Psilocybin

ROUND ROCK, Texas, Dec. 3, 2025 /PRNewswire/ -- Benuvia Operations, LLC (Benuvia), a global contract development and manufacturing organization, today announced a strategic partnership with Cannovation Clinical Research Partners (CCRP), a global consultancy focused on cannabinoid and psychedelic therapeutic programs. Together, the organizations will create the industry's first fully integrated manufacturing and contract research organization (CRO) platform dedicated to Schedule I–V substances. The collaboration combines Benuvia's end-to-end capabilities in controlled-substance manufacturing, analytical testing, and CMC development with CCRP's expertise in preclinical and clinical research, regulatory strategy, and global trial execution. Through this partnership, pharmaceutical and biotech clinical trial sponsors gain a single, compliant pathway from early-stage development through commercialization for cannabinoid, psychedelic, and novel CNS therapeutics. "Benuvia has spent years building a scalable, compliant, and highly specialized manufacturing platform for controlled-substance innovation," said Terry Novak, CEO of Benuvia. "Partnering with CCRP allows us to align GMP production with coordinated clinical and regulatory execution, eliminating many of the barriers that slow development and improving the speed and efficiency with which sponsors can advance these important medicines." An Integrated Pathway from Discovery to Commercialization Historically, companies developing controlled-substance drugs have been forced to work with separate vendors for preclinical studies, clinical trials, regulatory support, and GMP manufacturing—creating delays, redundancies, and regulatory friction. Through this partnership, sponsors gain: Streamlined IND-to-trial transitions supported by aligned regulatory and operational oversight More efficient timelines through reduced vendor fragmentation and harmonized compliance standards Access to global clinical trial networks spanning North America, Europe, and Latin America Fully DEA-licensed Schedule I–V manufacturing for compounds including psilocybin, LSD, DMT, and additional emerging CNS therapeutics Comprehensive commercialization support to accelerate the safe, compliant delivery of new medicines to patients Accelerating Innovation in Psychedelics, Cannabinoids, and Novel Therapeutics As research into psychedelic and cannabinoid-based CNS treatments accelerates—addressing conditions such as depression, PTSD, and substance-use disorders—demand for reliable, compliant, and highly specialized infrastructure continues to rise. This strategic partnership positions Benuvia and CCRP at the forefront of a market that is expanding globally and evolving rapidly in both scientific and regulatory complexity. "This collaboration underscores our shared mission to improve global healthcare through the responsible development and commercialization of controlled-substance therapeutics," added Lisa Rich-Milan, CEO of CCRP. "By uniting manufacturing, regulatory, and clinical operations within a single coordinated platform, we will be able to offer sponsors a responsible, efficient, and globally accessible pathway for advancing next-generation medicines." About Benuvia Operations, LLC Benuvia Operations, LLC is a U.S.-based global Contract Development and Manufacturing Organization (CDMO) and Active Pharmaceutical Ingredient (API) supplier servicing pharmaceutical and biotech companies. The company provides development and manufacturing services for small-molecule APIs and finished dosage products with extensive experience with cannabinoids, psychedelics, and other controlled substances. Benuvia operates an 83,000 square foot best-in-class manufacturing facility in Round Rock, Texas that can safely and securely handle Schedule I-V controlled substances products, offering comprehensive solutions for companies throughout the entire drug development lifecycle - from API synthesis, clinical trial supply, through commercial production. Learn more at . Forward Looking Statements This press release may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words "anticipate', "believe", "could", "estimate", "upcoming", "expect", "intend", "may", "plan", "redirect", "project", "will", and similar terms and phrases may be used to identify forward-looking statements in this press release. Our operations involve risks and uncertainties many of which are outside our control and any one of which, or a combination of which, could materially affect our results of operations and whether the forward-looking statements should be considered together with the risks and uncertainties discussed in our filings with the Securities and Exchange Commission at . These forward-looking statements are based on information are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law. Contacts For Benuvia Operations, LLC: Arijan Limani, Business Development [email protected] (319) 444-0090 For CCRP: Lisa Rich-Milan, CEO [email protected] (678) 310-8284 SOURCE Benuvia Operations, LLC 21% more press release views with Request a Demo

2025年12月3日，石药集团（01093.HK）宣布，其开发的化药1类新药SYH2056片已获得美国食品药品监督管理局（FDA）批准开展临床试验；而就在11月，该药物已率先获得中国国家药品监督管理局批准在中国开展临床试验，两项获批的临床适应症均为抑郁症。作为石药集团从"me-better"向"best-in-class"转型的关键产品，SYH2056片的获批不仅标志着中国创新药在抗抑郁领域的突破，更有望为中国超9500万抑郁症患者（其中30%对现有药物无响应）带来新的治疗选择。 1. 中美双报临床获批，瞄准抑郁治疗"未满足需求" SYH2056片的中美同步临床推进，是石药集团全球化布局的重要一步。根据公告，该药物为化药1类新药，针对的是抑郁障碍这一高发疾病——中国抑郁症患者超9500万人，但现有药物存在起效慢（通常需2-4周）、疗效不稳定、副作用大等问题，30%患者对传统治疗无响应。此次中美双批，将进一步验证其在人体中的安全性与有效性，为后续上市奠定基础。 2. 创新机制破局：快速起效与神经重塑的双重优势 作为选择性5-HT2A受体激动剂，SYH2056片的核心优势在于"快速起效"与"神经重塑"的结合。传统抗抑郁药通常需要2-4周才能见效，而SYH2056片单次给药即可快速缓解抑郁症状，且药效持久。更关键的是，其作用机制并非停留在"症状缓解"——临床前研究显示，该药物可有效促进中枢神经元的树突与树突棘生成，通过神经重塑从根本上改善抑郁障碍的神经病理基础。在多种抑郁动物模型中，SYH2056片表现出优异的抗抑郁活性，且未出现传统5-HT2A受体激动剂（如裸盖菇素）常见的致幻风险。 3. 从"致幻风险"到"安全窗口"：技术优化的关键突破 传统5-HT2A受体激动剂因致幻副作用限制了临床应用，SYH2056片通过结构优化显著降低了这一风险，同时保持了良好的药代动力学特性与安全性，治疗窗口更宽。此外，石药集团已在国内外提交多项核心专利申请，覆盖化合物结构、适应症及制剂方案，为其"best-in-class"定位构建了技术壁垒。这种从"跟随"到"引领"的转变，标志着石药集团在创新药研发上的战略升级——不再满足于"me-better"，而是瞄准"同类最优"目标。 4. 市场潜力：医保预期与适应症拓展的想象空间 SYH2056片的市场前景基于对"未满足需求"的精准覆盖。作为国产1类新药，它有望纳入医保，预计年治疗费用较进口药低20%-30%，提升患者可及性。此外，5-HT2A受体靶点在焦虑症、创伤后应激障碍（PTSD）等领域也有应用潜力，未来可拓展适应症。据测算，中国抗抑郁药市场年增速超15%，2025年规模预计突破200亿元，若SYH2056片占据10%份额，年销售额可达20亿元；若临床试验顺利，2030年前后上市后峰值销售额或超30亿元。