編者按：2025年，癌癥治療領(lǐng)域持續(xù)迎來多項(xiàng)積極進(jìn)展。新批準(zhǔn)的藥物不僅顯著提高了患者的生存率，而且為整個(gè)生物醫(yī)藥界帶來進(jìn)一步的創(chuàng)新。其中，多款新型小分子療法獲得美國FDA批準(zhǔn)，而靶向蛋白降解劑、抗體偶聯(lián)藥物（ADC）與雙特異性抗體仍是產(chǎn)業(yè)持續(xù)關(guān)注的焦點(diǎn)。作為創(chuàng)新的賦能者、客戶信賴的合作伙伴以及全球健康產(chǎn)業(yè)的貢獻(xiàn)者，藥明康德將持續(xù)通過獨(dú)特的“CRDMO”業(yè)務(wù)模式，助力更多合作伙伴，為全球病患帶來突破性創(chuàng)新療法。本文將根據(jù)近期《自然》子刊

Nature Cancer

所發(fā)布的觀點(diǎn)文章并結(jié)合公開訊息，回顧在2025年癌癥治療領(lǐng)域的藥物研發(fā)與產(chǎn)業(yè)進(jìn)展。

小分子領(lǐng)域持續(xù)向前

在靶向蛋白降解劑領(lǐng)域，Jazz Pharmaceuticals開發(fā)的“first-in-class”藥物Modeyso（dordaviprone）于8月獲FDA加速批準(zhǔn)上市，用于治療1歲及以上、攜帶H3 K27M突變且在既往治療后疾病進(jìn)展的彌漫性中線膠質(zhì)瘤成人和兒童患者。

同月，美國FDA受理了Arvinas與輝瑞（Pfizer）遞交的vepdegestrant新藥申請(qǐng)，擬用于治療既往接受內(nèi)分泌治療的、雌激素受體陽性（ER+）、HER2陰性（HER2-）且伴有

ESR1

突變的晚期或轉(zhuǎn)移性乳腺癌患者。新聞稿指出，vepdegestrant是首個(gè)在乳腺癌患者中顯示臨床獲益的PROTAC?療法，若獲批，將成為首個(gè)美國FDA批準(zhǔn)的PROTAC?雌激素受體降解劑。

9月，禮來（Eli Lilly and Company）口服選擇性雌激素受體降解劑（SERD）Inluriyo（imlunestrant）獲批用于治療ER+/HER2-且伴有

ESR1

突變的晚期或轉(zhuǎn)移性乳腺癌患者。羅氏（Roche）也于12月宣布，其口服新一代SERD療法giredestrant在ER+/HER2-早期乳腺癌患者的3期試驗(yàn)達(dá)到主要終點(diǎn)，顯著降低侵襲性疾病復(fù)發(fā)或死亡風(fēng)險(xiǎn)達(dá)30%。

FDA今年還批準(zhǔn)了多款口服酪氨酸激酶抑制劑（TKI），包括拜耳（Bayer）的Hyrnuo（sevabertinib）、勃林格殷格翰（Boehringer Ingelheim）的Hernexeos（zongertinib）、迪哲醫(yī)藥的Zegfrovy（sunvozertinib）、Nuvation Bio的Ibtrozi（taletrectinib），均用于治療非小細(xì)胞肺癌（NSCLC）患者。此外，Kura Oncology與Kyowa Kirin聯(lián)合開發(fā)的口服menin抑制劑Komzifti（ziftomenib），以及Deciphera Pharmaceuticals與Ono Pharmaceutical聯(lián)合開發(fā)的CSF1R抑制劑Romvimza（vimseltinib），也分別獲批用于治療攜帶

NPM1

突變的復(fù)發(fā)/難治性急性髓系白血病（AML）和腱鞘巨細(xì)胞瘤（TGCT）患者。

與此同時(shí)，美國FDA于5月加速批準(zhǔn)Verastem Oncology開發(fā)的RAF/MEK抑制劑avutometinib聯(lián)合FAK抑制劑defactinib組成的治療方案Avmapki Fakzynja Co-pack，用于治療復(fù)發(fā)性低級(jí)別漿液性卵巢癌（LGSOC）成年患者，這些患者曾接受系統(tǒng)性治療且腫瘤攜帶

KRAS

突變。這一組合屬于少見的“兩個(gè)新藥”同時(shí)獲批的案例，而不僅僅是包含已上市藥物的組合方案。

此外，F(xiàn)DA還批準(zhǔn)了Medexus Pharmaceuticals旗下Grafapex（treosulfan）作為烷化劑，與氟達(dá)拉濱（fludarabine）聯(lián)合使用，作為1歲及以上AML或骨髓增生異常綜合征（MDS）患者接受同種異體造血干細(xì)胞移植（alloHSCT）前的預(yù)處理方案。

抗體偶聯(lián)藥物繼續(xù)發(fā)力

2025年，F(xiàn)DA共批準(zhǔn)兩款新的抗體偶聯(lián)藥物。其中，由阿斯利康（AstraZeneca）與第一三共（Daiichi Sankyo）聯(lián)合開發(fā)的Trop2靶向ADC療法Datroway（datopotamab deruxtecan）于1月獲批，用于治療經(jīng)治激素受體陽性（HR+）、HER2-乳腺癌患者，并在6月再獲加速批準(zhǔn)，用于治療攜帶

EGFR

突變的NSCLC患者。與此同時(shí)，艾伯維（AbbVie）旗下c-Met靶向ADC療法Emrelis（telisotuzumab vedotin，teliso-V）也于今年5月獲得FDA加速批準(zhǔn)，用于治療具有高c-Met蛋白過度表達(dá)的局部晚期或轉(zhuǎn)移性經(jīng)治非鱗狀NSCLC成年患者。

值得一提的是，GSK旗下B細(xì)胞成熟抗原（BCMA）靶向ADC于10月重新獲批，可與硼替佐米和地塞米松（BVd）聯(lián)合使用，用于治療至少接受過兩種既往療法的復(fù)發(fā)或難治性多發(fā)性骨髓瘤（RRMM）成年患者。此外，Genmab在去年4月通過收購普方生物（ProfoundBio）獲得的潛在“best-in-class”葉酸受體α（FRα）靶向ADC療法rinatabart sesutecan（Rina-S），也在今年8月獲FDA授予突破性療法認(rèn)定（BTD），用于治療在含鉑化療方案及PD-1/PD-（L）1治療后仍復(fù)發(fā)或進(jìn)展的子宮內(nèi)膜癌（EC）成年患者。目前，該療法用于EC的3期研究正在推進(jìn)中。

除已上市產(chǎn)品外，多家致力于新一代ADC技術(shù)平臺(tái)的創(chuàng)新企業(yè)也獲得了大額融資，推動(dòng)賽道持續(xù)升溫。這些新平臺(tái)多聚焦于提升藥物穩(wěn)定性、精準(zhǔn)靶向能力，或開發(fā)創(chuàng)新藥物載荷。例如，Callio Therapeutics致力于開發(fā)可同時(shí)攜帶兩種不同載荷的雙載荷ADC，以進(jìn)一步增強(qiáng)治療效力，公司于3月成立并獲得1.87億美元融資。而專注于創(chuàng)新載荷開發(fā)的Adcytherix則在10月融資1.05億歐元。同月，Tubulis完成C輪融資第二次增資，使該輪融資總額達(dá)到3.44億歐元。

Tubulis的主打候選藥物TUB-040是一款靶向NaPi2b抗原的IgG1抗體，通過其專有P5偶聯(lián)技術(shù)與拓?fù)洚悩?gòu)酶I抑制劑exatecan連接，形成帶有可切割連接子的ADC療法，旨在治療NaPi2b高表達(dá)的卵巢癌和肺腺癌。臨床1/2a期研究中期數(shù)據(jù)顯示，所有劑量組的總體確認(rèn)疾病控制率（DCR）達(dá)91%。

雙特異性抗體與抗體療法進(jìn)展

今年，PD-1/VEGF雙特異性抗體領(lǐng)域進(jìn)展顯著。其中，Akeso與Summit Therapeutics聯(lián)合開發(fā)的ivonescimab受到廣泛關(guān)注。在一項(xiàng)全球3期研究中，相較單純化療，ivonescimab聯(lián)合化療在攜帶

EGFR

突變的NSCLC患者中顯示出改善總生存期（OS）的趨勢(shì)。此外，其聯(lián)合化療用于治療無法切除或轉(zhuǎn)移性結(jié)直腸癌（CRC）患者的全球3期試驗(yàn)也已于10月啟動(dòng)。

在產(chǎn)業(yè)合作方面，輝瑞（Pfizer）與三生制藥（3SBio）于5月簽署全球獨(dú)家許可協(xié)議，總金額高達(dá)12.5億美元，用于開發(fā)、生產(chǎn)和商業(yè)化PD-1/VEGF雙特異性抗體SSGJ-707。6月，BioNTech與百時(shí)美施貴寶（Bristol Myers Squibb）達(dá)成15億美元合作，共同開發(fā)PD-L1/VEGF-A靶向雙特異性抗體pumitamig。在12月公布的全球2期試驗(yàn)中，在39例可評(píng)估患者中，pumitamig聯(lián)合化療治療局部晚期或轉(zhuǎn)移性三陰性乳腺癌（TNBC）患者的確認(rèn)客觀緩解率（ORR）達(dá)到61.5%，未確認(rèn)ORR為71.8%，DCR為92.3%。目前，已有超過十個(gè)VEGF與PD-1/PD-L1聯(lián)合靶向療法進(jìn)入臨床階段。

除該領(lǐng)域外，其他雙特異性抗體也取得重要進(jìn)展。7月，美國FDA加速批準(zhǔn)再生元（Regeneron Pharmaceuticals）旗下Lynozyfic（linvoseltamab）用于治療RRMM成人患者。9月底，Genmab宣布以80億美元收購Merus，其核心資產(chǎn)為處于后期開發(fā)階段的EGFR/LGR5靶向雙特異性抗體petosemtamab，已進(jìn)入兩項(xiàng)頭頸癌3期臨床試驗(yàn)，覆蓋一線及二/三線治療場(chǎng)景，預(yù)計(jì)其中一至兩項(xiàng)試驗(yàn)將在2026年獲得中期結(jié)果。由于LGR5在多種癌癥中表達(dá)上調(diào)，已成為ADC與T細(xì)胞銜接器的重要靶點(diǎn)。

同時(shí)，武田（Takeda）與信達(dá)生物（Innovent Biologics）于10月達(dá)成合作，協(xié)議中也包括一款靶向PD-1及免疫調(diào)節(jié)蛋白亞基IL-2α的雙特異性融合蛋白。另一方面，阿斯利康（AstraZeneca）旗下PD-1/TIGIT靶向雙特異性抗體rilvegostomig用于治療NSCLC的3期試驗(yàn)正在推進(jìn)中。Rilvegostomig與ADC療法Datroway聯(lián)合用于治療晚期或轉(zhuǎn)移性尿路上皮癌患者的2期試驗(yàn)顯示積極結(jié)果，在不適合順鉑的一線患者中，ORR達(dá)到68.2%，DCR達(dá)95.5%，相關(guān)2/3期研究已啟動(dòng)。

除雙特異性抗體外，其他抗體療法也迎來新進(jìn)展。美國FDA與歐洲藥品管理局（EMA）分別于9月與11月批準(zhǔn)了默沙東（MSD）旗下Keytruda（pembrolizumab）的皮下注射制劑。由康方生物與正大天晴聯(lián)合開發(fā)的抗PD-1單抗Anniko（penpulimab）也在4月獲批用于治療鼻咽癌。同時(shí)，吉利德科學(xué)（Gilead Sciences）與Arcus Biosciences聯(lián)合評(píng)估Fc失活型抗TIGIT抗體domvanalimab聯(lián)合抗PD-1單抗zimberelimab及化療用于胃癌等患者一線治療的2期研究也傳來積極結(jié)果，接受該聯(lián)合療法患者的中位總生存期達(dá)26.7個(gè)月。

細(xì)胞治療走向體內(nèi)生成CAR-T細(xì)胞模式

在細(xì)胞治療領(lǐng)域，行業(yè)關(guān)注逐步轉(zhuǎn)向體內(nèi)生成CAR-T細(xì)胞療法。這一模式不僅生產(chǎn)流程更為簡化、成本更低，同時(shí)有望實(shí)現(xiàn)更精準(zhǔn)、更高效的細(xì)胞改造。吉利德科學(xué)旗下Kite公司于8月達(dá)成協(xié)議，以高達(dá)3.5億美元收購Interius BioTherapeutics。該公司平臺(tái)可在患者體內(nèi)直接生成CAR-T細(xì)胞，僅需一次靜脈輸注即可完成治療，無需預(yù)處理化療或復(fù)雜細(xì)胞操作，其主打療法INT2104目前已進(jìn)入1期試驗(yàn)階段。

與此同時(shí)，由諾貝爾獎(jiǎng)得主Jennifer Doudna博士共同創(chuàng)立的Azalea Therapeutics于11月正式走出隱匿模式，并完成總計(jì)8200萬美元的種子輪及A輪融資，用于推進(jìn)其自主研發(fā)的包膜遞送載體（EDV）技術(shù)平臺(tái)。該平臺(tái)已成功在體內(nèi)將編碼CAR的轉(zhuǎn)基因?qū)隩細(xì)胞，實(shí)現(xiàn)無需細(xì)胞體外擴(kuò)增與預(yù)處理的持續(xù)抗腫瘤治療效果。

放射性配體療法穩(wěn)步推進(jìn)

2025年放射性配體療法（RLT）的臨床推進(jìn)與投融資活動(dòng)依然活躍。諾華（Novartis）旗下β粒子治療藥物Pluvicto（lutetium Lu 177 vipivotide tetraxetan）再獲FDA批準(zhǔn)，用于治療PSMA陽性轉(zhuǎn)移性去勢(shì)抵抗性前列腺癌患者。在α粒子藥物領(lǐng)域，賽諾菲（Sanofi）于10月宣布，其在研RLT藥物AlphaMedix（212Pb-DOTAMTATE）治療不可切除或轉(zhuǎn)移性、生長抑素受體（SSTR）陽性胃腸胰神經(jīng)內(nèi)分泌腫瘤（GEP-NET）患者的2期試驗(yàn)達(dá)到全部主要療效終點(diǎn)，并顯著提升總緩解率。

縱觀全年，可以看到無論是小分子、ADC、雙特異性抗體，還是細(xì)胞治療與放射性配體療法，創(chuàng)新的浪潮正在更快地從實(shí)驗(yàn)室走向臨床。隨著不同療法模式的興起，以及產(chǎn)業(yè)與學(xué)術(shù)界的通力合作，相信在即將到來的2026年會(huì)有更多好消息傳出，推動(dòng)癌癥治療的進(jìn)步，造福更多癌癥患者。

展望未來，藥明康德將繼續(xù)秉持“讓天下沒有難做的藥，難治的病”的愿景，依托全球研發(fā)基地與生產(chǎn)網(wǎng)絡(luò)，以獨(dú)特的一體化、端到端的CRDMO模式，提供高效、靈活的解決方案，持續(xù)賦能全球合作伙伴釋放創(chuàng)新潛能，加速將科學(xué)突破轉(zhuǎn)化成為新藥、好藥。

Major Milestones in Cancer Treatment Revealed for 2025

In 2025, the field of cancer therapy continued to deliver encouraging advances. Newly approved therapies have not only significantly improved patient survival, but have also driven further innovation across the global biopharmaceutical industry. A major spotlight in 2025 fell on next-generation small-molecule medicines, several of which received U.S. FDA approval, while targeted protein degraders, antibody–drug conjugates (ADCs) and bispecific antibodies remained at the center of attention. As an enabler of innovation, a trusted partner, and a contributor to the global pharmaceutical and life sciences industry, WuXi AppTec will continue to support its partners through its unique CRDMO business model, helping deliver breakthrough treatments to patients worldwide. Drawing upon the latest feature article published in

Nature Cancer

alongside publicly available information, this article reviews key R&D and industry developments in cancer therapy in 2025.

Continued Progress in Small-Molecule Innovation

In targeted protein degradation, Jazz Pharmaceuticals’ first-in-class therapy Modeyso (dordaviprone) received accelerated approval from FDA in August for adults and children aged one year and older with H3 K27M-mutant diffuse midline glioma whose disease progressed following prior therapy.

That same month, the FDA accepted the New Drug Application submitted by Arvinas and Pfizer for vepdegestrant to treat estrogen receptor-positive (ER+)/HER2-negative (HER2-) advanced or metastatic breast cancer with

ESR1

mutation following prior endocrine therapy. According to company statements, vepdegestrant is the first PROTAC? therapy to demonstrate clinical benefit in breast cancer patients and, if approved, would become the first FDA-approved PROTAC? estrogen receptor degrader.

In September, Eli Lilly’s oral selective estrogen receptor degrader (SERD) Inluriyo (imlunestrant) was approved for ER+/HER2- advanced or metastatic breast cancer with

ESR1

mutation. Roche also announced in December thatits next-generation oral SERD giredestrant met the primary endpoint in a Phase 3 trial in ER+/HER2- early-stage breast cancer, reducing the risk of invasive disease recurrence or death by 30%.

This year, the FDA also approved several oral tyrosine kinase inhibitors (TKIs) fornon-small cell lung cancer (NSCLC), including Hyrnuo (sevabertinib) from Bayer, Hernexeos (zongertinib) from Boehringer Ingelheim, Zegfrovy (sunvozertinib) from Dizal [Jiangsu] Pharmaceutical, and Ibtrozi (taletrectinib) from Nuvation Bio. In addition, the oral menin inhibitor Komzifti (ziftomenib), co-developed by Kura Oncology and Kyowa Kirin, was approved for relapsed or refractory acute myeloid leukemia (AML) with

NPM1

mutation, while the CSF1R inhibitor Romvimza (vimseltinib), co-developed by Deciphera Pharmaceuticals and Ono Pharmaceutical, was approved for tenosynovial giant cell tumor (TGCT).

Also in May, the FDA granted accelerated approval to the combination regimen Avmapki Fakzynja Co-pack, which consists of the RAF/MEK inhibitor avutometinib and FAK inhibitor defactinib from Verastem Oncology, for adults with recurrent low-grade serous ovarian cancer (LGSOC) harboring

KRAS

mutation who previously received systemic therapy. This represents a rare case where two new molecular entities were approved together as a combination treatment.

In addition, the FDA approved Grafapex (treosulfan) from Medexus Pharmaceuticals as an alkylating agent to be used with fludarabine as a conditioning regimen prior to allogeneic hematopoietic stem cell transplantation (alloHSCT) in adults and children aged one year and older with AML or myelodysplastic syndromes (MDS).

Antibody–Drug Conjugates Continue to Advance

In 2025, the FDA approved two new ADCs.Datroway (datopotamab deruxtecan), a Trop2-targeting ADC co-developed by AstraZeneca and Daiichi Sankyo, was approved in January for the treatment of previously treated hormone receptor-positive (HR+)/HER2- breast cancer, and subsequently received accelerated approval in June for patients with

EGFR

-mutated NSCLC. Meanwhile, AbbVie’s c-Met-targeting ADC Emrelis (telisotuzumab vedotin, teliso-V) received accelerated FDA approval in May for adults with locally advanced or metastatic, previously treated non-squamous NSCLC whose tumors overexpress c-Met.

Notably, GSK’s B-cell maturation antigen (BCMA)-targeting ADC was re-approved in October for use in combination with bortezomib and dexamethasone (BVd) to treat adults with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least two prior lines of therapy. In addition, the potential “best-in-class” folate receptor-α (FRα)-targeting ADC rinatabart sesutecan (Rina-S) — acquired by Genmab via its April 2024 purchase of ProfoundBio — was granted FDA Breakthrough Therapy Designation (BTD) in August 2025 for adults with endometrial cancer (EC) whose disease recurred or progressed following platinum-based chemotherapy and PD-(L)1 therapy. A Phase 3 trial in EC is currently underway.

Investment momentum also strengthened across next-generation ADC technology platforms aimed at improving stability, precision targeting, and payload innovation.Callio Therapeutics, which is developing dual-payload ADCs designed to further enhance anti-tumor activity, was founded in March and raised US$187 million. Adcytherix, focused on novel payload innovation, secured €105 million in October. That same month, Tubulis completed a second extension of its Series C round, bringing total proceeds to €344 million.

Tubulis’ lead candidate, TUB-040, is an IgG1 antibody targeting the NaPi2b antigen and conjugated via the company’s proprietary P5 platform to the topoisomerase-I inhibitor exatecan through a cleavable linker. It is being developed for NaPi2b-high ovarian and lung adenocarcinoma. Interim Phase 1/2a data showed a confirmed disease control rate (DCR) of 91% across all dose cohorts.

Progress in Bispecific Antibodies and Antibody-Based Therapies

Significant momentum was also seen in the field of PD-1/VEGF bispecific antibodies.Ivonescimab, jointly developed by Akeso and Summit Therapeutics, drew substantial industry attention in 2025. In a global Phase 3 trial, ivonescimab plus chemotherapy demonstrated a trend toward improved overall survival (OS) versus chemotherapy alone in

EGFR

-mutated NSCLC. A global Phase 3 trial of ivonescimab plus chemotherapy in unresectable or metastatic colorectal cancer (CRC) was also initiated in October.

On the partnership front, Pfizer and 3SBio signed a global exclusive licensing agreement in May worth up to US$1.25 billion to develop, manufacture, and commercialize the PD-1/VEGF bispecific antibody SSGJ-707. In June, BioNTech and Bristol Myers Squibb entered into a US$1.5 billion collaboration to co-develop the PD-L1/VEGF-A bispecific antibody pumitamig. In a global Phase 2 study reported in December, among 39 evaluable patients with locally advanced or metastatic triple-negative breast cancer (TNBC), pumitamig plus chemotherapy achieved a confirmed objective response rate (ORR) of 61.5%, an unconfirmed ORR of 71.8%, and a DCR of 92.3%.Today, more than ten VEGF + PD-1/PD-L1-targeting bispecific programs are in clinical development.

Progress extended beyond this class as well. In July, the U.S. FDA granted accelerated approval to Regeneron Pharmaceuticals’ bispecific antibody Lynozyfic (linvoseltamab) for adults with R/R multiple myeloma (MM). In late September, Genmab announced the US$8 billion acquisition of Merus, whose lead late-stage bispecific antibody petosemtamab targets EGFR and LGR5. The therapy is currently being evaluated in two Phase 3 head-and-neck cancer trials across first-line and later-line settings, with interim data expected in 2026.Given its upregulated expression across several tumor types, LGR5 has emerged as an increasingly important target for ADCs and T-cell engagers.

In addition, Takeda and Innovent Biologics entered into a collaboration in October that includes a PD-1/IL-2α bispecific fusion protein candidate. AstraZeneca’s PD-1/TIGIT bispecific antibody rilvegostomig is also advancing in a Phase 3 trial for NSCLC. In a Phase 2 study evaluating rilvegostomig in combination with the ADC Datroway in advanced or metastatic urothelial carcinoma, the regimen achieved an ORR of 68.2% and a DCR of 95.5% in cisplatin-ineligible first-line patients. Related Phase 2/3 trials are now underway.

Beyond bispecifics, other antibody-based therapies also saw progress. The U.S. FDA and European Medicines Agency (EMA) approved the subcutaneous formulation of Keytruda (pembrolizumab) in September and November, respectively. The anti-PD-1 antibody Anniko (penpulimab), co-developed by Akeso and Chia Tai Tianqing Pharmaceutical, was approved in April for nasopharyngeal carcinoma. Meanwhile, Gilead Sciences and Arcus Biosciences reported positive Phase 2 data showing that domvanalimab — an Fc-silent anti-TIGIT antibody — plus the anti-PD-1 antibody zimberelimab and chemotherapy achieved a median OS of 26.7 months as first-line therapy in gastric and related cancers.

Cell Therapy Advances Toward In-Vivo CAR-T Generation

In the cell therapy field, industry attention is increasingly shifting toward in-vivo CAR-T cell generation, an approach that simplifies manufacturing, reduces cost, and may enable more precise and durable cell reprogramming. In August, Kite, a Gilead Sciences company, entered into an agreement to acquire Interius BioTherapeutics for up to US$350 million. Interius’ platform enables direct in-vivo generation of CAR-T cells via a single intravenous infusion, eliminating the need for chemotherapy preconditioning or ex-vivo cell handling. Its lead asset, INT2104, is currently in Phase 1 testing.

Meanwhile, Azalea Therapeutics — co-founded by Nobel laureate Dr. Jennifer Doudna — emerged from stealth in November and announced a combined US$82 million seed and Series A financing to advance its proprietary Enveloped Delivery Vehicle (EDV) platform. The technology has demonstrated successful delivery of CAR-encoding transgenes into T cells in-vivo, achieving durable anti-tumor responses without the need for cell expansion or preconditioning.

Radiopharmaceutical Therapies Progress Steadily

Clinical development and investment activity in radioligand therapy (RLT) continued at a steady pace in 2025.Novartis’ β-emitting therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) received an additional FDA approval for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). In the α-emitter space, Sanofi announced in October that its RLT candidate AlphaMedix (212Pb-DOTAMTATE) met all primary efficacy endpoints in a Phase 2 study in patients with unresectable or metastatic somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs), delivering a meaningful improvement in overall response rate.

Looking across the year, innovation is clearly moving from bench to bedside at a steady pace, spanning small molecules, ADCs, bispecific antibodies, cell therapies, and radiopharmaceuticals. As new therapeutic modalities emerge and industry–academia collaboration deepens, we look ahead to 2026 with optimism that more breakthroughs will follow, bringing hope and better treatment options to patients worldwide.

At WuXi AppTec, we remain committed to advancing transformative therapies for global patients. Together with our partners, we work toward a shared vision that “every drug can be made and every disease can be treated.”

參考資料：

[1] Senior M. Cancer drug approvals and setbacks in 2025. Nat Cancer. 2025 Dec;6(12):1902-1904. doi: 10.1038/s43018-025-01080-4. PMID: 41372474.

[2] Genmab Announces New Data Demonstrating Investigational Rinatabart Sesutecan (Rina-S?) Achieved Anti-Tumor Activity in Heavily Pretreated Patients with Advanced Endometrial Cancer. Retrieved December 28, 2025 from https://www.globenewswire.com/news-release/2025/10/18/3168951/0/en/Genmab-Announces-New-Data-Demonstrating-Investigational-Rinatabart-Sesutecan-Rina-S-Achieved-Anti-Tumor-Activity-in-Heavily-Pretreated-Patients-with-Advanced-Endometrial-Cancer.html

[3] Longer-Term Follow-Up of Western Patients Showed Improving, Favorable Trend in Overall Survival in Global Phase III HARMONi Clinical Trial for Ivonescimab Plus Chemotherapy in 2L+ EGFRm NSCLC. Retrieved December 28, 2025 from https://www.businesswire.com/news/home/20250907860109/en/Longer-Term-Follow-Up-of-Western-Patients-Showed-Improving-Favorable-Trend-in-Overall-Survival-in-Global-Phase-III-HARMONi-Clinical-Trial-for-Ivonescimab-Plus-Chemotherapy-in-2L-EGFRm-NSCLC

[4] Summit Therapeutics Announces Expansion of Ivonescimab Global Phase III Development Program with HARMONi-GI3 Study in 1L Colorectal Cancer. Retrieved December 28, 2025 from https://www.businesswire.com/news/home/20251017270897/en/Summit-Therapeutics-Announces-Expansion-of-Ivonescimab-Global-Phase-III-Development-Program-with-HARMONi-GI3-Study-in-1L-Colorectal-Cancer

[5] BioNTech and Bristol Myers Squibb Present First Global Phase 2 Data for PD-L1xVEGF-A Bispecific Antibody Pumitamig Showing Encouraging Efficacy in Advanced Triple-Negative Breast Cancer. Retrieved December 9, 2025 from https://news.bms.com/news/details/2025/BioNTech-and-Bristol-Myers-Squibb-Present-First-Global-Phase-2-Data-for-PD-L1xVEGF-A-Bispecific-Antibody-Pumitamig-Showing-Encouraging-Efficacy-in-Advanced-Triple-Negative-Breast-Cancer/default.aspx

[6] Innovent Biologics Announces Global Strategic Partnership with Takeda to Bring Innovent's Next Gen IO Backbone Therapy and ADC Molecules to the Global Market. Retrieved December 28, 2025 from https://www.prnewswire.com/news-releases/innovent-biologics-announces-global-strategic-partnership-with-takeda-to-bring-innovents-next-gen-io-backbone-therapy-and-adc-molecules-to-the-global-market-302590770.html

[7] Azalea Therapeutics Presents New Preclinical Data Demonstrating Robust In Vivo Generation of TRAC-CAR T Cells Using Enveloped Delivery Vehicles (EDVs). Retrieved December 28, 2025 from https://www.globenewswire.com/news-release/2025/11/20/3192000/0/en/Azalea-Therapeutics-Presents-New-Preclinical-Data-Demonstrating-Robust-In-Vivo-Generation-of-TRAC-CAR-T-Cells-Using-Enveloped-Delivery-Vehicles-EDVs.html

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。

版權(quán)說明：歡迎個(gè)人轉(zhuǎn)發(fā)至朋友圈，謝絕媒體或機(jī)構(gòu)未經(jīng)授權(quán)以任何形式轉(zhuǎn)載至其他平臺(tái)。轉(zhuǎn)載授權(quán)請(qǐng)?jiān)凇杆幟骺档隆刮⑿殴娞?hào)回復(fù)“轉(zhuǎn)載”，獲取轉(zhuǎn)載須知。