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VANCOUVER, BC / ACCESSWIRE / December 11, 2023 / Wex Pharmaceuticals Inc. ("WEX" or the "Company"), a biotechnology company developing Halneuron® (Tetrodotoxin or TTX) for pain, announced that it has commenced its Quantitative Sensory Testing (QST) clinical trial and is actively recruiting participants into this clinical trial. The QST clinical trial is being conducted in the Netherlands on 25 healthy volunteers, where each volunteer will receive two different doses of Halneuron. The primary objective is to evaluate the effect on the peripheral nervous system when different doses of TTX are administered to healthy volunteers. Sensitivity and pain from cold, heat, touch, vibration, and smell will be assessed. Mr. Walter Korz, Chief Executive Officer of WEX says, "Quantifying the impact of TTX on a healthy person's sensory perceptions will help us further understand how and why TTX uniquely relieves pain differently from common pain therapies used today. The QST clinical trial will also help us to better understand how TTX can be used in a more personalized manner to enhance its effectiveness for pain management." This is the first time Halneuron® will be evaluated in Europe. WEX has received EMA approval to conduct this clinical trial including obtaining necessary permits to import Halneuron into Europe. About Quantitative Sensory Testing (QST) QST is a sensitive, validated measure for peripheral sensory nervous function. The QST clinical trial involves stimulating a person's skin with quantified sensory stimuli to determine thresholds and other changes in their sensory perception and sensory function. Heat and cold responses provide information about the function of thinly myelinated Aδ nerve fibers, light touch and vibration responses provide information about large myelinated Aβ nerve fibers, and a pain response indicates an impact on unmyelinated C fibers. About Halneuron® Halneuron® (TTX, Tetrodotoxin), a selective sodium channel blocker, produces analgesia either by decreasing the propagation of action potentials by sodium channels and/or by blocking ectopic discharges associated with chronic pain. Halneuron® is an injectable formulation of Tetrodotoxin, a novel small molecule with action exclusively on the peripheral nervous system. Halneuron does not cross the blood-brain barrier and, therefore, is without the common side effects of euphoria, addiction, tolerance, sedation, and confusion experienced by opioids and other analgesics. Pharmacology studies revealed that TTX is a more potent analgesic than standard analgesic agents such as aspirin, morphine, or meperidine, with potential applications in many moderate to severe neuropathic pain conditions. About WEX Pharmaceuticals Inc. WEX Pharmaceuticals Inc. is a late-stage drug development company dedicated to the development, manufacture, and commercialization of innovative drug products to treat pain. WEX is a leader in research in the field of sodium channel blockers and has programs in various stages of development based on the Halneuron® platform. WEX has conducted late-stage multinational clinical trials in cancer pain and chemotherapy-induced neuropathic pain. WEX is a wholly owned subsidiary of CK Life Sciences Int'l., (Holdings) Inc. ("CKLS"). CKLS is engaged in the business of research and development, manufacturing, commercialization, marketing, sale of, and investment in products and assets which fall into three core categories - nutraceuticals, pharmaceuticals & diagnostics, and agriculture-related. CKLS is a member of the CK Hutchison Group. For additional information, please visit . This news release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and forward-looking information under applicable Canadian securities laws (collectively "forward-looking statements"), including statements regarding the safety and therapeutic utility of Halneuron® as a peripheral-acting, non-opioid analgesic. Statements in this document regarding future expectations, beliefs, goals, plans, or prospects constitute forward-looking statements that involve risks and uncertainties, which may cause actual results to differ materially from the statements made. For this purpose, any statements that are contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "projects", "reduces," "affirms", "acceptable", "accepts", "establishes", "continued advancement", and similar expressions are intended to identify forward-looking statements. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause actual results, future circumstances, or events to differ materially from those projected in the forward-looking statements. These risks include, but are not limited to: those associated with the success of research and development programs, the Company's ability to raise additional funding and the potential dilutive effects thereof, the regulatory approval process, competition, securing and maintaining corporate alliances, market acceptance of the Company's products, the availability of government and insurance reimbursements for the Company's products, the strength of intellectual property, reliance on subcontractors and key personnel and other risks detailed from time-to-time in the Company's public disclosure documents and other filings with the U.S. Securities and Exchange Commission and Canadian securities regulatory authorities. Forward-looking statements are developed based on assumptions about such risks, uncertainties and other factors, including, but not limited to: obtaining positive results of clinical trials, obtaining regulatory approvals, TTX is a more potent analgesic than standard analgesics, safety of product, effectiveness of drug, general business and economic conditions, the Company's ability to successfully develop and commercialize new products, the assumption that the Company's current good relationships with third parties will be maintained, the availability of financing on reasonable terms, the Company's ability to attract and retain skilled staff, market competition, the products and technology offered by the Company's competitors, no known competing drugs specifically for CINP, and the Company's ability to protect patents and proprietary rights. Forward-looking statements are made as of the date hereof, and the Company disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. For further information contact: WEX Pharmaceuticals Inc. Mr. Walter Korz Chief Executive Officer Phone: (604) 683-8880 Fax: (604) 683-8868 E-mail: wex@wexpharma.com Internet: SOURCE: WEX Pharmaceuticals Inc. View the original press release on accesswire.com

来源：青海药监局     整理：wangxinglai2004近日，青海药监局发布了两则行政处罚通知，两药企在有因检查、专项检查过程中被发现生产质量管理体系严重偏离GMP，检查结论为不符合要求、被处罚。1、青海制药有限公司青海制药有限公司其前身青海制药厂始建于1958年5月，于2000年更名为青海制药有限公司，是国家麻醉药品生产基地、生产范围包括麻醉药品和精神药品，拥有化学原料药及制剂相关生产线，本次在国家局组织的有因检查过程中，发现生产质量管理体系严重偏离GMP要求，不符合要求，被处罚。行政处罚文书号：青药监罚〔2023〕3号案件名称：青海制药有限公司严重违反药品生产质量管理规范案违法企业名称:青海制药有限公司主要违法事实：国家药监局组织的有因检查中，认为其生产质量管理体系严重偏离GMP要求，综合评定结论为不符合要求。违反了《中华人民共和国药品管理法》（2019年修订）第四十三条规定。行政处罚的种类和依据：依据《中华人民共和国药品管理法》（2019年修订）第一百二十六条规定，处以罚款。编语第一百二十六条 除本法另有规定的情形外，药品上市许可持有人、药品生产企业、药品经营企业、药物非临床安全性评价研究机构、药物临床试验机构等未遵守药品生产质量管理规范、药品经营质量管理规范、药物非临床研究质量管理规范、药物临床试验质量管理规范等的，责令限期改正，给予警告；逾期不改正的，处十万元以上五十万元以下的罚款；情节严重的，处五十万元以上二百万元以下的罚款，责令停产停业整顿直至吊销药品批准证明文件、药品生产许可证、药品经营许可证等，药物非临床安全性评价研究机构、药物临床试验机构等五年内不得开展药物非临床安全性评价研究、药物临床试验，对法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入百分之十以上百分之五十以下的罚款，十年直至终身禁止从事药品生产经营等活动。对照法条，因为说的是严重偏离所以一定是情节严重的情况，到底本次检查发现有多严重偏离GMP，恐怕只能自行脑补了；虽然处罚只说了罚款，但是小编猜测停产整顿是在所难免的，尤其是生产麻醉和精神药品的企业，至于相关从业人员是否有罚金不得而知，但是对比过往企业处罚案例，恐怕该企业主要负责人也是难逃法网；对于药企的同仁们只能说从业风险警钟长鸣与君共勉，过往案例整理如下：1、辽宁省2022年9月5日辽宁省药监局发布1则行政处罚通知，辽宁可济药业有限公司未遵守药品生产质量管理规范，被处于125万元罚款，责令停产停业整顿1个月，同时该公司生产、质量负责人也被处罚。没收企业生产负责人张某3918.22元，并处罚款1175.47元，罚没款合计5093.69元；没收企业质量负责人兼质量受权人任某波3556.4元，并处罚款1066.92元，罚没款合计4623.32元。2、四川药监局2022年08月12日，四川药监局发布了1则行政处罚通知，成都芝芝药业有限公司及该司生产负责人李贵权因严重违反《药品生产质量管理规范》分别受到处罚，其中生产负责人被处以10禁业及罚金。没收李贵权违法行为发生期间自本公司所获收入195823元，并处所获收入22%的罚款43081元；禁止李贵权10年内从事药品生产经营活动。3、云南药监局2021年06月25日，云南药监局发布了1则行政处罚通知，云南龙发制药股份有限公司违反GMP改变生产工艺、编造生产记录生产被罚款2017.57567万元；停产停业整顿；主要负责人禁止十年内从事药品生产经营等活动。公司负责人、生产负责人罚款、禁止十年内从事药品生产经营等活动。没收个人违法所得、罚款企业生产地址和生产范围（正本）：青海省西宁市城北区祁连路469号：小容量注射剂，口服溶液剂，原料药，片剂，糖浆剂，麻醉药品，精神药品***生产地址和生产范围（副本）：青海省西宁市城北区祁连路469号：小容量注射剂，口服溶液剂，原料药(盐酸丁丙诺啡、硫酸吗啡、那可丁、盐酸可卡因、盐酸吗啡、阿片粉、盐酸乙基吗啡、盐酸罂粟碱、盐酸哌替啶、盐酸阿扑吗啡、磷酸可待因、氢溴酸烯丙吗啡、乳酸依沙吖啶、酒石酸双氢可待因、盐酸纳洛酮、盐酸美沙酮、盐酸甲氧那明(仅限注册文号申报))，片剂，糖浆剂，麻醉药品，精神药品***2、青海瑞成药业（集团）有限公司青海瑞成药业（集团）有限公司是一家中药制剂生产企业，在本次青海省药监局组织的专项检查过程中，发现生产质量管理体系严重偏离GMP要求，不符合要求，被处罚。行政处罚文书号：青药监罚〔2023〕4号案件名称：青海瑞成药业（集团）有限公司严重违反药品生产质量管理规范案违法企业名称:青海瑞成药业（集团）有限公司主要违法事实：青海省药监局在专项检查中，认为其生产质量管理体系严重偏离GMP要求，综合评定为不符合要求。违反了《中华人民共和国药品管理法》（2019年修订）第四十三条规定。行政处罚的种类和依据：依据《中华人民共和国药品管理法》（2019年修订）第一百二十六条规定，处以罚款。编语第一百二十六条 除本法另有规定的情形外，药品上市许可持有人、药品生产企业、药品经营企业、药物非临床安全性评价研究机构、药物临床试验机构等未遵守药品生产质量管理规范、药品经营质量管理规范、药物非临床研究质量管理规范、药物临床试验质量管理规范等的，责令限期改正，给予警告；逾期不改正的，处十万元以上五十万元以下的罚款；情节严重的，处五十万元以上二百万元以下的罚款，责令停产停业整顿直至吊销药品批准证明文件、药品生产许可证、药品经营许可证等，药物非临床安全性评价研究机构、药物临床试验机构等五年内不得开展药物非临床安全性评价研究、药物临床试验，对法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入百分之十以上百分之五十以下的罚款，十年直至终身禁止从事药品生产经营等活动。对照法条，因为说的是严重偏离所以一定是情节严重的情况，虽然说GMP是否适用于中药行业业界一直存在争议、中药企业的GMP管理在制药行业中属于最底层也是普遍现象，但这并不是违法违规的理由；尤其是出现了严重偏离，这只能说明企业主观存在违法违规的强烈意愿，对也中药行业从业人员来说还是要警醒灰色边缘和底线的区别，以免引火烧身出现从业人员被处罚案例。企业生产地址和生产范围（正本）：西宁市经济技术开发区东新路18号：硬胶囊剂，洗剂***生产地址和生产范围（副本）：西宁市经济技术开发区东新路18号：硬胶囊剂，洗剂(灌肠液)***