編者按：肺癌是全球發(fā)病率和死亡率最高的癌癥之一，晚期肺癌患者整體5年生存率在20%左右。其中非小細(xì)胞肺癌（NSCLC）是最常見(jiàn)的病理類型，約占肺癌的85%，70%以上的患者確診時(shí)已處晚期，傳統(tǒng)治療效果不佳。近20年，產(chǎn)業(yè)界逐漸發(fā)現(xiàn)，不少非小細(xì)胞肺癌患者攜帶特定的變異基因，比如

EGFR

ALK

KRAS

MET

RET

BRAF

等，對(duì)應(yīng)的靶向治療藥物也應(yīng)運(yùn)而生，讓不少晚期患者也有望獲得腫瘤明顯退縮、生存期大幅延長(zhǎng)的機(jī)會(huì)。這些年隨著產(chǎn)業(yè)界的不懈努力，肺癌靶向療法領(lǐng)域有越來(lái)越多新療法相繼問(wèn)世，研發(fā)投入和管線也在持續(xù)增長(zhǎng)，為患者帶來(lái)新的希望。長(zhǎng)期以來(lái)，藥明康德也一直通過(guò)為合作伙伴提供“一體化、端到端”的CRDMO賦能服務(wù)，助力肺癌療法等新藥的開(kāi)發(fā)，為更多患者點(diǎn)燃生命之光。今天，讓我們一起來(lái)了解一款RET抑制劑改變晚期肺癌患者生命軌跡的故事。

咳嗽8年查出肺癌，手術(shù)加化療1年后就發(fā)生肝、腦轉(zhuǎn)移

伊拉娜·斯特龍伯格（Ilana Stromberg）來(lái)自美國(guó)得克薩斯州，是5個(gè)孩子的媽媽。一直以來(lái)，她過(guò)著健康而快樂(lè)的生活，經(jīng)常參加本地社區(qū)活動(dòng)，還不時(shí)和家人去戶外運(yùn)動(dòng)。在她珍藏的家庭錄影里，她曾在金色沙灘上看孩子們追逐嬉戲，在銀色雪地上乘著雪橇歡快前行，在山巒環(huán)抱的溪谷中聆聽(tīng)流水潺潺，在幽靜的林間與家人盡情歌唱……

圖片來(lái)源：123RF

可天有不測(cè)風(fēng)云，2019年，一紙?jiān)\斷報(bào)告給她的世界罩上了陰霾——經(jīng)過(guò)持續(xù)8年的慢性咳嗽后，52歲的她被確診為II期非小細(xì)胞肺癌。

伊拉娜表示，自從44歲時(shí)懷上雙胞胎女兒，她就開(kāi)始經(jīng)?？人?，但當(dāng)時(shí)以為只是孕期正常的不適反應(yīng)。結(jié)果生完孩子后，咳嗽并沒(méi)有消失。后來(lái)她又多次去醫(yī)院檢查，都沒(méi)查出真正的病因，直到這次確診為肺癌。

確診后幾周內(nèi)，醫(yī)生為她進(jìn)行了手術(shù)，切除了20%的右肺，手術(shù)很順利，術(shù)后恢復(fù)得也很好。但同時(shí)，醫(yī)生在術(shù)中發(fā)現(xiàn)了2個(gè)淋巴結(jié)轉(zhuǎn)移，因此建議術(shù)后化療?；熎陂g，她一直堅(jiān)強(qiáng)而樂(lè)觀。完成化療后，前3次的復(fù)查結(jié)果都顯示“疾病穩(wěn)定”?？祻?fù)期間，她幾乎每天都跑步和鍛煉，并保持健康飲食。

圖片來(lái)源：123RF

不幸的是，化療后1年的復(fù)查結(jié)果亮起了紅燈——癌細(xì)胞已經(jīng)擴(kuò)散到了肝臟，也就是進(jìn)入了晚期（轉(zhuǎn)移性）肺癌階段。她不得不進(jìn)行肝臟手術(shù)，切除了50%-60%的肝臟。

就在她以為終于可以喘口氣時(shí)，腦部掃描結(jié)果又帶來(lái)雪上加霜的一擊——當(dāng)聽(tīng)到“腦轉(zhuǎn)移”幾個(gè)字時(shí)，伊拉娜一時(shí)陷入了暗無(wú)天日般的絕望。針對(duì)這個(gè)孤立的腦轉(zhuǎn)移病灶，醫(yī)生又為她進(jìn)行了伽馬刀放射治療。

但此時(shí)的伊拉娜顯然有些泄氣，她在疾病早期就得到了確診，還進(jìn)行了及時(shí)、積極的治療，整個(gè)抗癌過(guò)程都相當(dāng)努力，命運(yùn)卻一次次將自己推向更深的深淵。

患病后，她有很長(zhǎng)一段時(shí)間無(wú)法去戶外活動(dòng)，院里的花草也因疏于照顧枯萎了。丈夫的事業(yè)非常忙碌，只能盡量抽空陪陪她。盡管經(jīng)常疲勞、時(shí)不時(shí)犯惡心、多次差點(diǎn)暈倒，但她堅(jiān)持每天早起，給3個(gè)還在上學(xué)的孩子準(zhǔn)備早餐和要帶去學(xué)校的午餐便當(dāng)，再去醫(yī)院做治療。孩子們只知道“媽媽病了”，但并不知道有多嚴(yán)重。只有丈夫知道，每晚等孩子們?nèi)胨螅晾葧?huì)在房間里和丈夫相擁而泣，讓壓抑已久的情緒得到暫時(shí)的釋放。

圖片來(lái)源：123RF

“我聽(tīng)說(shuō)，像我這種的情況生存率是相當(dāng)?shù)偷?。雖然身邊的人愛(ài)著我，我也愛(ài)著他們，但我隨時(shí)可能離開(kāi)他們，孤獨(dú)地面對(duì)死亡。我曾想過(guò)要見(jiàn)證孩子們的畢業(yè)典禮、婚禮，還想過(guò)以后可以含飴弄孫……可現(xiàn)在，我甚至不知道自己還能活幾個(gè)月。下次孩子們上臺(tái)表演、上球場(chǎng)比賽那天，我還會(huì)陪在他們身邊嗎？以后他們難過(guò)時(shí)，再也沒(méi)有誰(shuí)能給他們媽媽般的溫暖抱慰……”

新型靶向藥帶來(lái)轉(zhuǎn)機(jī)

正當(dāng)伊拉娜覺(jué)得前路無(wú)望時(shí)，她的命運(yùn)迎來(lái)了轉(zhuǎn)機(jī)——在一位朋友的提議下，她決定去做肺癌的分子分型檢測(cè)。如果查出攜帶特殊的突變基因，或許就能用上針對(duì)這種突變的靶向藥物，而此前報(bào)道顯示，多款針對(duì)突變基因的靶向藥都表現(xiàn)出相當(dāng)驚艷的治療效果。

萬(wàn)幸的是，這次檢查還真有新發(fā)現(xiàn)——原來(lái)伊拉娜的腫瘤存在

RET

基因重排 。“也就是說(shuō)，我有機(jī)會(huì)嘗試一種叫做塞普替尼（selpercatinib，商品名：Retevmo）的新藥。”

圖片來(lái)源：123RF

伊拉娜了解到，

RET

基因融合是非小細(xì)胞肺癌的驅(qū)動(dòng)基因變異類型之一，約發(fā)生在1%-2%的非小細(xì)胞肺癌患者中，這類患者預(yù)后較差，傳統(tǒng)治療模式療效有限，易發(fā)生腦轉(zhuǎn)移，且腦轉(zhuǎn)移后的生存期僅為3-6個(gè)月。

RET

基因變異主要包括

RET

融合與

RET

激活性點(diǎn)突變，其中

RET

融合更常見(jiàn)于非小細(xì)胞肺癌和甲狀腺乳頭狀癌，而后者主要發(fā)生于甲狀腺髓樣癌。這類變異會(huì)導(dǎo)致 RET 信號(hào)通路異常激活、促進(jìn)癌細(xì)胞不受控制地增殖和生長(zhǎng)。

而塞普替尼作為高選擇性RET激酶抑制劑，能精準(zhǔn)抑制RET這一蛋白激酶的活性、幫助阻止癌細(xì)胞生長(zhǎng)，就像掐斷了給癌細(xì)胞發(fā)射“催生信號(hào)”的“天線”。

那時(shí)是2020年，恰逢塞普替尼剛獲美國(guó)FDA上市不久，當(dāng)時(shí)首次獲批的適應(yīng)癥包括2類：

• RET

  基因融合陽(yáng)性的局部晚期或轉(zhuǎn)移性非小細(xì)胞肺癌成人患者；

• 需要系統(tǒng)性治療的晚期或轉(zhuǎn)移性

  RET

  突變型甲狀腺髓樣癌成人及12歲以上兒童患者，以及需要系統(tǒng)性治療且放射性碘難治（如果放射性碘適用）的晚期或轉(zhuǎn)移性

  RET

  融合陽(yáng)性甲狀腺癌成人及12歲以上兒童患者。

服藥后，伊拉娜感覺(jué)病情的變化可以用“奇跡”來(lái)形容——這款新藥產(chǎn)生了很明顯的療效，甚至對(duì)腦部轉(zhuǎn)移病變也有效果。要知道，肺癌腦轉(zhuǎn)移是晚期肺癌患者中很常見(jiàn)的轉(zhuǎn)移瘤，而且很難用傳統(tǒng)方法治療。用藥1年后，外科醫(yī)生告訴她，多虧這款新藥讓腫瘤縮小，才讓她有機(jī)會(huì)再次進(jìn)行手術(shù)，后續(xù)也有了更多治療選擇。

如今，她恢復(fù)了更高質(zhì)量的生活，得以繼續(xù)享受久違的大自然的美好，享受與家人、朋友在一起的時(shí)光。

圖片來(lái)源：123RF

“以前，我總覺(jué)得‘一切都會(huì)好起來(lái)’只是句安慰人的空話?，F(xiàn)在我才發(fā)現(xiàn)，‘一切真的會(huì)好起來(lái)’。這段旅程中每前進(jìn)一步，我都能看到治愈的希望，這真是太神奇了。”伊拉娜感慨道，“感謝幸運(yùn)的眷顧，讓我查出了自己是

RET

基因變異陽(yáng)性，而且有藥可治。希望更多病友能了解基因檢測(cè)的重要性，也希望他們知道，世界上會(huì)有像塞普替尼這類靶向藥的存在，為我們帶來(lái)更多生存希望。”

讓60%-80%患者腫瘤縮小、超半數(shù)患者活過(guò)5年的新藥

據(jù)研發(fā)公司官網(wǎng)介紹，塞普替尼是首個(gè)被批準(zhǔn)專門用于治療攜帶RET基因變異的癌癥患者的精準(zhǔn)療法。2022年，美國(guó)FDA又加速批準(zhǔn)了塞普替尼的擴(kuò)展適應(yīng)癥，不局限于特定癌癥種類，可以廣泛用于接受前期系統(tǒng)性治療后疾病進(jìn)展或沒(méi)有其它滿意的替代治療選擇、且腫瘤存在

RET

基因融合的局部晚期或轉(zhuǎn)移性實(shí)體瘤患者。

2024年10月，中國(guó)患者也迎來(lái)了好消息——中國(guó)國(guó)家藥監(jiān)局（NMPA）批準(zhǔn)塞普替尼（商品名：睿妥）用于治療

RET

融合陽(yáng)性的局部晚期或轉(zhuǎn)移性非小細(xì)胞肺癌成人患者，同時(shí)獲批的還有

RET

基因變異的甲狀腺癌相關(guān)適應(yīng)癥。

支持其在美國(guó)和中國(guó)上市的關(guān)鍵臨床試驗(yàn)代號(hào)為“LIBRETTO-001”，在2024年歐洲肺癌大會(huì)（ELCC）上公布了最終分析結(jié)果：在247例之前接受過(guò)鉑類藥物化療的

RET

融合陽(yáng)性晚期非小細(xì)胞肺癌患者中，61.5%的患者獲得了客觀緩解（即腫瘤明顯縮?。形粺o(wú)進(jìn)展生存期為26.2個(gè)月，中位總生存期達(dá)47.6個(gè)月；69例初治患者中，獲得客觀緩解的患者比例更是高達(dá)82.6%，中位無(wú)進(jìn)展生存期為22個(gè)月，中位總生存期尚未達(dá)到，當(dāng)時(shí)已有超半數(shù)患者（52.3%）實(shí)現(xiàn)了超過(guò)5年的長(zhǎng)期生存。

此外，另一項(xiàng)代號(hào)為“LIBRETTO-431”的臨床試驗(yàn)顯示，在261例RET融合陽(yáng)性晚期非小細(xì)胞肺癌初治患者的一線治療中，相比化療聯(lián)合免疫治療，塞普替尼讓患者的中位無(wú)進(jìn)展生存期實(shí)現(xiàn)了翻倍（24.8個(gè)月 vs 11.2個(gè)月），疾病進(jìn)展或死亡風(fēng)險(xiǎn)顯著降低53.5%。這意味著，超半數(shù)初治患者能獲得2年以上病情穩(wěn)定的高質(zhì)量生存。而且作為口服藥物，它的使用比需要打針輸液的抗癌藥更加便捷，大大提升了患者的生活質(zhì)量。

圖片來(lái)源：123RF

產(chǎn)業(yè)界對(duì)塞普替尼的探索仍在繼續(xù)，期望進(jìn)一步擴(kuò)大適應(yīng)癥、造福更多患者。由于

RET

致癌基因變異發(fā)生在約2%的癌癥類型中，尤其是肺癌、甲狀腺髓樣癌、甲狀腺癌、直腸癌、乳腺癌、胰腺癌等，它已成為了“不限癌種”療法的重要靶點(diǎn)之一。目前有多項(xiàng)臨床試驗(yàn)正在進(jìn)行中，旨在探索塞普替尼治療

RET

變異的復(fù)發(fā)性非小細(xì)胞肺癌、淋巴瘤、中樞神經(jīng)系統(tǒng)腫瘤以及術(shù)前治療

RET

變異的甲狀腺癌等疾病的安全性和有效性。

近年在非小細(xì)胞肺癌靶向治療領(lǐng)域，不止RET這一個(gè)靶點(diǎn)取得了重大突破，其他靶點(diǎn)如EGFR、ALK、KRAS G12C、MET等也誕生了相當(dāng)多的創(chuàng)新藥物。每一款創(chuàng)新藥物的背后，都是無(wú)數(shù)科學(xué)家鍥而不舍的努力。過(guò)去20多年中，美國(guó)FDA共批準(zhǔn)了幾十款治療非小細(xì)胞肺癌的靶向療法，該領(lǐng)域目前還有900多款在研新藥正處于不同的臨床研究階段，涵蓋的靶點(diǎn)多達(dá)幾十種，有望造福更多罹患不同突變的病患。

長(zhǎng)期以來(lái)，藥明康德都在支持全球合作伙伴從藥物研究（R）、開(kāi)發(fā)（D）到商業(yè)化生產(chǎn)（M）各個(gè)階段的需求，通過(guò)獨(dú)特的一體化、端到端CRDMO模式，助力這類突破性療法加速研發(fā)進(jìn)程、早日惠及患者。

在早期研發(fā)階段，藥明康德可助力肺癌靶向藥物從藥物發(fā)現(xiàn)、CMC及制劑、藥理藥效、藥代毒理、IND申請(qǐng)到獲得臨床試驗(yàn)批件的全過(guò)程推進(jìn)。例如，針對(duì)腦轉(zhuǎn)移，藥明康德生物學(xué)業(yè)務(wù)平臺(tái)已建立多種肺癌腦轉(zhuǎn)移動(dòng)物模型，包括基于頸內(nèi)動(dòng)脈注射的模型，可更真實(shí)地模擬腫瘤細(xì)胞穿越血腦屏障的生物學(xué)過(guò)程，為藥物腦部療效評(píng)價(jià)提供堅(jiān)實(shí)基礎(chǔ)。

在后續(xù)開(kāi)發(fā)階段，藥明康德建立了全面的能力，構(gòu)建起了從科學(xué)探索到臨床轉(zhuǎn)化的加速路徑，顯著降低了合作伙伴的開(kāi)發(fā)周期，提高了研發(fā)效率。例如，藥明康德測(cè)試業(yè)務(wù)平臺(tái)可為合作伙伴提供全面、專業(yè)、系統(tǒng)的生物分析解決方案，助力合作伙伴的藥物成功申報(bào)IND、NDA和BLA。該平臺(tái)還能為合作伙伴的藥品提供全方位的臨床研究服務(wù)，涵蓋生物等效性（BE）/1期至4期的臨床試驗(yàn)及真實(shí)世界研究，助力新藥通過(guò)核查上市。

相信未來(lái)，我們會(huì)見(jiàn)證更多好藥新藥的誕生。在新藥研發(fā)的征途上，藥明康德也將一如既往陪伴合作伙伴們前行，見(jiàn)證更多突破性療法的誕生，為更多患者點(diǎn)亮生的希望。

Targeting Lung Cancer, Empowering Lives: WuXi AppTec’s Commitment to Innovation

Lung cancer remains one of the deadliest malignancies worldwide, particularly in its advanced stages. However, the emergence of targeted therapies for non-small cell lung cancer (NSCLC) has reshaped the treatment landscape, offering renewed hope to patients with specific mutations. Behind these breakthroughs is the tireless work of scientists, clinicians, and global partners. WuXi AppTec, through its fully integrated CRDMO (Contract Research, Development, and Manufacturing Organization) model, is playing a critical role in accelerating the development of next-generation targeted therapies. By supporting partners from early discovery through to clinical development and regulatory submission, WuXi AppTec is helping to bring life-changing treatments to patients worldwide—faster and more efficiently.

Unmet Needs in Advanced NSCLC

Lung cancer continues to rank among the most prevalent and fatal cancers globally, with an alarming five-year survival rate of just 20% for advanced-stage patients. Non-small cell lung cancer (NSCLC) represents approximately 85% of all lung cancer cases and poses unique treatment challenges due to its typically late-stage diagnosis. Alarmingly, over 70% of NSCLC patients are diagnosed at an advanced stage, where conventional therapies like chemotherapy and radiotherapy often fall short in efficacy and tolerability.

A particularly daunting complication in advanced NSCLC is brain metastasis, which is notoriously difficult to treat. Traditional therapeutic approaches often fail to cross the blood-brain barrier or effectively target intracranial lesions, leading to limited treatment options and poor prognosis. This underscores the urgent need for therapies with better CNS penetration and greater target specificity.

Yet, recent advances in molecular biology have illuminated new therapeutic paths. Over the past two decades, researchers have identified a broad range of actionable mutations in multiple genes—including

EGFR

ALK

KRAS

MET

RET

, and

BRAF

—that drive disease progression in NSCLC. Many of these mutations are now being addressed with targeted therapies capable of significantly improving survival and quality of life—even in patients with brain metastases. In fact, dozens of therapies have already received FDA approval, with more than 900 candidates currently in clinical development, reflecting the strength and momentum of this scientific movement.

From Biomarkers to Breakthroughs

The rise of precision oncology has sparked a new generation of targeted therapies that have redefined the NSCLC treatment paradigm. WuXi AppTec has been instrumental in propelling this wave of innovation forward by offering a robust, end-to-end CRDMO model that seamlessly connects research, development, and manufacturing within one integrated platform.

At the early discovery stage, WuXi AppTec supports partners with comprehensive services, including small molecule discovery, formulation optimization, CMC development, pharmacology and pharmacokinetics, toxicology studies, IND-enabling research, and regulatory submissions. These capabilities not only reduce time to clinic but also enhance translational quality and clinical readiness of candidate therapies.

WuXi AppTec provides integrated, regulatory-compliant solutions that support every stage of clinical development—from Phase I to Phase IV. In one case, involving a KRAS inhibitor, WuXi AppTec combined advanced computational modeling with empirical data to predict clinical pharmacokinetics and optimize dosing strategies—maximizing both efficacy and patient safety.

Catalyzing Innovation, Expanding Hope

Thanks to industry-wide collaboration and continued scientific advances, the landscape of targeted NSCLC therapies is evolving at a rapid pace. With hundreds of therapies under clinical evaluation and a growing number of approvals, the field is steadily advancing toward more personalized and effective treatment options.

WuXi AppTec’s integrated CRDMO model has played a vital role in catalyzing this progress. By enabling seamless transitions from discovery to development and commercialization, the company empowers global innovators to reduce risk, accelerate timelines, and improve probability of regulatory success. Its infrastructure supports not only IND, NDA, and BLA filings but also real-world evidence (RWE) studies—offering a full-spectrum approach to therapeutic advancement.

Importantly, WuXi AppTec’s services help biopharma partners overcome many of the core challenges in targeted therapy development, from complex biomarker validation to precise PK/PD modeling and scalable manufacturing. As more therapies emerge for defined subgroups, speed and precision will remain paramount—and WuXi AppTec is uniquely positioned to deliver both.

With a mission to enable "every drug can be made and every disease can be treated," WuXi AppTec continues to evolve with its partners, lighting the way for new therapeutic frontiers. By accelerating the delivery of novel, targeted therapies, WuXi AppTec is not only advancing science—it is helping bring renewed hope and life-changing possibilities to patients and families facing the challenge of lung cancer.

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