Gastrointestinal ulcer

Recently, ZBD Pharmaceutical made a breakthrough in the field of traditional Chinese medicine innovation, and its self-developed 1.1 new drug - Qingdown and Wei Granules successfully approved to enter the clinical trial stage. In China, chronic diseases of the digestive tract, especially gastric ulcer, gastroesophageal reflux and other chronic diseases, have long posed a major challenge to public health, and the value of the gastric medicine market, especially the Zhongcheng gastric medicine market, is gradually widely recognized and valued by the industry. The vigorous development of China's stomach medicine market cannot be separated from the huge patient base as support. According to the 2019 China Gastropathy Survey Report, among the 1.3 billion population at that time, the number of patients with gastropathy has reached 120 million, of which the elderly account for more than 70%. The incidence of gastrointestinal ulcer has reached 10%, and the incidence of chronic gastritis has climbed to 30%, which all indicate the severity of stomach problems. Further investigation found that based on 22,152 valid sample statistics, mainly young and middle-aged people, up to 65.55% of the respondents clearly said that they suffer from stomach problems, another 22.18% of the patients have a vague attitude toward their illness, and only 12.27% of the people confidently said that they are not affected by stomach problems. The results of this survey undoubtedly provide a strong demand support for the continued growth of the stomach medicine market. In recent years, the scale of China's stomach medicine market continues to expand, especially the market performance of Chinese patent medicine stomach medicine (for gastritis, ulcer and other diseases) is particularly eye-catching. According to statistics, between 2021 and 2022, the total market size of Chinese patent medicine stomach medicine in China's three major terminal markets has exceeded 10.4 billion yuan. Among them, the sales of Chinese patent medicine stomach medicine in urban physical pharmacies exceeded 2.7 billion yuan, an increase of 2.46%; The online pharmacy terminal sales of proprietary Chinese medicine stomach medicine soared to 440 million yuan, a year-on-year growth rate of 70.04%, showing a strong growth momentum. In the fierce market competition, some brands stand out with their excellent product quality and marketing strategies. For example, in China's public medical institutions terminal Chinese patent medicine stomach medicine market in 2023, there are three brands with sales of more than 500 million yuan. They are Good Doctor Group's rehabilitation new liquid (sales of more than 700 million yuan), Yangzijiang's Weisu Granule (sales of more than 600 million yuan) and Kelun Pharmaceutical's rehabilitation new liquid (sales of more than 600 million yuan). The success of these brands not only reflects their deep strength in product development, marketing and other aspects, but also sets a benchmark for the entire stomach medicine market. From the perspective of sales channels, the sales of proprietary Chinese medicine stomach medicine are mainly divided into online and offline two major sectors. In the online field, with the rise of e-commerce platforms and the change of consumer shopping habits, the online market of stomach medicine has formed a considerable scale and is in a stage of steady expansion. In terms of physical stores, some brands have achieved rapid growth through continuous innovation and optimization of product mix, improving service quality and other means. For example, among the Top 20 brands in physical stores, the fast stomach tablet of Qingdao Guofeng Pharmaceutical Industry, owned by Shanghai Pharmaceutical, performed particularly well, with a year-on-year growth rate of 179.34% in the first half of 2023. In addition, Li Wanshan Pharmaceutical Co., Ltd. also achieved more than 100% growth in Hewei Chengchang pills, with total sales among the top three. It is worth mentioning that in recent years, the rapid development of online pharmacies has injected new vitality into the Chinese patent medicine stomach medicine market. According to statistics, the compound annual growth rate (CAGR) of drug sales in online pharmacies between 2014 and 2021 has reached a staggering 50.54%. In 2021, the sales of drugs in online pharmacies have reached 36.8 billion yuan, an increase of 51.5% year-on-year, of which the growth of OTC drugs is mainly driven by proprietary Chinese medicines. In particular, among the three newly listed top20 online sales drugs in online pharmacies, Yunnan Plant Pharmaceutical's Hawthorn and Poria granules, Ark Pharm's Yangweishu tablets and Yunnan Baoyuantang Pharmaceutical The year-on-year growth rate of Weikang capsules and other products of Industry has exceeded thousands, showing strong growth potential. Looking forward to the future with the continuous improvement of people's health awareness and the continuous progress of medical science and technology, the market of proprietary Chinese medicine stomach medicine will usher in a broader space for development. On the one hand, existing brands will continue to increase research and development investment to promote product upgrading to meet the increasingly diverse needs of patients; On the other hand, emerging brands will continue to emerge to seize market share through differentiated competitive strategies. At the same time, with the further popularization of the Internet and the continuous innovation of online sales model, the online sales share of the Chinese patent medicine stomach medicine market is also expected to continue to grow, bringing more opportunities and challenges to the entire industry. In this process, ZBD Pharmaceutical's Qingxin and Wei granules are undoubtedly a bright new star. The innovative drug Qingjiang and Weiwei Granules, developed by ZBD Pharmaceutical in collaboration with Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, has demonstrated good safety and efficacy in the preclinical research phase. The drug is mainly used in the treatment of non-erosive gastroesophageal reflux disease (NERD) cold and heat syndrome, filling the gap in the field of proprietary Chinese medicine. According to relevant data, it is estimated that the number of NERD patients in China has exceeded 40 million, which means that Qingjiang and Wei granules have huge market potential. In the future, with the smooth promotion of clinical trials and the gradual development of market promotion of the drug, Qingjianghewei Granule is expected to become a dark horse in the market of patent Chinese medicine stomach medicine, injecting new impetus into the development of ZBD Pharmaceutical and the entire industry.

来源：国家药监局  编辑：wangxinglai2004 2024年07月02日，国家药监局发布公告，根据药品不良反应评估结果，为进一步保障公众用药安全，国家药品监督管理局决定对复方感冒灵制剂说明书和银黄口服制剂说明书内容进行统一修订，要求企业于2024年9月27日前报国家药品监督管理局药品审评中心或省级药品监督管理部门备案。   通知原文 根据药品不良反应评估结果，为进一步保障公众用药安全，国家药品监督管理局决定对复方感冒灵制剂说明书和银黄口服制剂说明书中的【警示语】、【不良反应】、【禁忌】和【注意事项】进行统一修订。现将有关事项公告如下：   一、所有上述药品的上市许可持有人应当依据《药品注册管理办法》等有关规定，按照要求修订说明书（见附件），于2024年9月27日前报省级药品监督管理部门备案。   修订内容涉及药品标签的，应当一并进行修订；说明书及标签其他内容应当与原批准内容一致。在备案之日起生产的药品，不得继续使用原药品说明书。药品上市许可持有人应当在备案后9个月内对已出厂的药品说明书及标签予以更换。   二、药品上市许可持有人应当对新增不良反应发生机制开展深入研究，采取有效措施做好药品使用和安全性问题的宣传培训，指导医师、药师或患者合理用药。   三、临床医师、药师应当仔细阅读上述药品说明书的修订内容，在选择用药时，应当根据新修订说明书进行充分的获益/风险分析。   四、患者用药前应当仔细阅读药品说明书，使用处方药的，应当严格遵医嘱用药。   五、省级药品监督管理部门应当督促行政区域内上述药品的上市许可持有人按要求做好相应说明书修订和标签、说明书更换工作，对违法违规行为依法严厉查处。 说明书修订要求 复方感冒灵制剂非处方药说明书修订要求   一、【警示语】项修改为：   1.本品含对乙酰氨基酚、马来酸氯苯那敏、咖啡因。   2.服用本品期间不得饮酒或含有酒精的饮料；不能同时服用与本品成份相似的其他抗感冒药；服药期间不得驾驶机、车、船、从事高空作业、机械作业及操作精密仪器。   3.与其他解热镇痛药并用有增加肾毒性的危险。   二、【禁忌】项应包括：   1.严重肝肾功能不全者禁用。   2.对本品及所含成份过敏者禁用。   三、【不良反应】项应增加：   监测数据显示，复方感冒灵制剂可见以下不良反应报告：   各类神经系统疾病：嗜睡、困倦、头晕、头痛等。   皮肤及皮下组织类疾病：皮疹、瘙痒、潮红、剥脱性皮炎、大疱性表皮松解症等。   全身性疾病及给药部位各种反应：乏力、虚弱、胸部不适、发热等。   胃肠系统疾病：恶心、呕吐、口干、腹泻、腹痛、腹胀、腹部不适等。   肝胆系统疾病：肝功能异常、肝损伤、肝生化指标异常等。长期大量用药会导致肝功能异常；过量使用对乙酰氨基酚可引起严重肝损伤。   肾脏及泌尿系统：排尿困难、尿频、尿潴留、血尿症、急性肾损伤等。长期大量用药会导致肾功能异常。   其他：心悸、呼吸困难、白细胞减少、溶血性贫血、中性粒细胞减少、过敏反应、过敏性休克等。   四、【注意事项】项应包括：   1.忌烟、酒及辛辣、生冷、油腻食物。   2.不宜在服药期间同时服用滋补性中药。   3.脾胃虚寒者慎用。   4.风寒感冒者不适用，其表现为恶寒重、发热轻、无汗、鼻塞、流清涕、喉痒咳嗽等。   5.当出现皮疹或过敏反应的其他征象时，如用药后出现瘙痒、皮疹，尤其出现口腔、眼、外生殖器红斑、糜烂等，应当立即停药并就医。   6.因过量使用对乙酰氨基酚有引起严重肝损伤的报道。用药期间如发现肝生化指标异常或出现全身乏力、食欲不振、厌油、恶心、上腹胀痛、尿黄、目黄、皮肤黄染等可能与肝损伤有关的临床表现时，应当立即停药并就医。建议对乙酰氨基酚口服一日最大量不超过2克。   7.本品含对乙酰氨基酚、马来酸氯苯那敏、咖啡因。服用本品期间不得饮酒或含有酒精的饮料；不能同时服用与本品成份相似的其他抗感冒药；服药期间不得驾驶机、车、船、从事高空作业、机械作业及操作精密仪器。   8.肝、肾功能不全者慎用，上消化道溃疡、膀胱颈梗阻、甲状腺功能亢进、青光眼、高血压和前列腺肥大者慎用，孕妇及哺乳期妇女慎用，且应当在医生指导下服用。   9.运动员慎用。   10.心脏病、肝病、糖尿病、肾病等患者应当在医师指导下服用。   11.严格按用法用量服用，儿童、年老体弱者应当在医师指导下服用。   12.服药2天症状无缓解，应当去医院就诊。   13.过敏体质者慎用。   14.本品性状发生改变时禁止使用。   15.儿童必须在成人监护下使用。   16.请将本品放在儿童不能接触的地方。   17.如正在使用其他药品，使用本品前请咨询医师或者药师。   （注：如原批准说明书的安全性内容较本修订要求内容更全面或更严格的，应当保留原批准内容。说明书其他内容如与上述修订要求不一致的，应当一并进行修订。）   复方感冒灵制剂处方药说明书修订要求   一、【警示语】项修改为：   1.本品含对乙酰氨基酚、马来酸氯苯那敏、咖啡因。   2.服用本品期间不得饮酒或含有酒精的饮料；不能同时服用与本品成份相似的其他抗感冒药；服药期间不得驾驶机、车、船、从事高空作业、机械作业及操作精密仪器。   3.与其他解热镇痛药并用有增加肾毒性的危险。   二、【禁忌】项应包括：   1.严重肝肾功能不全者禁用。   2.对本品及所含成份过敏者禁用。   三、【不良反应】项应增加：   监测数据显示，复方感冒灵制剂可见以下不良反应报告：   各类神经系统疾病：嗜睡、困倦、头晕、头痛等。   皮肤及皮下组织类疾病：皮疹、瘙痒、潮红、剥脱性皮炎、大疱性表皮松解症等。   全身性疾病及给药部位各种反应：乏力、虚弱、胸部不适、发热等。   胃肠系统疾病：恶心、呕吐、口干、腹泻、腹痛、腹胀、腹部不适等。   肝胆系统疾病：肝功能异常、肝损伤、肝生化指标异常等。长期大量用药会导致肝功能异常；过量使用对乙酰氨基酚可引起严重肝损伤。   肾脏及泌尿系统：排尿困难、尿频、尿潴留、血尿症、急性肾损伤等。长期大量用药会导致肾功能异常。   其他：心悸、呼吸困难、白细胞减少、溶血性贫血、中性粒细胞减少、过敏反应、过敏性休克等。   四、【注意事项】项应包括：   1.忌烟、酒及辛辣、生冷、油腻食物。   2.不宜在服药期间同时服用滋补性中药。   3.脾胃虚寒者慎用。   4.风寒感冒者不适用，其表现为恶寒重、发热轻、无汗、鼻塞、流清涕、喉痒咳嗽等。   5.当出现皮疹或过敏反应的其他征象时，如用药后出现瘙痒、皮疹，尤其出现口腔、眼、外生殖器红斑、糜烂等，应当立即停药并咨询医生。   6.因过量使用对乙酰氨基酚有引起严重肝损伤的报道。用药期间如发现肝生化指标异常或出现全身乏力、食欲不振、厌油、恶心、上腹胀痛、尿黄、目黄、皮肤黄染等可能与肝损伤有关的临床表现时，应当立即停药并就医。建议对乙酰氨基酚口服一日最大量不超过2克。   7.本品含对乙酰氨基酚、马来酸氯苯那敏、咖啡因。服用本品期间不得饮酒或含有酒精的饮料；不能同时服用与本品成份相似的其他抗感冒药；服药期间不得驾驶机、车、船、从事高空作业、机械作业及操作精密仪器。   8.应尽量避免合并使用其他解热镇痛药的药品，以避免药物过量或导致毒性协同作用。   9.肝、肾功能不全者慎用；上消化道溃疡、膀胱颈梗阻、甲状腺功能亢进、青光眼、高血压和前列腺肥大者慎用；孕妇及哺乳期妇女慎用。   10.过敏体质者慎用。   （注：如原批准说明书的安全性内容较本修订建议内容更全面或更严格的，应当保留原批准内容。说明书其他内容如与上述修订要求不一致的，应当一并进行修订。)   银黄口服制剂说明书修订要求   1.银黄颗粒（胶囊、滴丸、软胶囊、片、丸、分散片、咀嚼片）非处方药说明书修订要求   一、【不良反应】项应当包括：   监测数据显示，本品可见以下不良反应报告：腹泻、腹痛、腹部不适、腹胀、恶心、呕吐、口干、口苦、皮疹、瘙痒、红斑、荨麻疹、头晕、头痛、乏力、胸部不适、心悸、潮红、过敏反应等，有严重过敏反应个案报告。   二、【禁忌】项应当包括：   对本品及所含成份过敏者禁用。   三、【注意事项】项应当包括：   1.忌烟酒、辛辣、鱼腥食物。   2.不宜在服药期间同时服用温补性中成药。   3.脾胃虚寒症见有大便溏者慎用，且应当在医师指导下服用。   4.本品含蔗糖，糖尿病患者慎用。*   5.高血压、心脏病、肝病、糖尿病、肾病等患者应当在医师指导下服用。   6.按照本品说明书用法用量服用。儿童、孕妇、哺乳期妇女、年老体弱者应当在医师指导下服用。   7.扁桃体有化脓或者发热体温超过38.5℃的患者应当去医院就诊。   8.服药3天症状无缓解，或者症状加重，或者出现新的症状，应当去医院就诊。   9.过敏体质者慎用。   10.本品性状发生改变时禁止使用。   11.儿童必须在成人的监护下使用。   12.请将本品放在儿童不能接触的地方。   13.如正在使用其他药品，使用本品前请咨询医师或者药师。   （注：1.*限于银黄颗粒含蔗糖的剂型。2.如原批准说明书的安全性内容较本修订要求内容更全面或者更严格的，应当保留原批准内容，说明书其他内容如与上述修订要求不一致的，应当一并进行修订。3.如原批准说明书【注意事项】无“儿童应在医师指导下服用”“儿童必须在成人的监护下使用”，不增加相应内容。）

TORONTO--(BUSINESS WIRE)-- Antibe Therapeutics Inc. (“Antibe” or the “Company”) (TSX: ATE) announced that the Company sought an extension of its previously announced stay of proceedings (“Stay”) under the Companies’ Creditors Arrangement Act (the “CCAA”) at a hearing before the Ontario Superior Court of Justice (Commercial List) (the “Court”) on April 18, 2024. The Court has reserved its decision and extended the Stay pending release of the decision. The Company is requesting to extend the Stay until May 24, 2024 in order to be able to continue engaging with the U.S. Food and Drug Administration with respect to the previously announced hold on the Company’s planned Phase II trial and to determine appropriate next steps. About Antibe Therapeutics Inc. Antibe is a clinical-stage biotechnology company leveraging its proprietary hydrogen sulfide platform to develop next-generation therapies to target pain and inflammation arising from a wide range of medical conditions. The Company’s current pipeline includes assets that seek to overcome the gastrointestinal ulcers and bleeding associated with nonsteroidal anti-inflammatory drugs (“NSAIDs”). Antibe’s lead drug, otenaproxesul, is intended as a safer alternative to opioids and today’s NSAIDs for acute pain. Antibe’s second pipeline drug, ATB-352, is being developed for a specialized pain indication. The Company’s next target is inflammatory bowel disease (“IBD”), a condition long in need of safer, more effective therapies. Learn more at antibethera.com. Forward Looking Statements This news release includes certain forward-looking statements under applicable securities laws, which may include, but are not limited to, statements concerning the extension of the Stay, payment of amounts due to Nuance under the arbitral award, anticipated engagement with the U.S. Food and Drug Administration concerning the clinical hold on otenaproxesul. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “will”, “anticipate”, “believe”, “plan”, “estimate”, “expect”, “intend”, “propose” and similar wording. Forward-looking statements involve known and unknown risks and uncertainties that could cause actual results, performance, or achievements to differ materially from those expressed or implied in this news release. Factors that could cause actual results to differ materially from those anticipated in this news release include, but are not limited to, the decision of the Court with respect to the extension of the Stay and any subsequent determinations made by the Court, the Company’s inability to timely execute on its business strategy and timely and successfully complete its clinical trials and studies, the Company’s inability to obtain the necessary regulatory approvals related to its activities, risks associated with drug development generally and those risk factors set forth in the Company’s public filings made in Canada and available on sedarplus.com. The Company assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those reflected in the forward-looking statements except as required by applicable law.