本文翻译自美国医药行业媒体 Firece Biotech 的一篇文章,感觉俞博士挺实在的,小编觉得这条路可行,祝信达早日达成目标,也给国内其他 biotech 作为参考
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https://www.fiercebiotech.com/biotech/5-month-sprint-behind-pfizer-10b-deal-and-innovent-global-pharma-ambition
A 5-month sprint: Behind Pfizer’s $10B deal and Innovent’s global pharma ambition
一场为期5个月的冲刺:辉瑞100亿美元交易背后与信达生物的全球制药野心
Despite its massive $10.5 billion size and 12-drug scope, Pfizer’s oncology deal with Innovent Biologics took less than five months to forge, but not without undergoing some stress tests.
尽管这笔交易规模高达105亿美元、涉及12种药物,辉瑞与信达生物的肿瘤领域合作从启动到敲定仅用了不到五个月的时间,不过这一过程也经历了一些压力测试。
The deal talks started at the J.P. Morgan Healthcare Conference in San Francisco in January this year, Innovent CEO Michael Yu, Ph.D., told Fierce Biotech.
今年1月,信达生物首席执行官俞德超博士在旧金山举行的摩根大通医疗健康会议上开启了这笔交易的谈判,他向 Fierce Biotech 透露了这一消息。
From the start, Pfizer preferred a single multi-asset deal. Hunting for a dozen different assets from separate companies—and managing those alliances later—was simply too logistically cumbersome. To Innovent, the sentiment was the same.
从一开始,辉瑞就更倾向于一笔包含多种资产的交易。从不同公司寻找十几种不同资产,再在后续管理这些合作关系,在后勤上实在太过繁琐。对于信达生物来说,想法也是一样的。
Innovent has a long history of working with multinational pharma companies (MNCs), dating back to its decade-long collaboration with Eli Lilly that began in 2015 and added its seventh chapter in February.
信达生物与跨国制药企业(MNCs)的合作历史悠久,其与礼来公司的十年合作始于2015年,并于今年2月开启了合作的第七个篇章。
“We understand what MNCs want,” Yu said. “Their motivation is to cover more projects with one company, so they don’t have to keep shopping around. We feel the exact same way.”
“我们了解跨国公司的需求,”俞说,“他们的动机是通过一家公司承接更多项目,这样就不必反复货比三家。我们的想法完全一样。”
“The effort to conduct search and evaluation, due diligence, negotiations, technology transfers and alliance management on an asset-by-asset basis is not small,” Helen Chen, global sector co-head for healthcare at L.E.K. Consulting, said in an email interview with Fierce. “Having a bundled deal with multi-asset collaborations help[s] reduce the transaction efforts. Familiarity with each other's capabilities and style reduces misunderstandings and enhances efficiency.”
“对每一项资产开展调研评估、尽职调查、谈判、技术转让以及联盟管理的工作量不小,”L.E.K. Consulting 医疗保健全球部门联合负责人 Helen Chen 在接受 Fierce 邮件采访时表示。“通过打包交易开展多资产合作,有助于减少交易工作量。双方对彼此能力和行事风格的熟悉度,能减少误解并提升效率。”
Multi-asset partnerships have become more popular between Big Pharma and large Chinese companies—even though single-program deals and platform technology research alliances remain the most common, especially among smaller biotechs. Last year, GSK also signed a 12-asset deal with China’s Hengrui Pharma, potentially worth $12 billion. And Bristol Myers Squibb followed this May with a 13-program alliance with Hengrui.
大型制药企业与中国大型企业之间的多资产合作已愈发流行——尽管单项目合作和平台技术研究联盟仍是最常见的合作形式,在小型生物技术公司中尤为如此。去年,葛兰素史克(GSK)也与中国恒瑞医药签署了一项涉及12项资产的合作协议,潜在价值达120亿美元。今年5月,百时美施贵宝(Bristol Myers Squibb)紧随其后,与恒瑞医药达成了一项13个项目的合作联盟。
These large deals were made possible in recent years thanks to an enlarged pool of molecules and improved confidence in the integrity of clinical data from China, Yu said.
俞表示,近年来,得益于中国可用于研发的分子池规模扩大以及临床数据真实性信心的提升,这些大型交易得以达成。
After the JPM conference, Pfizer sent a team to China and visited several local companies, including Innovent, according to Yu.
据俞介绍,摩根大通会议结束后,辉瑞派了一个团队前往中国,拜访了包括信达生物在内的多家本土企业。
Pfizer dug into Innovent’s drug development track record and discovery engine and was “very excited in what we saw about the quality,” Johanna Bendell, M.D., Pfizer’s chief development officer of oncology, told Fierce in a separate interview.
辉瑞肿瘤学首席开发官 Johanna Bendell 医学博士在另一次采访中告诉Fierce,辉瑞深入研究了信达生物的药物开发记录和发现引擎,“对我们看到的质量感到非常满意”。
A two-way selection process ensued. Pfizer only went for drugs that fit its portfolio, leading to its selection of altogether eight existing molecules, including one already in the clinic, four in the IND-stage, and four preclinical candidates. Innovent will also design four new molecules at the request of Pfizer, which will decide whether to take them up following clinical proof-of-concept tests performed by its Chinese partner.
一场双向筛选过程随即展开。辉瑞只挑选符合其产品组合的药物,最终共选定八种现有分子,其中包括一种已进入临床试验阶段、四种处于新药临床试验申请阶段以及四种临床前候选药物。信达生物还将应辉瑞的要求设计四种新分子,辉瑞则会在其中国合作伙伴完成概念验证临床试验后,决定是否采用这些新分子。
Co-Co or no deal 共同开发或不成交
Under the deal, Innovent negotiated a term to co-develop and co-commercialize four programs that it believes holds greater market potential based on existing information, according to Yu.
据俞介绍,根据该协议,信达生物协商了一项条款,共同开发并共同商业化四个其基于现有信息认为具有更大市场潜力的项目。
Pfizer initially resisted the co-development, co-commercialization structure, Yu recalled. Leveraging interest from other parties, Innovent threatened to walk away.
俞回忆称,辉瑞最初反对共同开发和共同商业化的架构。信达生物利用其他方的兴趣,威胁要退出合作。
At least three other potential partners were interested in a colorectal cancer multi-specific antibody candidate, Yu noted. In the U.S., colorectal cancer is the third most commonly diagnosed cancer and the second-leading cause of cancer-related death, with its rates also rising in younger adults.
俞指出,至少还有另外三家潜在合作方对一款结直肠癌多特异性抗体候选药物感兴趣。在美国,结直肠癌是第三大常见确诊癌症,也是癌症相关死亡的第二大原因,且在年轻人群中的发病率也在上升。
Underlying Innovent’s insistence was an ambition to become a global pharma company.
信达生物坚持这一点的背后,是其立志成为一家全球制药企业的雄心。
“For Chinese biopharma companies, if you only focus on the domestic market, it doesn’t matter how good you are, you’re still just second- or third-tier players,” Yu said. “Innovent is a second- or third-tier company today.”
“对于中国生物制药企业来说,如果你只盯着国内市场,不管你实力多强,也只能算是二三线玩家,”俞说。“信达生物现在就是一家二三线企业。”
Market reality determines that a company with first-tier ambition must aim for the Western market. On average, a drug would get 50% to 55% of its revenue from the U.S. and 20% to 25% from Europe, while China roughly constitutes 8% of the sales and merely 3% of the profit, Yu observed.
市场现实决定,拥有一流抱负的企业必须以西方市场为目标。俞观察到,平均而言,一款药物50%至55%的收入来自美国,20%至25%来自欧洲,而中国的销售额约占8%,利润仅占3%。
For now, Innovent’s global capabilities, including clinical development, regulatory affairs and manufacturing, are not robust enough to get a novel drug across the FDA by itself, the CEO acknowledged.
信达生物的首席执行官承认,目前公司在临床开发、注册事务和生产制造等方面的全球能力还不够强大,无法仅凭自身将一款新药通过美国食品药品监督管理局(FDA)的审批。
On the commercial side, Innovent is no better than a biotech startup when it comes to reimbursement negotiations, placement on hospitals’ drug formularies, medical affairs, as well as distribution and marketing pathways in the U.S., he added.
他补充道,在商业层面,就报销谈判、医院药品目录准入、医学事务以及美国的分销和营销渠道而言,信达生物在这些方面并不比一家生物科技初创公司更有优势。
“That’s why we have to find a company that is willing to take this journey together with us,” Yu said.
“这就是为什么我们必须找到一家愿意与我们一起踏上这段旅程的公司,”俞说。
That was the same reason why Innovent pursued a co-development and co-commercialization deal structure with Takeda on a potential first-in-class PD-1/IL-2 bispecific antibody fusion protein called IBI363 (TAK-928).
这也是信达生物与武田就一款潜在的全球首创 PD‑1/IL‑2 双特异性抗体融合蛋白 IBI363 (TAK-928) 采用联合开发与联合商业化合作模式的原因。
A global 2030 plan 2030年全球计划
IBI363 is being tested in a global phase 3 trial in PD-(L)1-pretreated squamous non-small cell lung cancer, with a second phase 3 being planned in nonsquamous histology.
IBI363 正在一项针对 PD-(L)1 经治鳞状非小细胞肺癌的全球 III 期临床试验中接受测试,第二项针对非鳞状组织学类型的 III 期试验正在规划中。
The drug is among three of Innovent-developed assets that either entered or are ready to start global phase 3 trials, alongside a Claudin 18.2 ADC also included in the Takeda deal and a VEGFxAng2 bispecific that’s been partnered with newly formed eye disease specialist Ollin Biosciences.
这款药物是信达生物自主研发的三项资产之一,这三项资产均已进入或准备启动全球III期临床试验;另外两项资产分别是与武田制药合作协议中包含的一款Claudin 18.2抗体药物偶联物,以及一款已与新成立的眼科疾病专业企业Ollin Biosciences达成合作的VEGFxAng2双特异性抗体。
Innovent’s publicly disclosed goal is to grow that number to at least five assets by 2030, while the company has set more detailed internal targets, including the percentage of global sales in its overall revenues, Yu said.
俞表示,信达生物公开披露的目标是到2030年将这一数量至少增至5个产品,而该公司还制定了更具体的内部目标,包括全球销售额在其总收入中所占的比例。
The deals Innovent has signed so far “not only bring substantial financial returns to the company, but more importantly, integrate global resources to accelerate the realization of our pipeline's value and help us build the core capabilities needed for our journey to becoming a truly global biopharmaceutical company,” Yu said during Innovent’s 2025 full-year earnings call in March.
俞在今年3月信达生物2025年全年业绩电话会上表示:“信达生物迄今为止签署的合作协议,不仅为公司带来了可观的财务回报,更重要的是整合全球资源,加速我们研发管线价值的兑现,助力我们打造成为真正的全球生物制药企业所需的核心能力。”
“We are confident to propose our Vision 2030: evolving from a leading biopharmaceutical company in China into a global premier biopharmaceutical company,” he said.
“我们有信心提出我们的2030愿景:从中国领先的生物制药企业发展成为全球顶尖的生物制药企业,”他说。
Eventually, Innovent could find a niche product with a limited number of physicians involved to try launching alone in the U.S., Yu said.
俞表示,最终信达生物可以找到一款小众产品,参与的医生数量有限,从而尝试在美国自主推出该产品。
After signing the massive Pfizer deal, Innovent is taking a break from oncology business development to focus on the ones already underway, including those with Roche, Yu said. But the company remains open to striking deals in other disease areas.
俞表示,在与辉瑞达成这笔大额交易后,信达生物暂时暂停了肿瘤领域的业务拓展,转而聚焦于已在推进的项目,包括与罗氏合作的项目。不过,该公司仍愿意在其他疾病领域达成合作协议。
Innovent’s portfolio currently spreads across four large therapeutic areas: oncology, cardiovascular and metabolic disease, immunology and ophthalmology.
信达生物的产品管线目前覆盖四大核心治疗领域:肿瘤、心血管与代谢疾病、免疫学及眼科疾病。
To Yu, becoming a global pharma also means narrowing down. Admiring how disciplined Big Pharma companies are in their selection of focus areas, Yu suggested that Innovent’s pipeline is too broad for a company of its size.
对于信达生物而言,成为一家全球性制药企业也意味着聚焦。信达生物欣赏大型制药公司在选择核心领域时的严谨态度,因此认为以其目前的规模,创新生物的研发管线过于宽泛。
He raised the example of oncology. While there are about 2,000 tumor types, pharma companies typically only focus on three to four cancers, he said.
他举了肿瘤学的例子。他表示,虽然肿瘤类型约有2000种,但制药公司通常只关注三到四种癌症。
“We ought to cut 50% of [disease areas] in the future,” Yu said. “We should be more focused.”
“我们未来应该砍掉50%的[疾病领域],”俞说。“我们应该更专注。”