35天化解“危機”；搶出數月上市時間——“藥明速度”的背后是什么？ | 逐夢者說 | Bilingual

編者按：“讓天下沒有難做的藥，難治的病”，是初心，更是愿景。二十五年來，藥明康德步履不停：從一間實驗室，到覆蓋亞洲、歐洲和北美的全球網絡。從早期的化學合成服務，到貫穿研究（R）、開發（D）和生產（M）的一體化平臺。從第一位客戶，到全球三十多個國家的數千合作伙伴。不斷發展的，是規模與能力；始終堅守的，是夢想與承諾。

致敬來時路，共譜新篇章！在二十五周年之際，我們以“逐夢者”視角，回顧藥明康德成長發展的崢嶸歲月，回望賦能客戶創新的并肩往事，更以獨特的“藥明精神”展望未來新篇章。

去年夏天，傅小勇博士迎來了一位老朋友的訪問。

多年前，這位老朋友還是一家初創公司的高管，就一款抗癌新藥與藥明康德子公司合全藥業展開合作。

合全藥業團隊從該藥物的第一個生產批次做起，一直支持到了這款藥物商業化階段生產，完成全周期的閉環。

最終，藥物成功推向市場，成為一款延長無數癌癥患者生命的“重磅炸彈”。這家初創公司也被一家大型藥企收購，迎來新的發展篇章。

再次見到傅小勇博士，這名高管難掩激動：“小勇，之前的抗癌藥，你們將上市時間提前了數月，成千上萬的患者因此可以更早地獲得治療。”

如今，這位曾經的合作伙伴已經創立新公司，為患者開發全新藥物。他也決定在新的征程中再次與藥明康德攜手并進——“無論外部環境如何變化，我們新公司的每一款產品，都將繼續使用藥明康德的服務。”這名高管說道。

對傅小勇博士而言，他又一次深切體會到“藥明速度”對客戶、對患者的深遠影響。對于合作伙伴投以的信任，他深表感激。

這個案例，是藥明康德二十五年來以一體化CRDMO模式賦能新藥研發，贏得客戶信任的一個縮影。

一體化平臺，推動速度與質量“飛輪”

2012年，傅小勇博士成為藥明康德的一員，親歷了公司小分子CRDMO模式的發展與完善。從化學早期研發業務起步，藥明康德逐漸打通了早期發現（R）、工藝開發（D）到商業化生產（M）的全鏈條。

作為藥明康德化學業務的重要組成部分，合全藥業多年來快速發展，已在亞洲、北美及歐洲地區設立研發及生產基地，為全球合作伙伴提供從小分子原料藥到制劑的一體化賦能。

如今，作為藥明康德執行副總裁、合全藥業負責人，傅小勇博士正在帶領團隊，以“藥明速度”支持全球合作伙伴，將一款款小分子新藥加速推向市場，給無數患者帶來新生。

數據是最好的證明。根據公開數據，2024年初到2025年上半年期間，在美國FDA批準的40款小分子新藥中，藥明康德支持了其中的8款。

藥明康德是如何做到的？

面對這個問題，傅小勇博士語氣堅定：“我們能在高質量標準下，以極高的執行速度為客戶提供服務。”

在醫藥行業深耕幾十年，傅小勇博士見過太多“速度決定成敗”的案例。

創新藥研發總是在與時間賽跑。“有時早啟動臨床一個月，可能就意味著未來上市時間提前一年甚至數年。”

對于醫藥企業，速度意味著可以更快將新藥推向市場，更早將資源投入后續研發，形成創新的良性循環。

對于患者，新藥問世的速度更是直接決定了有多少患者能盡早控制病情，乃至挽救生命。

文章開頭的抗癌藥故事，正是“藥明速度”助力眾多新藥提前上市的一個縮影。

體現藥明康德能力的另一個關鍵詞是質量。

“公司高水平的全球質量體系是基石，這使我們能夠滿足全球監管機構的嚴格要求。”傅小勇博士充滿底氣。

二十五年來，藥明康德持之以恒地建立起了覆蓋新藥研發全生命周期的質量體系。

數據顯示，2009年以來，藥明康德化學業務平臺成功通過全球監管機構的審計超過140次。得益于出色的質量記錄，25次新藥上市批準前檢查（PAI，Pre-Approval Inspection）獲得美國FDA和EMA豁免。

嚴格的質量管理不僅讓客戶感到安心，同時也反哺了速度優勢。

在很多人的直覺中，質量與速度似乎是一對矛盾體。但在新藥的工藝開發和生產領域，邏輯則完全不同。

對此，傅小勇博士以第一批放大生產為例解釋：當工藝從實驗室轉移到工廠時，溫度、設備性能等一系列因素的變化可能導致批次失敗，而失敗可能意味著數周甚至數月的返工，以及大量材料損失。從實驗室到生產工廠，高質量的“一次性成功”對客戶而言至關重要。

只有確保了質量，速度才能真正轉變為更快的項目進度。

而將速度與質量完美銜接在一起的，正是藥明康德的一體化平臺優勢。

傅小勇博士描述了一個場景：如果客戶委托供應商A生產原料藥，卻將制劑生產交給了供應商B。原料藥完成后，供應商B必須重新驗證材料、文件和方法。“整個交接過程可能耗時數周，更不用說過程中可能存在的其他風險。”

相比之下，藥明康德的一體化模式能夠在“同一屋檐下”執行不同環節，原料藥的很多質量體系與分析方法可以直接應用于制劑生產，縮短關鍵路徑的用時。

同時，在一體化平臺上，藥明康德的不同團隊能夠高效協調，從原料藥到制劑的工藝開發和生產各環節平行啟動、無縫銜接。例如在完成原料藥工藝開發并準備進行放大生產時，可以在放大批次生產之前，提前啟動少量樣品制備用于制劑工藝開發，提前啟動一系列實驗室研發工作，從而避免了流程間的時間延誤。

“這種一體化模式可以幫助客戶的項目提前1~2個月甚至更長時間進入臨床。”傅小勇博士解釋道。

修煉內功，應對小分子新挑戰

從業三十多年，傅小勇博士持續見證著小分子產業的發展趨勢和挑戰。

當前，小分子依然占據全球新藥研發管線的半壁江山。為了攻克更多疾病靶點，尤其是曾經“不可成藥”的靶點，小分子藥物的結構愈發復雜、分子量也持續增加。

過去，制藥行業內流行著一套評估小分子化合物成藥可能性的“里賓斯基五規則”（Lipinski's rule of five）。這套規則的第一條，就指出化合物的分子量應該小于500道爾頓，否則分子在體內的溶解度將大打折扣。

而數據顯示，過去5年，分子量超過600道爾頓的小分子比例增加了63%，合成步驟超過20步、甚至30~50步的復雜分子也逐漸增多。

這種分子復雜性的增加，對新藥工藝開發和生產的質量和效率提出了更高要求。

但在傅小勇博士看來，這恰恰是藥明康德更好地賦能合作伙伴的巨大機會。

原因很好理解。經過25年的發展和積累，藥明康德通過不斷理解創新趨勢和客戶需求，已提前布局、建立了解決復雜分子挑戰的全面的技術和能力。

例如，為提升復雜藥物分子的溶解度，合全藥業多年來打造了包括噴霧干燥、熱熔擠出、納米懸浮、液體膠囊、脂質納米顆粒等全方位的工藝技術平臺。

其中，噴霧干燥技術被業內普遍認為是提升復雜分子口服吸收效率最有效的手段。

在這一技術領域，從上海外高橋、到常州、泰興基地，合全藥業已經建立了從實驗室規模到商業化階段的全面噴霧干燥能力。在瑞士庫威基地，全新的噴霧干燥生產線也預計將于明年第四季度全面投入運營。

“即使在全球范圍內，也只有少數公司擁有如此大規模的噴霧干燥產能。”傅小勇博士提到。

不僅是噴霧干燥，合全藥業還在酶催化、連續化生產以及制劑新技術等領域不斷投入，更好地賦能全球客戶的新藥研發。

隨著平臺能力與產能的提升，藥明康德有能力解決更多客戶面臨的新挑戰，為更多復雜的新藥鋪平問世的道路。

傅小勇博士提到兩個案例。在一項合作中，一款復雜候選藥物分子的初始總收率低至幾十個PPM（parts per million）級別。換言之，在整個化學合成過程中，目標產物的產量微乎其微，僅有理論產量的百萬分之幾十。

即使是對于身經百戰的傅小勇博士而言，這也是他“從業幾十年來從未見過的化學挑戰”。

好在，藥明康德長期、全面的能力可以隨時應對挑戰。在合全藥業技術團隊與客戶合作重新設計合成路線后，難題最終被攻克。藥明康德已為客戶提供數百公斤的原料藥以支持臨床試驗，如今，公司正在進行更大規模生產，以支持這款分子未來潛在的商業化需求。

在另一個案例中，一位客戶發來緊急請求：一款已上市藥物因某一供應商生產批次的雜質問題，需要在短時間內解決問題。若不及時解決，眾多依賴這款藥物的患者將面臨“斷供”的困境。

患者的生命不是兒戲。接到客戶需求后，合全藥業第一時間行動，多個團隊高效協作，開發、驗證了新的分析方法，并生產出了客戶需要的大量原料，最終為客戶化解了危機。

完成這一切，藥明康德僅僅用了35天。

廿五載堅守，回應生命期許

在藥明康德，這樣的故事“太多了”，傅小勇博士如是說。面對客戶的需求，“我們不僅要有挺身而出的擔當，更要有解決問題的能力。”

這正是藥明康德成立25年來，每一天的使命所在。“我們要不斷為客戶做對的事，并且把事做好。”他補充道。

作為從業幾十年的科學家和企業管理者，傅小勇博士見過那些無藥可用的遺憾，也理解每個病患對生機的渴望。他深有體會的是，藥物研發不只是科學，不只是數字，而是對生命的回應。這也是“讓天下沒有難做的藥，難治的病”這一愿景的具象。

“不管分子有多復雜，不管挑戰有多艱難，我們會繼續提供高質量、高效的服務，助力全球合作伙伴將創新科學盡快變為創新療法，為患者造福。”

Building Trust Through Integration

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.

During a routine meeting, the CEO leaned across the table and said quietly,

“Xiaoyong, you may not realize it, but you helped us launch our cancer drug several months ahead of schedule. It was just months ahead, but it meant thousands of patients started treatment sooner.”

Dr. Xiaoyong Fu remembers the moment vividly. Years have passed since his team at WuXi STA had guided that program from first batch to blockbuster. That company has since been acquired, yet its leaders, now building a new biotech, returned to tour WuXi AppTec sites, walking the same production floors where the drug had first taken shape. “They told me that no matter how the world changes, every product from their new company will be developed with WuXi STA,” Fu recalls. “That is the highest form of trust we can earn.”

Speed with Quality

WuXi STA is WuXi AppTec’s global small-molecule CDMO platform, spanning Asia, Europe, and North America. Its integrated model links Development and Manufacturing within a single Operating System, so molecules can move seamlessly from idea to medicine. APIs and drug products are developed under one quality framework, with analytical methods and safety assessments connected like cogs in a well-tuned machine.

For Dr. Xiaoyong Fu, the executive vice president of WuXi AppTec, and head of WuXi STA, the work is a responsibility: “Our guiding principle is to deliver every project at the highest quality and the fastest speed possible, so our clients gain the greatest benefit.”

That benefit is twofold. Socially, the faster a program advances, the sooner it reaches the clinic, proves itself in human, and becomes a therapy for patients. Even a single day matters, let alone weeks or months. Economically, earlier market entry helps clients recover R&D costs sooner and reinvest earlier, creating a virtuous cycle that brings more medicines to patients in the future.

Speed, however, is not haste. “It’s precision, orchestration, and the discipline to deliver faster without ever lowering the bar,” Fu explains. Consider the first scale-up batch: when a process moves from lab to plant, temperature, mixing, and equipment behavior change dramatically. A failed first batch can mean weeks or months of rework, lost material, and delay. “From lab to plant, that ‘first-time-right’ execution is what matters most to our clients.”

The solution is systemic. During scale-up, tightly coordinated teams move as one. The R&D scientists who developed the process are on site for initial production runs, resolving issues before they escalate. Plant engineers partner closely with R&D to ensure smooth execution. A central planning team coordinates which projects run in which reactors, keeping every program on schedule and safe.

“That’s how we ensure every project proceeds smoothly, efficiently, and without surprises.” Fu says.

The Power of Integration

The first scale-up batch is only one facet of WuXi STA’s integrated system. Process R&D, including formulation process development, is inherently complex. It’s not something that a small team can accomplish alone.

Consider a common scenario: a client asks WuXi STA to make the API but sends formulation to another vendor. Once the API is finished, materials, documents, and methods must be requalified. That handoff can add weeks. “When we finalize an API process and prepare for scale-up plant batch, we typically run a demo batch in lab and prepare representative API material for formulation process development, and launch a series of laboratory DP R&D work in advance,” Fu says. “Without integration, there can be a month or more of idle time between those steps.”

On the other hand, under WuXi STA’s unified quality system, many API analytical methods can be adapted directly for drug-product work, accelerating the downstream development and shaving time from the critical path. Just as important, a dedicated project management team acts as the bridge between internal operations and clients. “Each molecule involves many complex steps during execution,” Fu notes. “If we asked clients to coordinate every detail, it would be overwhelming.” The project management team streamlines the process by connecting every department and discipline, ensuring clear communication and seamless collaboration.

That end-to-end continuity from API to formulation can save one to two months, and in some cases even more.

“For any company aiming for first-in-human, starting a month or more earlier creates tremendous value,” Fu adds. “Our efficiency and integration translate directly into faster progress and greater success for our clients.”

Meet the Challenges

Fu has lived the evolution of modern drug development. Over 30 years in the field have shown him how small molecules have grown ever more intricate, many now exceeding 500 Daltons, defying “Lipinski's Rule of Five,” or other dogmas about what makes a drug “druggable.”

“The easy molecules are gone,” he says, “Today’s molecules are heavier, more complex, and harder to synthesize. But that’s where our strength lies, making the complex possible, and making it fast.”

For example, due to the increasing molecular size and complexity of modern compounds, some molecules have poor bioavailability when developing oral formulations such as tablets or capsules, meaning the compound is barely absorbed in the body.

To meet this challenge and help clients advance better drugs, WuXi STA has invested in spray-drying technology, a proven approach to enhance bioavailability for low-solubility compounds. The company’s global sites offer capabilities from lab scale to commercial scale; at Couvet, Switzerland, a new five-story facility has been completed to house PSD4 equipment, with the spray-drying line expected to be fully operational in early Q4 next year.

“Globally, only a few CDMOs possess such large-scale spray-drying capacity,” Fu notes.

As the platform’s capabilities and capacity improve daily, WuXi STA is serving more clients and solving newer challenges. In one case, a partner’s complex candidate began with an overall yield as low as a few dozen parts per million (PPM), “something I’d never seen in decades of chemistry,” Fu says. After teaming up with the client to redesign the route, WuXi STA has since supplied hundreds of kilograms of API to support clinical trials, and is now scaling up to meet the molecule’s potential commercial demand.

In another urgent case, a marketed therapy faced a potential supply halt due to an impurity issue. Within 35 days, WuXi STA developed a process to reject the impurity and verified new analytical methods and produced compliant material at scale to avert the shortage.

“If we hadn’t delivered on time, patients would have faced a shortage,” Fu says. “That’s when you realize our work isn’t just about chemistry; it’s about continuity of care.”

Trust, Translated into Chemistry

From saving programs on the brink of regulatory rejection to enabling first-in-class molecules to reach the clinic, WuXi STA’s work is defined by one throughline: trust.

Fu often cites a company credo: “Doing the Right Thing, Doing It Right.”

“That’s what our clients see in us,” he says. “No matter the molecule, no matter the challenge, we deliver with quality, with speed, and with purpose. That’s how we turn science into impact.”

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