Tridem Pharma SA

11月20日，复星医药美国公司（Fosun Pharma USA，以下简称“复星美国”）和Treehill Partners（Treehill）宣布成立联合运营主体，用于临床阶段资产投资。这一新成立的业务将寻找专注于美国市场高质量的中后期资产，还将高度关注非美国市场，但寻求进入美国市场的高质量的临床阶段生物制药资产。创新产品“美国的权益可以独立谈判，不需要与其他地区挂钩”。复星医药美国官网的一句话完美诠释了这次合作。这一战略举措，被视为复星医药美国公司成长历程新篇章的开始。自2017年，国内药企轰轰烈烈踏上一场国际化征程。六年过去，轻舟已过万重山，这场国际化征程开始“裂变”，发出新芽。当前多个国产创新药在美国获批上市，中国出海也进入到新的阶段，复星医药或提供了一个新的探索方向，同时在这场征程当中，很多企业也找到了适合自己的道路。01六年前埋下的种子，开始裂变故事还得回到2017年。随着中国正式加入ICH，中国创新药企“出海热”在这一年迅速升温。彼时，复星医药的国际化雄心同样得到了急速扩张。翻开2017年财报，可清晰看见复星医药当年的种种“大手笔”：从年初与Kite Pharma设立复星凯特，再到并购印度药企Gland Pharma、法国药品分销公司Tridem Pharma、瑞典医疗器械公司Breas……也是在这一年，复星美国应运而生，同年成立的还有复星医药欧洲分公司。自此，这家位于新泽西州普林斯顿的复星美国开始了数年的野蛮生长，并根据自身处境一再做出应时的调整。成立之初，复星美国主要提供一系列可靠的专业药品注射剂和眼科药品批发，如骨化三醇注射液、丙氯拉嗪乙二磺酸盐注射液等成熟产品。这几年，伴随着创新语境变得更浓，复星美国也开始代理创新产品，通过许可、共同开发、合资或收购来扩大产品线，不过其大多数产品都来自于复星医药其他子公司，如复宏汉霖、复星弘创、F0CHON、Novelstar等。以国内耳熟能详的H药来说，自从2022年12月，复宏汉霖与复星医药达成合作，授予其在美国对复宏汉霖自主开发的PD-1斯鲁利单抗（H药）进行独家商业化的权益，而该重担便是交到了复星美国手里。现在复星美国以及他背后的复星医药想在国际化上再下一城——参与到美国创新药资产的整合中。原因是，复星美国看到了现今的机会所在：一方面可用于生物技术产品开发的资金有限，行业出现停滞，大量临床项目无法推进；另一方面，不少Biotech缺乏往前推进的技能。而也正因此，复星美国选择牵手Treehill Partners，成立联合运营主体，用于临床阶段资产投资。据了解，Treehill Partners在跨企业和产品开发的端到端能力方面已被证明具有良好的记录。这一新成立的业务板块将寻找专注于美国市场高质量的中后期资产，还将高度关注非美国市场寻求进入美国市场的高质量临床阶段生物制药资产，代理他们在美国市场的权益，当然首先会考虑全球权益。值得一提的是，复星美国强调，虽然该业务可促进与母公司在中国市场的合作，但他们明确关注的是创新生物制药的美国权利。“美国的权利可以独立谈判，不需要与其他地区挂钩”。该合作部门由复星医药美国运营总部首席执行官杨荣和Treehill首席执行官Ali Pashazadeh共同领导，将寻求在2024年进行首次投资。而投资生命周期中的所有活动——从战略制定、目标确定和投资、产品和业务开发，到价值实现和战略退出选择，都将得到共同管理。这一战略举措，不仅被视为复星美国成长历程新篇章的开始，也给行业提供了一种新方向，同时预示着国内药企在国际化征程往更全球化的新信号。02在美获批新元年出海不是一个新话题，但过程里的故事和主角却时时在变，我们尤其需要关注那些关键时刻。当特瑞普利单抗、呋喹替尼、艾贝格司亭α注射液接连获得美国FDA批准上市，中国创新药出海已经进入一个新的里程碑，这个里程碑的底子是我们的创新底色，催化剂是国际环境的改善。正如两三年前，也即2020年，行业里伴随PD-(L)1、CD47、SHP2相继授权给MNC药企，创新药步入License out爆发的元年。这一年，交易数量攀升至39笔，而此前的三年每年不超过10笔。后来，License out交易成了行业里的“家常便饭”，甚至成为寒冬里Biotech获取资金的重要甚至主要渠道。过程里，有高昂也有低洼，“中国ADC”因此成为创新最绚烂的名片，美国难攻先从“一带一路”也不失为好的路径；另一面随着合作的推进，退货常态下大家逐渐开始关注首付款。种种迹象都表明，中国创新药企的出海探索，已经进入“新药在美获批上市收获期”的起点。接下来，更重要的是在美国的商业化该怎么做？显而易见，中国尚未建立在海外的商业化能力。过往在美国上市的创新药，百济神州的泽布替尼商业化是“自建+合作”的方式，而传奇生物的西达基奥仑赛是由强生来商业化。而近期获批的这三款，君实生物的PD-1由Coherus代理，预计将于2024年第一季度投入商业运营，从过往记录上可以看到Coherus在生物类似药的销售上有良好的记录。刚获批的呋喹替尼在美商业化则是由武田负责，值得一提的是，呋喹替尼在美上市后，48小时内就在美国开出了首张处方，尤其可以一窥MNC药企在美的商业化实力。亿帆医药的艾贝格司亭α注射液在美国的独家经销权，则许可给了ACROTECH公司。ACROTECH是Aurobindo（阿拉宾度）的子公司，该公司在美国50个州拥有广泛的销售队伍和完善的销售网络。总体来看，依靠自建的商业化团队在美国商业化历程仍然漫长且艰难。但需要明确的是，美国商业化的探索过程，注定艰难但关键，是中国药企真正站上国际舞台的窗口。这一窗口期里，不仅是中国药企与中国药企的竞争，更多的是中国药企与全球药企的竞争。如何融入大潮，当立潮头？复星医药美国给了一种方式，他在现在的时间节点下，通过BD方式参与到美国市场创新资产的整合上，在合作里淬炼自身的商业化能力。复星的模式基于过去的路径积累，不一定适合所有药企。更好的方式是找到自己的优势，并发挥长处。比如百济神州，全球临床开发能力在中国一骑绝尘，因而帮助中国药企将早期资产通过国际临床开发推向美国市场，可能是共赢的选择，百济在多个产品的商业化中也能更实在的落地和积淀其商业化能力。当然更多的药企是，既没有复星过往沉淀的海外资源和独特模式，也没有百济的全球化开发能力。对于他们，更现实的选择是找到合适的合作伙伴。比如恒瑞医药在一系列国际化探索后，希望将License out作为自己当前阶段出海的主要方式；比如康方生物选择合作伙伴，不选大只选对，临床推进的结果也在说明这是好的方式。不管选择何种方式，他们的共同点是更理性了，都只做自己擅长的，我们也期待创新药在海外的厚积薄发。声明：本文11月21日首发于《E药经理人》（ID：eyjlr2013），经授权转载，如需二次转载请联系原作者。E药经理人媒体平台致力于成为医药行业意见领袖平台，记录和观察医药重大商业事件，展现行业的复杂与冲突，提供最前沿的思想洞见。 阅读原文，是昨天最受欢迎的文章哦

中国药企在美国，整合美国的创新临床资产，并在美国市场商业化，这确实释放了中国药企在国际化上的新信号。11月20日，复星医药美国公司（Fosun Pharma USA，以下简称“复星美国”）和Treehill Partners（Treehill）宣布成立联合运营主体，用于临床阶段资产投资。这一新成立的业务将寻找专注于美国市场高质量的中后期资产，还将高度关注非美国市场，但寻求进入美国市场的高质量的临床阶段生物制药资产。创新产品“美国的权益可以独立谈判，不需要与其他地区挂钩”。复星医药美国官网的一句话完美诠释了这次合作。这一战略举措，被视为复星医药美国公司成长历程新篇章的开始。自2017年，国内药企轰轰烈烈踏上一场国际化征程。六年过去，轻舟已过万重山，这场国际化征程开始“裂变”，发出新芽。当前多个国产创新药在美国获批上市，中国出海也进入到新的阶段，复星医药或提供了一个新的探索方向，同时在这场征程当中，很多企业也找到了适合自己的道路。六年前埋下的种子，开始裂变故事还得回到2017年。随着中国正式加入ICH，中国创新药企“出海热”在这一年迅速升温。彼时，复星医药的国际化雄心同样得到了急速扩张。翻开2017年财报，可清晰看见复星医药当年的种种“大手笔”：从年初与Kite Pharma设立复星凯特，再到并购印度药企Gland Pharma、法国药品分销公司Tridem Pharma、瑞典医疗器械公司Breas……也是在这一年，复星美国应运而生，同年成立的还有复星医药欧洲分公司。自此，这家位于新泽西州普林斯顿的复星美国开始了数年的野蛮生长，并根据自身处境一再做出应时的调整。成立之初，复星美国主要提供一系列可靠的专业药品注射剂和眼科药品批发，如骨化三醇注射液、丙氯拉嗪乙二磺酸盐注射液等成熟产品。这几年，伴随着创新语境变得更浓，复星美国也开始代理创新产品，通过许可、共同开发、合资或收购来扩大产品线，不过其大多数产品都来自于复星医药其他子公司，如复宏汉霖、复星弘创、F0CHON、Novelstar等。以国内耳熟能详的H药来说，自从2022年12月，复宏汉霖与复星医药达成合作，授予其在美国对复宏汉霖自主开发的PD-1 斯鲁利单抗（H药）进行独家商业化的权益，而该重担便是交到了复星美国手里。现在复星美国以及他背后的复星医药想在国际化上再下一城——参与到美国创新药资产的整合中。原因是，复星美国看到了现今的机会所在：一方面可用于生物技术产品开发的资金有限，行业出现停滞，大量临床项目无法推进；另一方面，不少Biotech缺乏往前推进的技能。而也正因此，复星美国选择牵手Treehill Partners，成立联合运营主体，用于临床阶段资产投资。据了解，Treehill Partners在跨企业和产品开发的端到端能力方面已被证明具有良好的记录。这一新成立的业务板块将寻找专注于美国市场高质量的中后期资产，还将高度关注非美国市场寻求进入美国市场的高质量临床阶段生物制药资产，代理他们在美国市场的权益，当然首先会考虑全球权益。值得一提的是，复星美国强调，虽然该业务可促进与母公司在中国市场的合作，但他们明确关注的是创新生物制药的美国权利。“美国的权利可以独立谈判，不需要与其他地区挂钩”。该合作部门由复星医药美国运营总部首席执行官杨荣和Treehill首席执行官Ali Pashazadeh共同领导，将寻求在2024年进行首次投资。而投资生命周期中的所有活动——从战略制定、目标确定和投资、产品和业务开发，到价值实现和战略退出选择，都将得到共同管理。这一战略举措，不仅被视为复星美国成长历程新篇章的开始，也给行业提供了一种新方向，同时预示着国内药企在国际化征程往更全球化的新信号。在美获批新元年出海不是一个新话题，但过程里的故事和主角却时时在变，我们尤其需要关注那些关键时刻。当特瑞普利单抗、呋喹替尼、艾贝格司亭α注射液接连获得美国FDA批准上市，中国创新药出海已经进入一个新的里程碑，这个里程碑的底子是我们的创新底色，催化剂是国际环境的改善。正如两三年前，也即2020年，行业里伴随PD-(L)1、CD47、SHP2相继授权给MNC药企，创新药步入License out爆发的元年。这一年，交易数量攀升至39笔，而此前的三年每年不超过10笔。后来，License out交易成了行业里的“家常便饭”，甚至成为寒冬里Biotech获取资金的重要甚至主要渠道。过程里，有高昂也有低洼，“中国ADC”因此成为创新最绚烂的名片，美国难攻先从“一带一路”也不失为好的路径；另一面随着合作的推进，退货常态下大家逐渐开始关注首付款。种种迹象都表明，中国创新药企的出海探索，已经进入“新药在美获批上市收获期”的起点。接下来，更重要的是在美国的商业化该怎么做？显而易见，中国尚未建立在海外的商业化能力。过往在美国上市的创新药，百济神州的泽布替尼商业化是“自建+合作”的方式，而传奇生物的西达基奥仑赛是由强生来商业化。而近期获批的这三款，君实生物的PD-1由Coherus代理，预计将于2024年第一季度投入商业运营，从过往记录上可以看到Coherus在生物类似药的销售上有良好的记录。刚获批的呋喹替尼在美商业化则是由武田负责，值得一提的是，呋喹替尼在美上市后，48小时内就在美国开出了首张处方，尤其可以一窥MNC药企在美的商业化实力。亿帆医药的艾贝格司亭α注射液在美国的独家经销权，则许可给了ACROTECH公司。ACROTECH是Aurobindo（阿拉宾度）的子公司，该公司在美国50个州拥有广泛的销售队伍和完善的销售网络。总体来看，依靠自建的商业化团队在美国商业化历程仍然漫长且艰难。但需要明确的是，美国商业化的探索过程，注定艰难但关键，是中国药企真正站上国际舞台的窗口。这一窗口期里，不仅是中国药企与中国药企的竞争，更多的是中国药企与全球药企的竞争。如何融入大潮，当立潮头？复星医药美国给了一种方式，他在现在的时间节点下，通过BD方式参与到美国市场创新资产的整合上，在合作里淬炼自身的商业化能力。复星的模式基于过去的路径积累，不一定适合所有药企。更好的方式是找到自己的优势，并发挥长处。比如百济神州，全球临床开发能力在中国一骑绝尘，因而帮助中国药企将早期资产通过国际临床开发推向美国市场，可能是共赢的选择，百济在多个产品的商业化中也能更实在的落地和积淀其商业化能力。当然更多的药企是，既没有复星过往沉淀的海外资源和独特模式，也没有百济的全球化开发能力。对于他们，更现实的选择是找到合适的合作伙伴。比如恒瑞医药在一系列国际化探索后，希望将License out作为自己当前阶段出海的主要方式；比如康方生物选择合作伙伴，不选大只选对，临床推进的结果也在说明这是好的方式。不管选择何种方式，他们的共同点是更理性了，都只做自己擅长的，我们也期待创新药在海外的厚积薄发。回复“15周年”，了解电子期刊详情登记邮箱信息订阅E药经理人信息服务扫描二维码精彩推荐CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化 ｜ 猎药人系列专题启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖 ｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 |  荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药 ｜再鼎医药｜亚虹医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

HONG KONG, April 27, 2023 /PRNewswire/ -- A song spreads throughout the world from the Premier League fields; a seminar explores how civilian orgnanizations can carry out charitable activities for long-term effect in Africa; and a charity "relay race" starts at Guilin, China, where artesunate was discovered, and ends in the African continent, the front line in the fight against malaria....... In response to the theme of this year's World Malaria Day (April 25) – "Time to deliver zero malaria through investment, innovation, and implementation", Fosun collaborated with its member companies and eco-partners in more than 15 countries and regions in a campaign for a malaria-free world through a variety of charitable activities from April 20 to April 26, and help mankind build a healthy and better future. Leveraging its innovation and global operations capabilities built up over the past 30 years, Fosun continues to seek better solutions and has partnered with non-profit organizations to help the world become "malaria-free". As of the end of 2022, Fosun Pharma, the company's flagship platform in the health sector, has distributed over 280 million independently researched and developed artesunate for injection globally, saving the lives of more than 56 million people with severe malaria, the majority of whom are African children. The Fosun Pharma's production facility in an industrial park in Abidjan, the economic centre of Ivory Coast in West Africa, was officially launched in November 2022, and it will improve access to pharmaceuticals such as artesunate in Africa and thus enhance the continent's emergency response capability. A Song Calling for a "Malaria-free" World Spreads Throughout Premier League fields, and a Charity Run from Guilin to Africa Begins "Together we build a malaria-free world..." When British singer Sophia Saffarian performed "Better Days," a charity song especially created by Fosun for the World Malaria Day, in the middle of the stadium on the evening of April 25, local time in the UK, during a recess in a match played between the Wolverhampton Wanderers F.C. and Crystal Palace Football Club in the 33rd round of the FA Premier League, she whipped up the audience's enthusiasm in the entire Molineux Stadium. Tens of thousands of fans joined both the host and away teams in spreading the idea of "building a malaria-free world" throughout the world that evening. "We will be the generation to put an end to malaria." The players from the Wolverhampton Wanderers F.C. recorded a public service video to voice their support for the fight against malaria and to encourage more people to care about the people suffering from malaria on another continent on the same globe. Four hours earlier, at 21:00 Beijing time on April 25, city landmarks in China million miles away from the Premier League fields such as Shanghai Bund Finance Center, Shanghai Forte Vitality City, Chengdu Fuyuehui, Chongqing Fuyuehui, Wuhan Fuyueli, Changsha Forte Starlight World, Suzhou Fuyue City, Quanzhou Xingguangyao, and Ningbo Fuyue City, displayed the slogan "Build a malaria-free world" in lights. For the third consecutive year, Fosun's landmark project 28 Liberty was illuminated for the global fight against malaria at Fosun Plaza in Manhattan, New York, calling on the local community to continue to care about global public health and support the "Zero Malaria" initiative. Since 2021, Fosun Hive's overseas operations have been actively involved in the worldwide anti-malaria lighting campaign. This year, Fosun Hive expanded the campaign to three continents, with more than 10 platforms and property projects in five countries including: 28 Liberty in New York, The Court Hotel (Hiroshima, Kyoto, Ise) in Japan, Fosun Hive Capital in Singapore, Royal Exchange, Vantage, Smithson Plaza and Moretown in London, UK Gland Pharma and Tridem Pharma in India. The whole world paused for the noble vision of human health as Fosun's landmarks around the world are all illuminated to show the company's determination to join the worldwide efforts to fight malaria. An international charity run has already begun. On April 20, Fosun employees and non-profit partners at home and abroad, sporting the slogan "Together we build a malaria-free world" on their T-shirts, have started a charity run, calling for joint efforts to build a malaria-free world. The route started in Guilin, Guangxi, the birthplace of the ground-breaking anti-malaria drug artesunate, and runs through the Huangpu River, West Lake, and Xiangjiang River in China, the United States, Singapore, Angola, and Mozambique. On April 21, with the joint support of Co-construction and Co-governance Alliance on the Bank of Huangpu River in Xuhui District, Fosun Center on the Bank of Huangpu River in Xuhui District, Fosun Trade, Resource, Xingjia, Fosun Selection, Fosun Leadership Academy, Mint Health, fitt8, Fuheng Insurance Brokers, Wolverhampton Wanderers F.C., and Club Med, Fosun Foundation, together with six running teams from Fosun Pharma, Fosun Commercial Group, Fosun Insurance, Yuyuan Jewelry, Forte Industrial Development Group, and Resource Eco-Running League and Co-governance Alliance ran along on the Bank of Huangpu River in Xuhui District for the cause of "Building a Malaria-Free World". "Many of the elderly members of my family still have vivid memories of malaria. They remember that when they get sick, their bodies experience cold and fever alternately, which is commonly known as 'Dabaizi' in the local dialect. After more than 70 years of efforts, China was certified as a 'malaria-free country' by the WHO in 2021. China is bow malaria-free but Africa is still plagued by the disease. I took part in the relay run to raise the public awareness of malaria and to contribute to the global effort to eradicate the disease," said a Fosun employee who participated in the charity run in Shanghai. China and Africa Join hands to Advocate Charity Activities with Long-term Effect The 16th National Malaria Day falls on April 26. On the afternoon of that day, representatives from government departments such as Shanghai Municipal Foreign Affairs Office and Shanghai Municipal External Publicity Office, international and domestic organizations such as Bill & Melinda Gates Foundation, as well as many charitable enterprises, gathered at Shanghai Bund Financial Center to meet with scholars and experts on malaria and representatives of Fosun member enterprises at the "Seminar on China's Non-governmental Support to Charitable Activities with Long-term Effect in Africa". They deliberated on how Chinese non-governmental organizations and civilians could establish a mechanism for charitable activities with long-term effect in Africa. The World Malaria Report, published in December 2022, estimates that malaria killed roughly 619,000 people in 2021. WHO African Region continued to shoulder the heaviest burden of coping with malaria - 95 percent of all malaria cases (234 million) and 96 percent of deaths (593,000) occurred in Africa; and children under the age of five accounted for approximately 80 percent of malaria deaths in the Africa. Increasing the availability of medications is one of the solutions to the issue. In fact, over the past ten years, China's anti-malaria products and medicines, as well as its standards of anti-malaria practices, have been widely recognized, especially by WHO and the international community. The "China Solution" is helping developing countries eradicate malaria. "Africa satisfies 90% of its demand for medicines with imports. Therefore, the establishment of a pharmaceutical logistics and distribution network covering sub-Saharan African countries and the construction of regional distribution centers will effectively streamline the system and shorten the time for the distribution of medicines," said an expert at the seminar. Fosun Pharma has established sales networks in 39 countries and regions in Africa after operating locally for more than 15 years, according to Xiong Yanjie, a representative of the company at the seminar. "Through the distribution network of its majority-owned subsidiary Tridem Pharma, Fosun Pharma can distribute the anti-malaria and antibiotic products produced at its factory in Abidjan, Ivory Coast. This will enable the localization of the supply of conventional drugs in Ivory Coast and the other parts of West Africa, thus lowering the risk of drug shortages." For Fosun Pharma, opening a pharmaceutical plant in Ivory Coast is a crucial step toward localized production and distribution of medicines in Africa. It is said that the first phase of the production facility is expected to be completed in 2024, when one billion tablets of oral solid dosage will be able to be produced and packaged locally. To reduce the rate of childhood malaria infection, Fosun Pharma developed SPAQ-CO® Disp (sulfadoxine-pyrimethamine dispersible tablets/amodiaquine dispersible tablets in collective packages), a preventive drug for malaria in children which was pre-certified by the World Health Organization (WHO-PQ) in August 2018. As of the end of 2022, more than 210 million children in Africa have benefitted from the Seasonal Malaria Chemoprevention Program with SPAQ-CO products as the core drug. Xu Fujie, Deputy Chief Representative of the Bill & Melinda Gates Foundation's Beijing Representative Office, expressed her appreciation for Fosun Pharma's efforts in the fight against malaria, and said that the Gates Foundation was sharing the Chinese experience in combating the disease with Africa, and hoped to work with Fosun Pharma to deliver more Chinese medicines to Africa. To end malaria infection, experts at the seminar emphasized that prevention is more crucial than treatment and that, in addition to medicines, comprehensive solutions targeted at grassroots communities are urgently required. These solutions include improving environmental sanitation, changing personal hygiene practices, and setting up primary healthcare systems. As a co-organizer of the seminar, the Amity Foundation, one of the oldest local foundations in China, introduced its community education and medical projects in Africa. It hoped to work with Fosun to build a platform on which more Chinese enterprises and social welfare organizations will be able to work in Africa, thus contributing to the common good of humanity. Fosun International chairman Guo Guangchang said, "We have taken root in Shanghai and are working for the whole world. As a multinational company with its roots in China, Fosun leverages its innovation and global operation capabilities built up over the years when it actively works for public health and engages in charitable causes. In addition to bringing pharmaceuticals to Africa, we also bring grassroots experience in launching programs such as the rural doctor program in China. We will uphold our original aspiration of 'Contribution to Society' and help more people around the world enjoy a healthier and happier life. In the future, Fosun will collaborate with anti-malaria specialists and other resources to aid in the eradication of malaria in Africa and other regions with high prevalence of the disease, thus manifesting the "Fosun power" in the joint effort to build of a "malaria-free world". SOURCE Fosun