产业链的战略布局。 站在当下时间节点，回望海森生物发展轨迹，不难发现一切成功正得益于过往种种积累。无论是出生时与众不同的基因，资方强有力的支持，还是稳步打造具有国际商业化能力的全链条生物医药公司策略，并搭建了高效运转的内部体系，其模式和速度都在一次次里程碑中得到验证，相信也将为其未来发展铸就更多底气和优势。 一审| 黄佳 二审| 李芳晨 三审| 李静芝

Development Begins on Fourth Generation of Primary Drug TLR-AD1 Targeting CNS Tumors Potential for Improved Outcomes for Cancer Patients in the $100 Billion a Year Immune Oncology Market CLEVELAND, OH / ACCESSWIRE / July 27, 2023 / NovAccess Global Inc. (OTCQB:XSNX), a biomedical company developing novel immunotherapies for brain tumor patients, today announced the signing of a Letter of Intent (LOI) and formation of a partnership with BCN Biosciences to expand its immunotherapy platform. Utilizing BCN's small molecule drug BCN057, developed with support from the National Institutes of Health and in collaboration with the University of California Los Angeles (UCLA), NovAccess Global has begun the development of a fourth generation of its novel brain tumor immunotherapy TLR-AD1, targeting glioblastoma. Awarded Orphan Drug Status by the U.S. Food and Drug Administration in 2022, TLR-AD1improves the ability of specialized blood cells, known as Dendritic Cells (DCs), to recognize tumors. These specialized blood cells then provide a ‘zip code' to the immune system improving its ability to seek out and destroy tumor cells in the body. While TLR-AD1 is the most advanced technology to enhance DC immunotherapy, a combination therapy leveraging BCN057 could further enhance DC tumor recognition as well as increase DC yield from patients' blood. The partnership between NovAccess Global and BCN provides a unique opportunity to further develop BCN057 in combination with TLR-AD1 to benefit patients with CNS cancer and potentially other cancer tumor types. Based in Pasadena, CA and founded more than ten years ago, BCN Biosciences is a privately held oncology-focused drug development company leveraging long-term partnerships with NIH, Kansas University Medical Center, and UCLA. BCN has a portfolio of drug assets focusing on novel cancer targets and therapies that affect how cancer cells evade the body's immune system. BCN is currently developing two classes of novel small molecule drugs that target the RAS signaling pathway, a key molecular switch in the development of malignancies, and improve patient response to current classes of immune oncology therapy. "We are very excited to collaborate with BCN by applying its BCN057 drug to enhance NovAccess Global's immunotherapy platform technology," said NovAccess Global's Chief Executive Officer Dr. Dwain K. Irvin. "We already have very promising pre-clinical data and we need to officially partner with BCN to take this preliminary data one step forward. This partnership is vital to our efforts of advancing our technology as we move into and through clinical trials. As data supports, we expect to add to our patent and license portfolio which is expected to bolster our position as a key player in defining the next generation of immune oncology therapies. Once proven in brain tumor cellular therapy, our drug platform may be vital to other cancer tumor types." "BCN057 could make immunotherapies like TLR-AD1 even more effective by denying cancer cells the ability to evade the immune system," said Dr. Andrew Norris, BCN co-founder and Chief Scientific Officer. Dr. Norris, who also serves on the NovAccess Global Scientific Advisory Board, added, "The BCN team is excited to work with NovAccess Global to develop novel first-in-class technology that will overcome barriers to treat cancer and significantly benefit patients facing glioblastoma and CNS tumors worldwide." The partnership with BCN will further strengthen the IP portfolio supporting NovAccess Global's 4th generation of TLR-AD1. This partnership will increase opportunities for third-party licensing of NovAccess Global's drug platform to pharmaceutical companies active in developing new classes of therapies to compete in the global immune oncology market which today exceeds more than $100 billion a year. NovAccess Global plans to enhance TLR-AD1with its artificial intelligence (AI) driven Precision Medicine Division. Through this division, NovAccess intends to develop a comprehensive collection of personalized therapeutics and treatment protocols leveraging advances in bioinformatics, computational science, and molecular medicine. Clinical insights from the Precision Medicine Division will help to determine which drug variation based on the TLR-AD1 platform is most appropriate for patients to illicit the strongest and most durable immune response to their individual tumor type. About BCN Biosciences BCN Biosciences is a biopharma company with core competency in oncology drug discovery and development. BCN's mission is to improve cancer treatment by advancing new therapeutics that target specific mutations and immune system vulnerabilities. BCN Biosciences' experienced team of drug discovery and oncology experts is focused on the development and commercialization of a portfolio of small molecule therapeutic candidates. ​Currently BCN is developing drugs which target tumors driven by mutations in the RAS protein. KRAS mutant cancers represent over a quarter of all human cancers. These cancers are hard to treat because mutations in RAS make cancer cells more resistant to chemotherapeutic drugs as well as immunotherapies. This is most prominent in specific KRAS mutations such as G12C, G12D, G12V and G13D mutations. Such mutations cover a significant population of epithelial cancers patients, including almost half of colorectal, 80% of pancreatic, more than 30% of lung, a quarter of female reproductive cancers, as well as breast cancer. BCN is developing first-in-class therapeutics which target the oncogenic RAS pathway using a novel mechanism that restores the expression of a protein, phosphatase and tensin homolog (PTEN), in cancer cells. The advantage of this approach is that the inhibitors are less prone to RAS related drug resistance. Recent FDA approvals of KRASG12C inhibitors such as Amgen's (AMGN) LUMAKRASTM and Mirati's (MRTX) KRAZATI® have renewed the excitement in targeting the pathway. However, drugs targeting the greater patient population with KRASG12V and KRASG12D mutations have only very recently advanced beyond preclinical study status. BCN is targeting this large and unmet clinical need. BCN Biosciences also has an additional program in cancer immunotherapy, which includes first-in-class small molecules that inhibit or modulate the expression of PD-1 from within the T-cells that are present in the tumor microenvironment. This differs significantly from the existing industry model of blocking the interaction of PD-1 and PD-L1. In most cancers the response rate for such approach has been unsatisfactory and, in many cases has shown to exhibit toxicity. BCN's therapeutic approach may open new avenues to address patient segments who are currently not responding to monoclonal antibodies. About NovAccess Global NovAccess Global is a biomedical company accelerating novel cancer diagnostics and therapeutics. Our goal is to discover, develop and bring to market novel and innovative medicine and medical devices to improve the quality of care for cancer and neurological patients. NovAccess Global is currently developing a cancer vaccine therapy that enhances the patient's immune response against brain tumors. Our Company has a novel immunotherapeutic approach to treating brain tumor patients with glioblastoma, the most common adult brain tumor with a 15-month median survival after diagnosis. Our patented technology is designed to combine a dendritic cell-based immunotherapeutic approach with a unique combination of toll-like receptor (TLR) adjuvants, TLR-AD1, to help promote an enhanced immune response against the patient's tumor. Our platform technology focuses on enhancing the patient's immune cells to fight their unique cancer by utilizing the antigens specific to the patient's tumor. It is a meaningful technology that could significantly improve the quality of life and prognosis for the many people who suffer from brain tumors. For more information, please visit novaccessglobal.com. Follow us on social media and stay up to date on all of our developments: Forward-Looking Statement This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may," "future," "plan" or "planned," "will" or "should," "expected," "anticipates," "draft," "eventually" or "projected." You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in the Company's disclosures or filings with the Securities Exchange Commission. You are further cautioned that penny stocks and stocks of smaller companies like NovAccess Global Inc. are inherently volatile and risky and that no investor should buy this stock unless they can afford the loss of their entire investment. The Company disclaims any obligation to update any forward-looking statements to reflect events or circumstances after the date thereof. Investor Relations Contact: Jordan Darrow Darrow Associates 631-766-4528 jdarrow@darrowir.com SOURCE: NovAccess Global Inc. 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JERSEY CITY, N.J., June 16, 2022 /PRNewswire/ -- InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the " Global Neoantigen Peptides Manufacturing Market by Scale of operations (Research/Preclinical, Clinical, Commercial), by End-Users (Pharmaceutical/Vaccine developers companies, Contract Research Organizations (CRO), Academic and Research Institutes) - Trends, Industry Competition Analysis, Revenue and Forecast To 2030." According to the latest research by InsightAce Analytic, the global Neoantigen Peptides Manufacturing market is expected to grow with CAGR of 16.4% during the forecast period of 2022-2030. Request for Sample Pages: Neoantigen peptides are derived from the somatic mutation of a specific tumour. These peptides are used to activate the immune system of a cancer cell. In manufacturing neoantigen-based vaccines, personalized neoantigen peptides are synthesized, which helps induce the T-cell population. T-Cell Receptors(TCRs) recognize the HLA molecule on which neoantigen peptides are bound during the synthesis. Neoantigens are a recognized model of cancer vaccine delivery, and other types of immunotherapy are being studied to treat many types of cancer. Advancements in neoantigen production algorithms will consistently produce peptides for cancer research and drug development. Significant market factors of the Neoantigen peptide manufacturing are an increased number of favourable clinical trials, a rise in cancer and chronic disease cases, and the need for sustainable treatments for such diseases. In addition, biotechnology research advancements will enhance the study of personalized neoantigen peptides. External funding for cancer medicines' research and development also pushes the market upward. However, the market will be limited by the higher costs of designing and developing personalized cancer therapeutics and delayed clinical trials due to COVID-19's impact. Reduced process time and cost, treatment gaps, partnerships and collaboration between various healthcare stakeholders, and data analytics are expected to create growth opportunities for the neoantigen production market. Compared to Asia and Europe, North America dominates the market, leading to rapid research and development, rising cancer incidence and a growing need for improved treatment procedures. Enquiry Before Buying: Major key players operating in the neoantigen peptide manufacturing market are CPC Scientific Inc, Polypeptide group, Genscript Biotech, Kaneka Eurogentec S.A., Vivitide, Almac, BCN Peptides, Creative Peptides, Pepscan, Provepharm, Creosalus, Gyros Protein Technologies, Other Prominent Players. Key Developments In The Market: In Mar 2022, Pepscan announced that its specialists would manufacture the personalized peptide pools to treat cancer patients in Evaxion's phase IIb trial. Evaxion Biotech, a clinical-stage biotechnology company, recently published the initial results of the peptide-based personalized therapy EVX-01 in patients with metastatic melanoma. Pepscan had provided the personalized peptide pools for its phase I/IIa trial. In January 2021, Genocea announced a cancer discovery publication. The advantages of neoantigen identification using the ATLAS platform and this discovery strengthens neoantigen immunotherapies by theoretically certifying that they target the correct neoantigens while removing Inhibigens. In Apr 2020, GenScript company announced the commercial launch of its neoantigen peptide synthesis service for personalized cancer therapeutics. GenScript partnered with several T-cell therapy and personalized cancer vaccine companies to develop the infrastructure for reliably manufacturing complex peptides for its neoantigen peptide synthesis platform. In Feb 2019, CPC Scientific Inc., a leading global CDMO specializing in synthetic peptide manufacturing, announced today that they would manufacture GMP-grade neoantigen peptides for investigators at UNC Lineberger Comprehensive Cancer Center (LCCC) for individualized immunotherapy. CPC Scientific will supply GMP-grade neoantigen peptides, the sequences of which will be determined via genomics and bioinformatics, for use in the LCCC therapeutic neoantigen vaccine program. In Jan 2019, Almac group (CDMO)added a second stream for high output GMP peptide manufacture to its facility in Edinburgh, Scotland. The site manufactures Neoantigen-derived peptides to produce its personalized cancer vaccines. Market Segments Global Neoantigen Peptides Manufacturing Market, by Scale of operations, 2020-2030 (Value US$ Mn) Research/Preclinical Clinical Commercial Global Neoantigen Peptides Manufacturing Market, by End-users 2020-2030 (Value US$ Mn) Pharmaceutical/Vaccine developers companies Contract Research Organizations (CRO) Academic and research institutes Global Neoantigen Peptides Manufacturing Market, by Region, 2020-2030 (Value US$ Mn) North America Europe Asia Pacific Latin America Middle East & Africa North America Neoantigen Peptides Manufacturing Market, by Country, 2020-2030 (Value US$ Mn) U.S. Canada Europe Neoantigen Peptides Manufacturing Market, by Country, 2020-2030 (Value US$ Mn) Germany France Italy Spain Russia Rest of Europe Asia Pacific Neoantigen Peptides Manufacturing Market, by Country, 2020-2030 (Value US$ Mn) India China Japan South Korea Australia & New Zealand Latin America Neoantigen Peptides Manufacturing Market, by Country, 2020-2030 (Value US$ Mn) Brazil Mexico Rest of Latin America Middle East & Africa Neoantigen Peptides Manufacturing Market, by Country, 2020-2030 (Value US$ Mn) GCC Countries South Africa Rest of Middle East & Africa For Customization @: Other Related Reports Published by InsightAce Analytic: Global Peptide CDMO (Pharmaceutical) Market Global Neoantigen Cancer Vaccine Market Global Protein Design and Engineering Market Global Next-Generation Biomanufacturing Market Global Biopharmaceutical Excipient Manufacturing Market Global mRNA Synthesis and Manufacturing Services Market Why should buy this report: To receive a comprehensive analysis of the prospects for the global Neoantigen Peptides Manufacturing market To receive an industry overview and future trends of the Neoantigen Peptides Manufacturing market To analyze the Neoantigen Peptides Manufacturing market drivers and challenges To get information on the Neoantigen Peptides Manufacturing market size (Value US$ Mn) forecast to 2030 Significant investments, mergers & acquisitions in the Neoantigen Peptides Manufacturing market industry About Us: InsightAce Analytic is a market research and consulting firm that enables clients to make strategic decisions. Our qualitative and quantitative market intelligence solutions inform the need for market and competitive intelligence to expand businesses. We help clients gain a competitive advantage by identifying untapped markets, exploring new and competing technologies, segmenting potential markets, and repositioning products. Our expertise is in providing syndicated and custom market intelligence reports with an in-depth analysis with key market insights in a timely and cost-effective manner. Contact Us: InsightAce Analytic Pvt. Ltd. Tel.: +1 718 593 4405 Email: [email protected] Site Visit: Follow Us on LinkedIn @ bit.ly/2tBXsgS Follow Us On Facebook @ bit.ly/2H9jnDZ Logo: SOURCE InsightAce Analytic Pvt. Ltd.