26 10 月, 2022

中国的临床研究机会和美国食品药品监督管理局批准的途径 – 白皮书

SYDNEY, AU, Oct 26, 2022 - (亚太商讯 via SEAPRWire.com) - Novotech、亚太地区领先的生物技术专家合同研究机构和GlobalData发布了最新的中国生物技术前景分析，并就美国 FDA 批准在中国开展研究的生物技术的途径提供专家指导。点击这里下载白皮书 https://novotech-cro.com/whitepapers/china-biotech-landscape-opportunities-china-and-path-usfda-approval该报告是为考虑在中国进行临床研究的国际生物技术公司以及在中国进行研究的中国生物技术公司以及美国FDA批准所需的相关流程编写的。Novotech 副总裁、临床服务全球负责人 Yooni Kim 博士说：“中国拥有庞大的人口和世界级的研究设施和 KOL，提供了非凡的临床机会。这份对美国FDA批准途径的简明分析专业地告知临床阶段的生物技术公司有关中国研究的好处以及如何应对任何挑战。该报告详细介绍了生物技术的监管要求，包括NDA和IND流程，以及成功获得USFDA批准途径的美国前研究指南。Novotech 在中国和美国拥有经验丰富的临床团队，可以提供相关的监管知识和药物开发途径，专门为支持美国 FDA 的审批流程而设计，避免延误和额外成本。”该报告的主要收获是：- 公司应尽早与美国食品和药物管理局正式接触，以确认其临床路线图的指导。- 中国的临床开发法规与美国食品药品监督管理局的法规一致，为生物制药公司带来了巨大的利益。- 生物制药公司应利用中国修订后的监管框架，即接受外国临床试验数据进行药物审批，使外国公司更容易进入中国市场。- 对于希望进入中国的生物制药公司而言，中国医药市场具有开展首次人体试验（FIH）和利用海外临床试验数据进行临床试验申请（CTA）备案、利用快速临床开发途径加快审批等优势。过程;上市许可持有人 (MAH) 制度的实施、促进国内和全球创新的有利政府政策鼓励外国直接投资 (FDI) 进行研发，使海外公司受益。- 中国生物技术公司可以通过战略合作或在这些市场建立自己的业务，进入美国和欧洲的发达市场。Novotech 在亚太地区和美国拥有丰富的临床研究机构运营经验，为早期至晚期生物技术临床研究提供独特且无与伦比的服务套件。Novotech 拥有数十年的生物技术药物开发经验、卓越的研究中心和研究人员关系、接触大量患者群体以及专注于解决问题、所有权和灵活性的项目管理方法。对高级培训和技术系统的持续投资相结合，提供专业的全方位服务生物技术临床研究机构解决方案。Novotech 最近被评为世界领先合同研究组织中的前十名合同研究组织，是著名的 Scrip 奖的决赛入围者，并且刚刚获得了基因与细胞治疗卓越奖。在亚太地区，Novotech 与主要医学研究机构签订了 50 多项领先的合作伙伴协议，为赞助商提供独家优惠。关于Novotech健康控股Novotech健康控股有限公司（“Novotech”）是亚太地区及美国领先的生物技术专家 CRO。 Novotech 是一家 CRO，拥有综合实验室和 I 期设施，提供药物开发咨询和临床开发服务。它有助于在所有试验阶段和广泛的治疗领域成功进行大约 4,000 项临床试验。Novotech具有明显优势，可以为在亚洲及美国进行临床试验的生物制药客户提供服务。详细信息请访问 https://novotech-cro.com/contact 媒体联系人David JamesE: communications@novotech-cro.com 澳大利亚: +61 2 8218 2144美国: +1 415 951 3228亚洲: +65 3159 3427 Copyright 2022 亚太商讯. All rights reserved. (via SEAPRWire)

17 10 月, 2022

生物技术领域网络研讨会：市场趋势、优先事项、预测和 FDA 批准途径

SYDNEY, AU, Oct 17, 2022 - (亚太商讯 via SEAPRWire.com) - Novotech 是亚太地区领先的生物技术专家合同研究机构和 Endpoints News 为生物技术公司举办的网络研讨会，涵盖了亚太地区的临床研究机会和获得 FDA 批准的监管途径。Novotech 在亚太地区和美国拥有丰富的临床研究机构运营经验，为早期至晚期生物技术临床研究提供独特且无与伦比的服务套件。该网络研讨会邀请了来自北美和亚太地区的监管事务和投资领导人，他们将讨论：- 为什么生物技术公司越来越多地在亚太地区探索临床机会以生成多样化、全球认可的临床试验数据- 可以实施哪些可行的策略来利用亚太地区的招聘潜力来加速您的临床开发- 来自澳大利亚的 1 期数据如何被 FDA 接受并可以用于启动全球药物开发计划- 深入洞察设计和提供强大临床计划的过程- 后COVID环境中的生物技术挑战和机遇，重点是全球投资和药物管道注册网络研讨会这里 https://webinars.endpts.com/the-biotech-landscape-market-trends-priorities-predictions-and-pathways-to-fda-approval/2022 年 10 月 18 日美国东部时间下午 1:00 - 下午 2:00出席的行业领导者包括：- 联生生物首席财务官易拉森。曾任 Turning Point Therapeutics, Inc. 和 Goldman Sachs & Co. LLC 执行副总裁兼首席财务官，医疗投资银行业务董事总经理- Kasey Kime，Novotech 内部咨询集团 BioDesk 的法规事务总监- Jeanne M. Novak 博士，CBR International Corp. 总裁兼首席执行官，该公司是一家提供全方位服务的产品、临床和监管战略集团- Monograph Capital Partners 的联合创始人兼董事长 Fred Cohen 博士。他还是 Vida Ventures 的联合创始人和高级董事总经理。Novotech 拥有数十年的生物技术药物开发经验、卓越的研究中心和研究人员关系、接触大量患者群体以及专注于解决问题、所有权和灵活性的项目管理方法。对高级培训和技术系统的持续投资相结合，提供专业的全方位服务生物技术临床研究机构解决方案。Novotech 最近被评为世界领先合同研究组织中的前十名合同研究组织，是著名的 Scrip 奖的决赛入围者，并且刚刚获得了基因与细胞治疗卓越奖。在亚太地区，Novotech 与主要医学研究机构签订了 50 多项领先的合作伙伴协议，为赞助商提供独家优惠。关于Novotech健康控股Novotech健康控股有限公司（“Novotech”）是亚太地区及美国领先的生物技术专家 CRO。 Novotech 是一家 CRO，拥有综合实验室和 I 期设施，提供药物开发咨询和临床开发服务。它有助于在所有试验阶段和广泛的治疗领域成功进行大约 4,000 项临床试验。Novotech具有明显优势，可以为在亚洲及美国进行临床试验的生物制药客户提供服务。详细信息请访问 https://novotech-cro.com/contact 媒体联系人David JamesE: communications@novotech-cro.com澳大利亚: +61 2 8218 2144美国: +1 415 951 3228亚洲: +65 3159 3427 Copyright 2022 亚太商讯. All rights reserved. (via SEAPRWire)

16 3 月, 2021

The third TDMall in the world opened in Sydney, Australia

HONG KONG, Mar 16, 2021 - (ACN Newswire via SEAPRWire.com) - TDMall (Group) Limited, a subsidiary of Tianda Pharmaceuticals Limited (listed on the main board of the Hong Kong Stock Exchange: 00455) has invested in the establishment of modern-style Chinese medicine clinic - TDMall, and grandly opened its third TDMall in the world, TDMall (Sydney), on 14 March in Macquarie Park, Sydney, Australia. TDMall is committed to bringing the unique benefits Chinese medicine to the people in Sydney's communities, in New South Wales and all over Australia by providing premium, accessible and comprehensive Chinese medicine health services, in order to fulfill its mission of helping people in different parts of the world with Chinese medicine! Officiating guests at the ribbon-cutting ceremony, including Mr. John Alexander OAM, MP, Member for Bennelong, New South Wales(first left), Mr. Zhou Guangming, the Australian Chinese community celebrity (second left), Mr. Simon Zhou, City of Ryde Councilor (third left).TDMall (Sydney)'s registered Chinese medicine practitioners give diagnosis to every individual in the free consultation activity to last until end of April.A number of distinguished guests attended the opening ceremony of TDMall (Sydney), including Mr. John Alexander OAM, MP, Member for Bennelong, New South Wales, Mr. Simon Zhou, City of Ryde Councilor, and Australian Chinese community celebrities including Mr. Zhou Guangming. TDMall (Sydney) is TDMall (Group)'s third Chinese medicine clinic in the world after its first clinic TDMall (Zhuhai) grandly opened on 2 May 2019 and second clinic TDMall (Hong Kong) opened in a gong-striking ceremony on 24 February 2020. TDMall (Sydney) focuses on Chinese internal medicine, Chinese medicine gynecology, Chinese medicine orthopedics & pain management, Chinese medicine cosmetology, Chinese medicine acupuncture, weight management, and cancer prevention & rehabilitation. As a proactive "giving back to the community" initiative, TDMall (Sydney) will conduct a free Chinese medicine consultation activity until the end of April to provide free consultation to 10 patients every week on their first visit to the clinic. Please make appointments by phone as the service is available on a first come, first served basis.Mr. John Alexander OAM, MP, Member for Bennelong, New South Wales gave a speech behalf of the guests, saying he welcomed TDMall to Macquarie Park, Australia's premier innovation hub to offer Chinese medicine consultation and treatment services. He added that TDMall (Group)'s decision to choose Sydney for its third TDMall reflects the close bilateral relationship between Australia and Asia.Mr. Fang Wenquan, Chairman of Tianda Pharmaceutical and Founder of TDMall, said that TDMall has achieved a domestic and foreign business layout following the opening of TDMall (Sydney). TDMall (Group) has taken 3 years opening one TDMall every year steadily and prudently to accomplish Step 1 of its "three-step" development plan. TDMall is ready to take Step 2, which includes the further expansion in the Greater Bay Area targeting Shenzhen, Guangzhou and other prefecture-level or county-level cities with the aim of opening more than 100 TDMall clinics in Guangdong province while exploring opportunities to expand to other domestic and foreign markets at the right time, as well as the construction of a Cloud technology-based Chinese medicine platform "TDMall on Cloud" to provide online AI-assisted remote diagnosis as an attempt to facilitate Chinese medicine services across country borders. TDMall will take Step 3 upon achieving Step 2, expanding the business across China and worldwide with the aim of opening more than 10,000 TDMall clinics. By integrating modern medical science with other innovative technologies, TDMall strives to become the leading Chinese medicine clinic brand, while continuing to promote the inheritance, innovation and development of Chinese medicine, as well as the use of Chinese medicine in managing people's health worldwide. EnquiryTianda Pharmaceuticals LimitedInvestor Relations DepartmentT: + 852 2545 3313E: ir@tianda.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

12 1 月, 2021

Racially abusive cricket fans risk lengthy ban

SYDNEY • Cricket Australia (CA) yesterday warned it could slap indefinite bans on any fan found to have racially abused the visiting India players during the third Test in Sydney. CA has launched an investigation with New South Wales Police following complaints by bowlers Jasprit Bumrah and Mohammed Siraj on Saturday and Sunday, which led to the ejection of six fans from the Sydney Cricket Ground (SCG). Interim chief executive Nick Hockley said: "If something has been found, we will act strongly. There are sanctions including anything up to not being permitted to come into any cricket match under Cricket Australia's jurisdiction for an indefinite period of time." Governing body International Cricket Council added that it was "incredibly disappointed" with the incidents at the SCG, while Deputy Prime Minister Michael McCormack insisted "there is no place for racism in Australia". Revealing that a probe was under way, Hockley said: "We have expressed our concern and our regret that Mohammed Siraj felt the need to go and report in the way that he did." India clung on to reach 334 for five at the close, still 73 runs adrift, leaving the series locked at 1-1 ahead of the final Test on Friday and officials are hopeful that there will be no repeat of the distasteful scenes in Brisbane. Veteran Indian spinner Ravi Ashwin has claimed it has been an ongoing problem for visiting teams, saying that he had been on the end of "nasty" abuse across four tours to the country, with Sydney the worst. "This has been a continual thing at Sydney, I have personally experienced it as well," he said. The Australia team had formed a "barefoot circle" ahead of the four-Test series against the cricketing powerhouse to demonstrate opposition to racism and celebrate Aboriginal culture, yet the problem remains deep-rooted. Australian Test star Usman Khawaja has previously said he was abused so much growing up he refused to support the national side, and claimed racism played a role in selections for the team. The batsman, who immigrated as a child, battled the odds to become Australia's first Pakistan-born national player, but admitted he faced plenty of discrimination along the way. "Getting sledged by opposition players and their parents was the norm. Some of them said it just quietly enough for only me to hear," he said. All-rounder Dan Christian has also been a victim, mostly from online trolls, revealing last year he was targeted for speaking up about "casual racism" in cricket. One of just six indigenous players to represent Australia at international level, he said it was not "as in your face as you might see elsewhere around the world" but that "it is definitely there". AGENCE FRANCE-PRESSE, REUTERS