[{"_1":2,"_3":-5,"_4":-5},"loaderData",{"_5":6,"_7":8},"actionData","errors","root",{"_102":103},"en-item",{"_9":10,"_10":11},"kind","item",{"_12":13,"_14":15,"_16":17,"_18":19,"_20":21,"_22":23,"_24":25,"_26":27,"_28":29,"_30":31,"_32":31,"_33":34,"_35":36,"_37":38,"_39":40,"_41":42,"_43":44,"_45":46,"_47":-5,"_48":49,"_50":-5,"_51":-5,"_52":53,"_54":55,"_56":57,"_58":42,"_59":42,"_60":61,"_62":42,"_63":64},"id","u4ppmssft0ri2k7pfrj1y9zwi","revision",2,"title","Crescent Biopharma 更新临床试验进展","originalTitle","CRESCENT BIOPHARMA, INC. (0001253689) (Filer)","summary","Crescent Biopharma, Inc. 在10月15日发布的8-K文件中披露了其临床试验进展，包括CR-001在多个肿瘤类型中的试验计划，以及CR-002的全球Phase 1/2 APOLLO试验预计在2026年第四季度启动。此外，公司还计划与Kelun-Biotech合作开展多项ADC组合研究。","reason","Crescent Biopharma 更新了其临床试验进展，包括CR-001和CR-002的多项试验计划，涉及多个肿瘤类型和化疗组合。","source",{"_12":93,"_94":95,"_9":96,"_97":42,"_98":99,"_100":101},"links",{"_90":91,"_78":92},"publishedAt","2026-10-15T20:26:10.000Z","discoveredAt","2026-10-15T22:19:19.541Z","timelineAt","category","ai-products","tags",[84,85,86,87,88,89],"stockSymbols",[83],"score",65,"selected",true,"channel","news","story",{"_73":74,"_16":75},"x","readingMode","full","author","language","body",{"_64":77,"_78":-5,"_79":80,"_81":82},"outline",[],"relatedStories",[76],"indexable","markdownAvailable","group",{"_65":66,"_45":67,"_68":69,"_70":71,"_72":71},"hasTranslation","bodyLanguage","zh","factId","fq9hlyXP837M",{"_73":74,"_16":75},"reportCount",1,"additionalSourceCount",0,"developmentCount","publicId","6ff99003-e25a-4ea2-9d03-038535680a37","Crescent Biopharma 临床试验进展披露",{"_73":74,"_16":75},"

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

________________________________________________________________________________________________

FORM 8-K

________________________________________________________________________________________________

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): October 15, 2026

________________________________________________________________________________________________

Crescent Biopharma, Inc.

(Exact Name of Registrant as Specified in Charter)

________________________________________________________________________________________________


Cayman Islands	001-36177	06-1686563
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

300 Fifth Avenue Waltham, MA		02451
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: (617) 430-5595

Not applicable

(Former Name or Former Address, if Changed Since Last Report)

________________________________________________________________________________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):


o	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading symbol(s)

Name of each exchange on which registered

Ordinary Shares, $0.001 par value per share

CBIO

The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company o

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Item 8.01 Other Events.

On October 15, 2026, Crescent Biopharma, Inc. (“Crescent” or the “Company”) issued a press release announcing clinical pipeline updates, including (i) enrolling patients in cohorts combining CR-001, a PD-1 x VEGF bispecific antibody, plus standard of care chemotherapy regimens in its global Phase 1/2 ASCEND trial, (ii) the initiation of additional antibody-drug conjugates (“ADCs”) combination studies with CR-001, (iii) anticipated initiation of the Phase 1/2 APOLLO trial of CR-002, a topoisomerase inhibitor ADC targeting PD-L1, and (iv) the expected timing of clinical data readouts.

Clinical Execution Progress in ASCEND, a Global Phase 1/2 Trial of CR-001

在CR-001作为单药的全球1/2期ASCEND试验中，公司已完成剂量爬坡，并在美国、欧洲和韩国的临床试验机构中纳入了多种肿瘤类型的受试者。公司预计将在2027年第一季度报告ASCEND的初步单药数据，包括来自最多12名一线非小细胞肺癌（\"NSCLC\"）队列的总体缓解率（\"ORR\"）的初步抗肿瘤反应，以及来自超过125名未接受过治疗和接受过治疗的多种实体瘤患者的安全部分、耐受性、药代动力学和药效动力学数据。

ASCEND的标准护理化疗联合扩展队列也已开始招募受试者。公司计划评估多种肿瘤类型和化疗方案，包括以下类型，初步数据预计将于2027年年中公布：

•一线（1L）非小细胞肺癌（NSCLC）：CR-001 + 紫杉醇和卡铂（鳞状）或培美曲塞和卡铂（非鳞状）

•一线错配修复功能正常（\"pMMR\"）/微卫星稳定（\"MSS\"）结直肠癌（\"CRC\"）：CR-001 + mFOLFOX6

•三线（3L）结直肠癌：CR-001 + 三氟尿苷和替吡嘧啶

•一线胆道癌：CR-001 + 吉西他滨和顺铂

•一线错配修复功能正常（\"pMMR\"）子宫内膜癌：CR-001 + 卡铂和紫杉醇

•一线程序性死亡配体（\"PD-L1\"）表达的胃/胃食管交界（\"GEJ\"）癌：CR-001 + 卡培他滨和奥沙利铂

•二线PD-L1表达的胃/GEJ癌：CR-001 + 紫杉醇

在结果公布及与监管机构进一步沟通后，公司计划于2028年初启动CR-001的多项3期试验。

Kelun-Biotech联合研究

与公司合作的Kelun-Biotech Biopharmaceutical Co., Ltd.（\"Kelun-Biotech\"）正在中国开展以下临床试验，以评估CR-001（也称为SKB118）与sacituzumab tirumotecan（\"sac-TMT\"）的联合应用，这是一种靶向TROP2的ADC，还计划进行其他ADC联合研究：

•一项CR-001（SKB118）与sac-TMT联合治疗局部晚期或转移性非小细胞肺癌（NSCLC）的2期试验正在进行中，初步数据预计将于2027年年中公布；

•一项CR-001（SKB118）与sac-TMT联合治疗晚期实体瘤的2期试验正在招募受试者；

•一项CR-001（SKB118）与sac-TMT联合治疗EGFR突变的局部晚期或转移性非鳞状NSCLC的2期试验正在开展，这些患者已接受表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）治疗但失败；以及

•一项CR-001（SKB118）与CR-003（也称为SKB105）联合应用的1/2期试验，CR-003是一种靶向整合素-β6的ADC，预计将于2027年上半年启动。

ADC管线

2026年10月，公司的靶向PD-L1的拓扑异构酶抑制剂ADC药物CR-002获得了美国食品药品监督管理局基于临床试验申请的批准。公司预计将在2026年第四季度启动全球I/II期APOLLO试验，针对包括非小细胞肺癌、头颈鳞状细胞癌以及各种消化道和妇科肿瘤在内的晚期实体瘤患者。预计2027年下半年将公布初步数据。

科伦-Biotech授予公司在美国、欧洲及大中华区以外的所有市场独家研发、生产和商业化靶向整合素-β6的ADC药物CR-003（SKB105）的权利。由科伦-Biotech在中国开展的CR-003（SKB105）针对晚期实体瘤患者的I/II期试验正在进行中，预计2027年第一季度将公布概念验证数据。公司计划利用在中国产生的数据来支持CR-003（SKB105）的全球临床开发。

由科伦-Biotech在中国开展的CR-003（SKB105）针对晚期实体瘤患者的I/II期试验正在进行中，预计2027年第一季度将公布概念验证数据。公司计划利用在中国产生的数据来支持CR-003（SKB105）的全球临床开发。

前瞻性声明

本8-K格式的当前报告中的某些陈述（纯历史信息除外）可能构成联邦证券法意义上的“前瞻性声明”，包括用于

根据1995年《私人证券诉讼改革法案》中的“安全港”条款。这些前瞻性声明包括但不限于关于Crescent对未来产品管线和业务的期望、信念或策略的明确或隐含声明，包括但不限于：CR-001单药治疗和联合试验的临床数据的时间和成功情况；CR-001的III期研究可能启动和成功；CR-001和sac-TMT的II期联合试验的时间和成功情况，包括Kelun-Biotech可能启动的额外ADC联合研究；CR-002全球I/II期APOLLO试验的预计启动时间、试验设计、适应症选择和初步临床数据；由Kelun-Biotech在中国进行的CR-003 I/II期试验的临床数据的时间和成功情况；关于CR-001、CR-002和CR-003的预期益处或机会，包括整个产品组合中预计给药的患者数量；以及CR-002和CR-003作为单药或与CR-001联合使用的潜力。前瞻性声明通常涉及未来事件或未来财务或运营表现。\"相信\"、\"可能\"、\"将\"、\"潜在\"、\"估计\"、\"继续\"、\"预期\"、\"预测\"、\"目标\"、\"打算\"、\"可能\"、\"会\"、\"应该\"、\"计划\"、\"预期\"等类似表述可能标识前瞻性声明，但这些词的缺失并不意味着该声明不是前瞻性声明。这些前瞻性声明基于当前的预期和信念，涉及未来发展的可能性影响，以及可能导致实际业绩与这些前瞻性声明所表达或暗示的业绩有重大差异的若干风险、不确定性和其他假设。风险和不确定性包括但不限于：Crescent与Kelun-Biotech战略合作的预期益处和相关机会可能无法实现，或可能比预期更长时间才能实现；Crescent有限的经营历史，包括临床试验方面；Crescent的历史亏损以及未来产生收入的能力；Crescent筹集资金以支持其业务计划的能力；与临床开发和监管批准相关的风险；与Crescent知识产权相关的风险；Crescent依赖第三方，包括帮助开发其产品候选物、进行临床试验和制造其产品候选物；重大信息技术系统中断或数据安全漏洞、诉讼和监管风险；与当前宏观经济环境相关的风险，包括利率波动、贸易壁垒、财政和货币政策或政府预算动态的变化、地缘政治因素，包括伊朗的持续冲突以及俄罗斯和乌克兰之间的冲突及其应对措施，以及供应链中断，以及在Crescent最近向证券交易委员会提交的文件（包括其截至2026年6月30日的季度报告10-Q）中更详细描述的其他因素，以及Crescent向证券交易委员会提交的其他文件。如果这些风险或不确定性中的任何一个或多个成为现实，或者如果Crescent的任何假设被证明不正确，实际结果可能在重大方面与这些前瞻性声明中所预测的结果不同。本8-K表格中的前瞻性声明仅针对其作出的日期，并完全受本文中的警示性声明的限制。除非法律要求，Crescent不承担或接受公开发布任何前瞻性声明的更新或修订的义务。

签名

根据1934年《证券交易法》（经修订）的要求，注册人已 duly 促使本报告由此处 duly 授权的人员代表其签署。

CRESCENT BIOPHARMA, INC.

日期：2026年10月15日

由：

/s/ Joshua Brumm

姓名：

Joshua Brumm

职位：

首席执行官

","original","zhKind","translation","complete",false,"CBIO","公司与财报","行业与主题","宏观与美联储","政策与监管","观点与解读","其他","aihot","/items/u4ppmssft0ri2k7pfrj1y9zwi","https://www.sec.gov/Archives/edgar/data/1253689/000162828026066006/0001628280-26-066006-index.htm","rss-sec-xbrl","name","SEC · EDGAR 财务披露","rss","firstParty","iconUrl","/api/img-proxy?u=https%3A%2F%2Fwww.sec.gov%2Fthemes%2Fcustom%2Fuswds_sec%2Fassets%2Fimg%2Ffavicons%2Fapple-touch-icon.png&mode=avatar&exp=1792368000&sig=7b6974b5a67903ec","iconSrcSet","/api/img-proxy?u=https%3A%2F%2Fwww.sec.gov%2Fthemes%2Fcustom%2Fuswds_sec%2Fassets%2Fimg%2Ffavicons%2Fapple-touch-icon.png&mode=avatar-48&exp=1792368000&sig=85dc13f192a3fa85 48w, /api/img-proxy?u=https%3A%2F%2Fwww.sec.gov%2Fthemes%2Fcustom%2Fuswds_sec%2Fassets%2Fimg%2Ffavicons%2Fapple-touch-icon.png&mode=avatar-96&exp=1792368000&sig=7b2f7276301ea6d9 96w","changelogVersion","2026-10-01T08:00"]