汪有初博士：用速度與質量的“結晶”，換客戶的“省心” | 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。

10月的歐洲，天空湛藍，秋葉斑斕，柚子般金黃的陽光在屋頂灑下絲絲暖意。

在這個象征著豐收的季節，藥明康德高級副總裁、小分子原料藥早期項目業務部負責人——汪有初博士在歐洲出差訪問期間，也收獲了來自新老客戶們的贊許：

“藥明康德的賦能服務總是讓人省心、放心。經常是還沒等我們開口，你們就知道怎么做了。”

對于在藥明康德工作17年的汪有初博士而言，這些暖心的反饋已成為常態，也化為了他與團隊持續追求卓越、超越預期的不竭動力。

無論行業如何變化，他確信的一個事實是——團隊的行動的確比大家預想的還要“早”、還要“快”。

這種速度，從來不是靠急先鋒式的“盲目沖鋒”，而是靠早早地磨練團隊在各方面的專業能力、蓄勢待發，再在每一次項目開始前縝密規劃，從而穩穩立足于浪潮前沿。在藥明康德25年的發展歷程中，客戶第一，加速創新與突破，推動更多新藥、好藥早日造福全球病患，也是不變的堅持。

“不只是科學，更是藝術”

汪有初博士回憶，2008年剛加入時，全球創新藥項目的分子結構正變得越來越復雜、化學合成難度越來越大。為更好地滿足客戶需求，公司正在持續建設標準更高、能力更全面的一體化平臺，對原料藥工藝的開發與規模化生產也在進行技術升級、產能擴大與綜合能力的完善。

這些工作看起來是一脈相承，實際上卻是天差地別：從臨床前研究到臨床階段，所需的原料藥規模將從克級上升到公斤、乃至百公斤級，增加了好幾個數量級。

而大約90%的原料藥都是以固體形式生產出來的，晶體是其主要形式。

早期的結晶工藝做得好不好，將影響原料藥的純度、穩定性、溶解度和生物利用度等，從而影響著其安全性與有效性。而這些，都與產品交付的質量息息相關。

讓原料藥析出結晶的過程可謂“如履薄冰”，稍有不慎便會失敗。

即使在實驗室里成功了，如何通過科學合理的設計、在工廠里重復生產出大量滿足質量要求的晶型，仍然是一道橫亙在行業早期開發人員面前的難關。

2009年前后，為打破這一瓶頸，汪有初博士成立了一個專門的原料藥結晶小組。

從一開始，汪有初博士就向團隊強調：要用工藝開發人員獨有的思維模式，去思考項目應該怎么做。

從縝密地設計合成路線，到每一步操作都要規范、謹慎、嚴密，再到將結晶、純度與雜質控制在恰到好處的水平，才能得出可用于大規模工業化生產的路徑。

正如業界口口相傳的那句話：“結晶工藝不只是科學，更是一門藝術。”

“工”、“藝”二字，既包含著工匠般的精密有序，也包含著藝術家一般的極致追求。

在系統化的培訓之下，短短1年內，團隊就在工藝開發思維與操作技術方面有了大幅提升。而剛剛出師的團隊，很快就迎來了一場實際挑戰。

有一家生物醫藥公司找到藥明康德，開發一款新藥。項目正在關鍵階段、工廠急需晶種投產。但仿佛像是故意和科學家搗亂似的，這款分子遲遲不肯析出團隊所期待的晶型。

眼看著生產鏈即將中斷，汪有初博士親自走進實驗室做晶種，帶領團隊一步步從稱量到過濾干燥，全程排查問題，終于在截止時間到來之前，得到了達標的晶種，并交付工廠進行后續生產。

事后分析，這款分子對結晶環境有著異乎尋常的高要求。即便是最小的波動，也足以影響晶種的形成。

后來，這個案例成了汪有初博士培訓團隊的經典案例，他常常向大家強調，細節決定成敗，“做實驗一定要嚴格精準地控制每一步。”

再后來，在藥明康德的賦能服務下，這款新藥順利獲批上市。而有了這次共同挑戰難關的經歷，這家公司如今仍然保持著與藥明康德的合作，多款候選療法取得積極進展，其中一個早期項目近期贏得了一家大型藥企的青睞，還有數款產品已走出實驗室、來到患者身邊。

如今，隨著公司小分子業務的不斷發展，結晶組也從當初的“精銳小隊”發展成了扎根于各個核心基地的標準化力量。僅在2024年，公司的結晶團隊就支持了800多個化合物的工藝開發，其中包括190步的后期和商業化結晶工藝開發。

“第一次就把事情做對”

在工作中，汪有初博士常常對團隊講的一句話是：

“真正的‘快’，并不是讓大家匆匆忙忙開始行動。我們提速的關鍵在于，第一次就要把事情做對。”

“一次做對”，這句話乍一聽，似乎與只追求表面速度的“一步登天”形似。但細細揣摩就會發現，二者其實是截然相反的心態。

做過實驗的人都知道，真正限制實驗速度的，是犯錯與重做。

如果實驗沒想清楚，就為了提高速度而“搶跑”，往往容易出錯。而且并不像“做菜時多放了幾勺鹽”那么簡單，這些錯誤往往無法補救，只能推倒重來，之前的汗水也付諸東流。

更重要的，這會嚴重影響客戶的計劃，也會影響到患者用上新藥的時間。

要想第一次就到位，必須“磨出一把好刀”——先前瞻性地設計好路線與方法，對流程中的關鍵節點進行預判與周密部署，然后再開始行動，同時實驗過程中每一步還要做到精準控制。

或許剛開始，“三思而后行”看起來沒那么快，但它能讓整個項目運行得更順暢，終究是“磨刀不誤砍柴工”。

在這樣的思路下，團隊真正做到了“既保證質量，又大大提高了速度”。

汪有初博士透露，團隊完成一步工藝開發和生產的周期，已經從十年前的4-5周縮短到了現在的1-3周。由于這些工藝簡潔而高效，工廠用“同款”工藝生產出的產品質量也穩定。

這似乎再次佐證了客戶的感受——“讓人省心、放心”，并不是一飛沖天，而是各個團隊穩扎穩打、從量變到質變的結果。

汪有初博士表示，這種對質量和速度的追求，也如同一顆“晶種”，在藥明康德小分子原料藥和制劑的一體化CMC平臺的各個團隊生長、壯大。自25年前公司成立開始，為了更好助力全球合作伙伴加速新藥研發，藥明康德始終不懈推動工藝創新、卓越執行。除了結晶工藝的開發，在酶生物催化、金屬催化、連續化生產（流體化學）等專業性極強的原料藥工藝賦能技術平臺方面，也同樣建立起高標準、嚴要求的體系，為行業提供穩定可靠的工藝支持。目前，在各個專業團隊的合作下，小分子藥物D端（開發端）交付的原料藥產品與最初設計的質量指標相比，偏差率已降至極低水平。

圖片來源：123RF

提前半年“鋪路”

25年來，質量與速度的雙管齊下，鑄就了客戶對藥明康德的信賴。而端到端、一體化的CRDMO平臺帶來的穩定、全面的能力，讓之前尚未與藥明康德合作的一些客戶，也紛紛“路轉粉”，變為了“回頭客”。

汪有初博士還記得，去年圣誕節，他曾在微信上收到一位客戶的節日問候，但隨之而來的是焦急的求助信息。

那是一個此前合作過的客戶，客戶當時任職的生物技術公司，在其他CDMO平臺上的一個項目陷入了僵局。

盡管還過著圣誕，這位客戶仍在為此事發愁。左思右想，索性輾轉回來，重新聯系了汪有初博士。

急客戶所急，汪有初博士和團隊科學家們果斷迎難而上。項目確實非常復雜，但依賴10多年來締造的能力平臺，團隊很快便解決了這個大難題，給客戶送上定心丸。

而讓客戶更為欣喜的，是藥明康德“先人一步”的思考。

當時，項目還在早期開發階段，但汪有初博士在項目進行的過程中，就為客戶引薦了小分子原料藥的后期和商業化團隊，協助客戶提前布局。

果不其然，半年后，這一療法的臨床表現優異，快速推進到了后期。而先前與后期和商業化團隊的溝通，早已為環節之間的無縫銜接鋪墊好了關鍵的一步。

如今，一家大型藥企看中這款新藥的潛力，已將這家生物技術公司收入囊中。“收購完之后，項目還在我們這里接著做。”汪有初博士認為，這是對客戶創新能力的欣賞，也是對藥明康德一體化賦能服務的認可。

這樣的賦能服務，不僅是為客戶排憂解難、提供高效解決方案，更是一路助力客戶的科學創想“開花結果”、展現出真正的臨床價值，最終成為患者可及的新療法。

這樣的例子還有很多。

至2025年第三季度，小分子業務過去12個月內在D端支持了3350個臨床前到臨床3期的分子，同比增長2%；共80個分子處于商業化生產階段（M端），同比增長18%。

“很多客戶都曾和我說，非常認同我們這種早期和后期階段之間的無縫協作。”汪有初博士補充道。

拯救生命的心血結晶

這次采訪收尾時，歐洲正是清晨，天邊已泛起魚肚白，朝陽將要點亮整片天空。

汪有初博士笑著說，自己的名字代表著永遠要保“有”一顆“初”心。在藥明康德，這份初心就是公司成立25年來一直堅守的愿景——“讓天下沒有難做的藥，難治的病”。

幾個小時后，他將帶著這份初心，與新的客戶見面。新的一天，藥明康德的科學家們也將帶著這份初心開啟新的征程。

在這份始終如一的初心的守護下，25年來，一批批滿足客戶需求的藥物“結晶”正持續從藥明康德的實驗室走向工廠、醫院與病患。結晶中折射出的美麗光芒，也將載著一份份拯救生命的希望，奔赴遠方。

Building Before the Need

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.

“Yesterday I had a conversation with a client.” Dr. Youchu Wang, Senior Vice President and Head of API Early Phase Development at WuXi AppTec, says. The client hadn’t called to discuss a contract or a particular issue. “Your team is exceptional,” they told him. “You’re professional, you’re fast, you know what needs to be done before I even ask.”

He smiled: “After so many years in this business, I can say with confidence, we really do move faster than most.”

For him, that quiet speed defines the rhythm of his past 17 years of work at WuXi AppTec.

Building Capability Before the Need

WuXi AppTec’s evolution from early chemistry synthesis to a fully integrated CRDMO reframed the central challenge: translating lab reactions into robust, scalable manufacturing processes. That gap, between the flask and the reactor, is where capability emerges, where teams either improvise or execute by design.

From the outset, Wang has emphasized a distinct mindset, thinking like a process developer. That means mapping synthetic routes with intent, running process R&D with discipline, operating and optimizing equipment deliberately, and drawing conclusions that hold up at scale.

One episode captures this philosophy. The crystallization of a program’s final product began to encounter difficulties: seed crystals refused to form correctly, and the plant was waiting. Wang stepped into the lab himself, repeated the sequence, and produced the correct seed crystals. The root cause turned out to be deceptively subtle: moisture sensitivity. The team re-engineered the operation to isolate every step from air exposure, locked in the crystal form, and delivered the seeds on time. Today, Wang uses this case as a reminder that precision and respect for process are not merely words; they are habits built through daily practice.

That discipline quickly spread across teams. As the number of projects increased, WuXi AppTec paired practical, hands-on work with structured training, helping frontline managers think like developers. The results were clear: operations became smoother, and problems at manufacturing sites almost disappeared.

Much of this capability, Wang noted, was built long before the market demanded it. Clients often remark that WuXi AppTec’s platforms feel years ahead: technologies developed a decade earlier, ready for when the industry caught up. For many new partners, that foresight is what convinces them to collaborate. They’re not merely choosing speed; they’re joining a system engineered in advance to make speed reliable.

Doing it Right the First Time

As WuXi AppTec’s capabilities grew, the focus naturally shifted from building them to proving how they perform under real pressure. The company’s expertise in chemistry and process development became its foundation. The real test was whether that foundation could deliver consistent speed, solve problems effectively, and earn lasting trust from clients.

“True speed,” Wang says, “isn’t about going fast; it’s about getting it right the first time.” Rushing only leads to rework, and rework slows everything down. What really keeps projects moving is foresight: a well-thought-out method, a clear plan everyone can follow, and an initial experiment that produces results you can build on.

That philosophy shows up in everyday work. Processes are designed to reduce variation, and handoffs are practiced to prevent bottlenecks. Early planning may seem slow at first, but it makes the whole project run more smoothly. “Speed,” Wang says, “is what quality looks like over time.” It’s not about chasing deadlines; it’s about removing the causes of delay.

The results speak quietly but clearly. The cycle to complete one step of chemical process development and manufacture that once took four to five weeks now finishes in one to two weeks, three at most. Quality deviations are kept to an absolute minimum, a level clients see as proof rather than promise. In manufacturing terms, precision is the engine, and speed follows naturally.

This same disciplined system matters most when projects become complex. Many clients turn to Wang’s team when a program elsewhere has stalled. “In one case,” Wang recalled, “we took over a project that had completely stalled. Within two months, we reset the process and delivered clean results.” Later, the client wrote to thank the team: “Your speed, your quality, and your technical capability made everything smoother and easier for us.”

For Wang, that is the real meaning of speed, not haste, but the ability to move decisively through complexity, to identify what matters, and to make things work when others cannot.

Integration and the Culture That Powers It

If speed is earned through foresight and precision, integration is how that steadiness appears in daily operations. The same discipline that prevents rework also prevents friction between teams. At WuXi AppTec, early- and late-stage programs start aligning months in advance, so handoffs feel less like transfers and more like continuities. Clients, especially smaller or resource-limited biotech companies, see the difference in their schedules and risk profiles: fewer surprises, clearer communication, steadier progress.

One example came from a client who reached out during Christmas week. The program, complex and underperforming elsewhere, was transferred to WuXi AppTec. An early-stage team restarted the work, while late-stage leaders met the client six months before formal transition to align expectations. By the time the handover came, most of the uncertainties had already been resolved. The process continued without interruption, and soon after, the biotech was acquired by a major pharmaceutical company, a reminder that operational continuity can lead to strategic opportunity.

“We are still supporting the program after the acquisition.” Wang adds.

The result is a platform that meets projects where they are and carries them forward without breaking stride. It’s not about claiming perfection; it’s about doing the small, predictable things ensuring that the science keeps moving even as the work changes hands.

On the Road Again

As the call drew to a close, the hum of transit returned. Wang was already between meetings, preparing for the next stop. As he spoke, his tone turned reflective.

“What we’re really building,” he says, “is a strong capability and technology platform, one that enables our partners to develop new drugs both quickly and with high quality, meeting their needs while advancing our broader vision.”

Since joining the company, Wang has seen WuXi AppTec evolve alongside the industry, continually improving and optimizing toward today’s integrated CRDMO model. “We’ve been changing since the beginning,” he noted, “but our focus remains the same: helping move projects toward the market so that people and patients can access better medicines.”

The line went quiet. Somewhere on the road in Europe, Wang continued his trip with the same conviction that shapes his work every day: capability built ahead of need, precision practiced without pause, and a belief that every drug can be made and every disease can be treated.

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