編者按：“讓天下沒(méi)有難做的藥，難治的病”，是初心，更是愿景。二十五年來(lái)，藥明康德步履不停：從一間實(shí)驗(yàn)室，到覆蓋亞洲、歐洲和北美的全球網(wǎng)絡(luò)。從早期的化學(xué)合成服務(wù)，到貫穿研究（R）、開(kāi)發(fā)（D）和生產(chǎn)（M）的一體化平臺(tái)。從第一位客戶，到全球三十多個(gè)國(guó)家的數(shù)千合作伙伴。不斷發(fā)展的，是規(guī)模與能力；始終堅(jiān)守的，是夢(mèng)想與承諾。

致敬來(lái)時(shí)路，共譜新篇章！在二十五周年之際，我們以“逐夢(mèng)者”視角，回顧藥明康德成長(zhǎng)發(fā)展的崢嶸歲月，回望賦能客戶創(chuàng)新的并肩往事，更以獨(dú)特的“藥明精神”展望未來(lái)新篇章。

那個(gè)下午本來(lái)再普通不過(guò)，直到電話響起，約翰·胡德（John Hood）博士接到噩耗：他所熟知的一位患者離世了。

一款名為fedratinib的在研藥物曾經(jīng)控制住了她的病情。這是約翰早年在TargeGen擔(dān)任研發(fā)負(fù)責(zé)人時(shí)帶領(lǐng)團(tuán)隊(duì)開(kāi)發(fā)的強(qiáng)效JAK2抑制劑。在臨床試驗(yàn)中，這款藥給不少患者帶來(lái)了明顯的改善。但意外出現(xiàn)的不良事件，讓臨床試驗(yàn)被迫暫停。原本依賴藥物維持病情的患者被迫停藥，重新尋找替代方案。那位患者最終沒(méi)能等到新的治療希望。

對(duì)約翰來(lái)說(shuō)，這不僅令人心碎，更是一種召喚。

“那一天，我意識(shí)到，我必須把這款藥帶回來(lái)?！彼f(shuō)。

他很快創(chuàng)立了Impact Biomedicines，目標(biāo)只有一個(gè)：重新推動(dòng)fedratinib的臨床開(kāi)發(fā)，讓它真正回到患者手中。

但要做到這一點(diǎn)并不簡(jiǎn)單，必須以驚人的速度彌補(bǔ)化學(xué)、生產(chǎn)、監(jiān)管等眾多準(zhǔn)備工作。而一家公司，尤其是初創(chuàng)公司，很難獨(dú)自撐起這一切。

約翰第一時(shí)間就想到一個(gè)名字：曾幫助他“以不可思議的速度”推進(jìn)研發(fā)的合作伙伴：藥明康德。

當(dāng)“速度”決定了承諾能否兌現(xiàn)

時(shí)間倒回十年前。TargeGen剛剛起步，資源有限，而約翰追尋的，是當(dāng)時(shí)看來(lái)相當(dāng)激進(jìn)的構(gòu)想：靶向骨髓纖維化中的突變酶JAK2。當(dāng)時(shí)，患者幾乎沒(méi)有治療選擇，大多數(shù)確診后只能存活幾年。

團(tuán)隊(duì)最終發(fā)現(xiàn)了fedratinib，這是一款有望顯著改變疾病進(jìn)程的高選擇性JAK2抑制劑。然而從科學(xué)突破走到臨床候選藥物之間，還有無(wú)數(shù)繁瑣而關(guān)鍵的環(huán)節(jié)：標(biāo)準(zhǔn)化生產(chǎn)、分析方法、監(jiān)管要求……樣樣都不能出差錯(cuò)。

藥明康德依托其一體化的新藥研發(fā)賦能平臺(tái)與TargeGen合作，將科研團(tuán)隊(duì)的早期發(fā)現(xiàn)轉(zhuǎn)化為高質(zhì)量的臨床材料，并建立了穩(wěn)定的工藝和生產(chǎn)體系。從發(fā)現(xiàn)先導(dǎo)化合物到首次概念驗(yàn)證，僅用了一年時(shí)間。

“當(dāng)時(shí)，這樣的速度是前所未聞的?！奔s翰回憶道。

試驗(yàn)結(jié)果令人鼓舞。Fedratinib給許多患者帶來(lái)了新的轉(zhuǎn)機(jī)。即便意外不良事件的出現(xiàn)一度阻礙其上市進(jìn)程，約翰對(duì)它的信心從未動(dòng)搖，也從未忘記曾并肩加速其研發(fā)進(jìn)展的合作伙伴。

當(dāng)Impact重新拿回藥物開(kāi)發(fā)權(quán)時(shí)，他們?cè)O(shè)定了一個(gè)看似“不可能”的目標(biāo)：在十四個(gè)月內(nèi)完成三批注冊(cè)級(jí)別fedratinib的生產(chǎn)。

項(xiàng)目時(shí)間緊、任務(wù)重，直接關(guān)系到藥品的上市速度。藥明康德接下了這個(gè)挑戰(zhàn)，并最終將藥物提前交付給Impact公司。

“在規(guī)模、質(zhì)量和速度三方面能同時(shí)做到最好，這不是每家公司都做得到的。”約翰說(shuō)。

2019年，fedratinib終于獲得美國(guó)FDA的批準(zhǔn)。這不僅是約翰職業(yè)生涯的高光時(shí)刻，更是承諾的兌現(xiàn)：

那些曾經(jīng)無(wú)助等待的患者，終于等到了屬于他們的藥物。

逆轉(zhuǎn)“不可逆”

在讓fedratinib“起死回生”之后，約翰并沒(méi)有停下腳步。

他成立了Endeavor Biomedicines，把目光投向特發(fā)性肺纖維化（IPF）。這種疾病會(huì)讓肺逐漸失去彈性，最終使患者無(wú)法呼吸?，F(xiàn)有療法只能延緩病情惡化，卻無(wú)法逆轉(zhuǎn)肺部損傷。

Endeavor的研發(fā)策略，瞄準(zhǔn)了在組織修復(fù)中至關(guān)重要的Hedgehog信號(hào)通路。

在一項(xiàng)2a期臨床試驗(yàn)中，其候選藥物展現(xiàn)出前所未有的結(jié)果：患者肺部纖維化狀況出現(xiàn)了逆轉(zhuǎn)。

“在那么短的12周內(nèi)看到肺功能改善，讓我們意識(shí)到IPF也許并不是絕癥?！奔s翰說(shuō)。

不久前，這款在研療法成為首個(gè)獲歐洲藥品管理局（EMA）授予PRIME認(rèn)定的IPF療法。

推動(dòng)這一進(jìn)展的過(guò)程同樣是一場(chǎng)與時(shí)間的賽跑。

Endeavor從另一家藥企獲得這款療法的開(kāi)發(fā)權(quán)益時(shí)，從先前許可方獲得的原料即將過(guò)期，臨床試驗(yàn)進(jìn)度面臨危機(jī)。

藥明康德與Endeavor再次攜手，并肩設(shè)計(jì)了全新的并行合成工藝，不僅順利保障了藥物供應(yīng)的連續(xù)性，還提升了產(chǎn)率和純度，確保臨床試驗(yàn)按時(shí)啟動(dòng)。

“在我們這個(gè)行業(yè)，時(shí)間就是生命。”約翰感嘆道，“而他們永遠(yuǎn)能在關(guān)鍵節(jié)點(diǎn)給出高質(zhì)量、準(zhǔn)時(shí)的交付。”

如今，這款新藥的后續(xù)開(kāi)發(fā)工作，正在四大洲、十余個(gè)國(guó)家與地區(qū)推進(jìn)。

對(duì)那些每一天都感到呼吸在流失的患者來(lái)說(shuō)，每爭(zhēng)取一周，都意義重大。

合作驅(qū)動(dòng)精準(zhǔn)創(chuàng)新

在聚焦于逆轉(zhuǎn)肺纖維化的同時(shí)，Endeavor的另一個(gè)項(xiàng)目是一款抗癌的抗體偶聯(lián)藥物（ADC），靶向一種比HER2表達(dá)更為廣泛的受體，可能為缺乏治療選擇的癌癥帶來(lái)全新方案。

但ADC的制造本身就像在走鋼絲。幾十道工藝環(huán)環(huán)相扣，任何效率上的差一點(diǎn)，都可能讓本來(lái)可行的藥變得不可及。

圖片來(lái)源：123RF

藥明康德與Endeavor重新設(shè)計(jì)了關(guān)鍵合成步驟，將整體產(chǎn)率提升了10%以上，同時(shí)提高純度和穩(wěn)定性。

“這不是小優(yōu)化?！奔s翰說(shuō)，“它直接改變了整個(gè)項(xiàng)目的可行性?！?/strong>

在他看來(lái)，這正體現(xiàn)了藥明康德的核心能力?！八麄儾粌H執(zhí)行力強(qiáng)，而且不斷創(chuàng)新。無(wú)論面對(duì)什么樣的挑戰(zhàn)，總能迅速給出高質(zhì)量解決方案?！?/p>

很多人會(huì)說(shuō)，在藥物開(kāi)發(fā)中，“速度、質(zhì)量、成本，三者只能取其二?！?/p>

約翰笑了笑：“藥明康德打破了這條規(guī)則。他們持續(xù)穩(wěn)定地做到三者兼得。而這就是我為何不斷回來(lái)與他們合作的原因。”

“始終是那個(gè)可靠的伙伴”

如今，Endeavor正在推進(jìn)IPF項(xiàng)目的2b期臨床試驗(yàn)，并不斷擴(kuò)展其腫瘤學(xué)管線。

當(dāng)被問(wèn)到與藥明康德二十年的合作意味著什么時(shí)，約翰沒(méi)有猶豫：

“每一次新藥成功獲批，都是我們職業(yè)生涯中最重要的時(shí)刻。藥明康德從骨髓纖維化到IPF、再到癌癥項(xiàng)目，都站在我們身邊。他們始終是那個(gè)可靠的伙伴?！?/p>

“在復(fù)雜的全球試驗(yàn)推進(jìn)過(guò)程中，有太多不確定性，但CMC從來(lái)不是我們需要擔(dān)心的部分?！?/p>

他說(shuō)著停頓了一下，語(yǔ)氣放輕，卻格外堅(jiān)定：

“我很幸運(yùn)，在職業(yè)生涯的早期就選擇與他們合作。每當(dāng)我有不同的嘗試，我都會(huì)再次意識(shí)到，最初的選擇是對(duì)的。”

“我很難想象，會(huì)選擇其他伙伴。”

藥物研發(fā)是一場(chǎng)漫長(zhǎng)的接力，有些人奔跑，是為了兌現(xiàn)一句承諾。有些公司陪跑，是為了讓承諾抵達(dá)現(xiàn)實(shí)。

A Promise Fulfilled: Dr. John Hood and the Two-Decade Partnership with WuXi AppTec

Editor’s Note:“Every drug can be made and every disease can be treated”. Over the past 25 years, from a single laboratory to a global network spanning Asia, Europe, and North America; from early chemical synthesis services to an integrated platform that connects Research (R), Development (D), and Manufacturing (M); from its very first customer to thousands of partners across more than 30 countries, WuXi AppTec has never stopped moving forward to realize its enduring vision.

In tribute to the journey and in celebration of new beginnings, we look back through the eyes of our “dream-makers”: revisiting the stories of partnership that empowered global innovation, and the unique spirit that continues to guide us toward the next chapter.

The call came on an otherwise ordinary afternoon. A patient, one Dr. John Hood had met personally, was gone. She died because the illness progressed after she lost access to the experimental drug that had been keeping it in check. The medicine was fedratinib, a potent JAK2 inhibitor Hood had helped bring into existence years earlier at TargeGen. The compound was real, the data compelling, but development had stalled, and the molecule sat in limbo.

For Hood, the news wasn’t just a heartbreak. It was a summons. “That day,” he later recalls,“I decided I had to bring the drug back.”Within months he founded Impact Biomedicines, assembling a small team with a single purpose: to resurrect fedratinib and carry it all the way to patients. To do that, he needed chemistry, manufacturing, and regulatory readiness faster than any young biotech could build alone.He turned instinctively to the same collaborator that had once helped him compress discovery timelines to record speed: WuXi AppTec.

When Speed Became the Difference Between Promise and Reality

About a decade earlier, in the early days of TargeGen, John Hood was chasing an idea that few believed possible: targeting a single mutant enzyme, JAK2, that drives myelofibrosis, a rare and devastating blood cancer. At that time, patients faced limited options, and most succumbed within a few years of diagnosis. For a young biotech with limited resources, turning a concept into a clinic-ready drug seemed like a distant goal.

Hood’s team led the scientific discovery, identifying fedratinib as a highly selective JAK2 inhibitor with the potential to change the course of the disease. But transforming that molecule into a therapy required scale, precision, and speed. WuXi AppTec, serving as an integrated CRDMO platform, stepped in to enable what would become a record-setting advance. Its chemists translated TargeGen’s early discovery into high-quality clinical material, establishing the analytical and manufacturing foundations thatallowed the company to move from lead identification to first-in-human studies in just one year, an extraordinary pace in the mid-2000s. “That speed was unheard of back then,” Hood recalls.

Fedratinib went on to achieve impressive response rates in myelofibrosis, offering new hope to patients who had failed previous treatments. When regulatory uncertainty temporarily halted its progress, Hood never lost faith in the science or in the partner who had helped him realize it the first time.

At Impact Biomedicines, the situation was urgent, and the stakes were high. The company had an ambitious goal: manufacture three registration-grade lots of fedratinib within fourteen months. WuXi AppTec took on the challenge and delivered ahead of schedule. “That reliability was the difference between success and failure,” Hood says.“They gave us quality and speed at a scale no one else could match.”

In 2019, fedratinib won global approval. For Hood, the moment wasn’t just a professional triumph; it was the closure of a deeply personal circle. The patients who had once been left waiting now had a therapy in their hands.

The Next Frontier: Reversing the Irreversible

If fedratinib was about bringing back a lost medicine, Hood’s next venture is about rewriting what medicine itself can do. The company’s lead focus is idiopathic pulmonary fibrosis (IPF), a disease that scars the lungs until patients can no longer breathe. Current treatments can only slow the decline; none have yet reversed it.

Endeavor’s approach is built around a molecule that targets the Hedgehog signaling pathway, which regulates cellular repair. In a Phase 2a study, the compound showed something unprecedented: measurable reversal of fibrosis in the lungs. “That hasn’t been seen before,” Hood says. “To watch lung function and architecture improve over twelve weeks, it gives us hope that IPF may not have to be a death sentence.” Recently, this drug candidate became the first investigational IPF therapy to receive PRIME designation from the European Medicines Agency.

Behind that data was a quiet race against time. The material inherited from a prior license was nearing expiration, jeopardizing the trial schedule. WuXi AppTec and Endeavor’s teams worked side by side to design a new parallel synthesis process that not only replaced the old supply but improved yield and purity, allowing the Phase 2 trial to start on schedule. “Time is the biggest asset in our business,” Hood notes.“WuXi AppTec delivered drug product on time and at high quality. They’ve been a trusted partner for me going on two decades.”

The global study now spans four continents and more than a dozen countries, reflecting the complexity of modern development and the necessity of reliable partners who can bridge geographies and regulatory systems seamlessly. For patients whose lungs are failing, every week gained matters.

Engineering Precision Through Partnership

While one arm of Endeavor Biomedicines focuses on reversing lung fibrosis, the other is pushing boundaries in oncology. Its antibody–drug conjugate (ADC) program targets a receptor more prevalent than HER2, offering new possibilities for cancers that remain resistant to existing therapies. Yet behind this scientific ambition lay a practical obstacle: cost and complexity. ADC manufacturing involves dozens of interdependent steps, and even small inefficiencies can make a promising therapy unfeasible.

That’s where WuXi AppTec came in. Endeavor’s internal chemists worked closely with WuXi AppTec’s teams to redesign critical stages of the ADC synthesis. Together, they re-engineered the process to improve yield by more than 10 percent while simultaneously increasing purity and stability. “That improvement changed the economics of the project,” Hood says. “It turned something that might have been too expensive to pursue into a viable product candidate.”

For Hood, this experience captures what sets WuXi AppTec apart. “It’s about execution and innovation,” he says. “No matter what challenge arises, they find a way to deliver high-quality solutions fast.”

Source: 123RF

He puts it plainly: most partners will tell you that in drug development, you can pick only two out of three—speed, quality, or cost. “WuXi AppTec breaks that rule,” Hood said. “They consistently deliver all three at once; it’s a big reason I keep coming back.”

A Partnership Without Parallel

As Endeavor pushes forward with its Phase 2b trials and begins scaling its oncology program, Hood remains characteristically focused on the work still ahead. Yet when asked what these twenty years of collaboration mean to him personally, his answer comes easily.

“Any time you can get a new drug approved, that’s the pinnacle of a career,” he says. “WuXi AppTec supported us both in the discovery and registrational phases of fedratinib. Now they’re helping us pursue something just as meaningful in IPF and cancer. Throughout all this, they’ve been the one constant. With complex global trials, there’s plenty to worry about, but CMC isn’t one of them.”

Then he pauses, the way someone does when reflecting on a truth that’s self-evident. “I was fortunate to partner with WuXi AppTec early in my career,” he says finally. “And every time I’ve looked elsewhere, I’ve been reminded why. I simply can’t imagine working with anyone else.”

免責(zé)聲明：本文 僅作信息交流之目的，文中觀點(diǎn)不代表藥明康德立場(chǎng)，亦不代表藥明康德支持或反對(duì)文中觀點(diǎn)。本文也不是治療方案推薦。如需獲得治療 方案指導(dǎo)，請(qǐng)前往正規(guī)醫(yī)院就診。

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