FierceBiotechCodex · 实盘不做把握 4/10
北京时间·🕒 发布 01:59:00时区推断·⟳ 抓取 03:05:21·⚡ 决策 07-30 03:06:48 +1m27s·89.5 天前
默克短暂泄露MK-2010与TROP2 ADC联合用药二期试验计划后删除页面
事件只显示MK-2010可能进入与sac-TMT联合用药的二期探索,尚未有启动确认、疗效数据、入组规模或商业化金额。
📄 原文FierceBiotech↗ 原文
Merck posts—then pulls—trial plan for PD-1xVEGF and TROP2 ADC combination
After keeping tight-lipped for nearly two years, Merck & Co. briefly dropped the first concrete hint as to where it int…
不做 默克(MRK.US)
超大市值主标的仅出现被删除的早期二期试验计划线索,未披露试验启动确认、疗效数据、金额或相对市值可量化增量,不做。
不做 中国生物制药(01177.HK)
LaNova授权资产长期正面,但本次只是默克官网短暂条目且已删除,未确认触发里程碑付款或商业化增量;港股当前未开盘,缺少足够edge,不做。
不做 康方生物(06990.HK)
默克潜在竞争仍处早期二期准备阶段,且进度落后于ivonescimab关键性开发,不能构成强空或可执行同向交易,不做。
不做 Summit Therapeutics(SMMT.US)
事件对Summit只是远期竞争提示,缺少明确、强的公司级负面事实;未满足做空红线,不做。
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)
研究档案
消息传播链
- 默克正式宣布以5.88亿美元首付款、最高27亿美元里程碑获得LaNova的LM-299全球权益,说明MK-2010资产本身不是新消息。
- 中国生物制药披露LaNova在AACR展示MK-2010/LM-299早期临床数据,提示该药物已有公开临床进展而非首次曝光。
- Fierce此前已报道默克围绕sac-TMT和MK-2010组合策略保持谨慎,市场已有对组合开发路线的预期讨论。
- FierceBiotech报道默克官网短暂出现MK-2010联合sac-TMT的二期试验条目后删除,PharmCube为较早发现者之一;默克未回应。市场反应:事件发生时美股仍在盘中,但无证据显示MRK或SMMT出现足以确认短线重定价的异常反应。
关键理由
- 事件只显示MK-2010可能进入与sac-TMT联合用药的二期探索,尚未有启动确认、疗效数据、入组规模或商业化金额。
- 对默克(MRK.US)而言这是Keytruda后续管线布局线索,但相对其超大市值和既有肿瘤管线不足以形成短线重定价。
- 对中国生物制药(1177.HK)/LaNova是潜在里程碑正面信号,但网页已删除且只是早期二期计划,距离可确认收入增量仍远。
主要风险
- 若默克后续正式公告MK-2010快速推进关键性试验或披露里程碑付款,1177.HK可能重新具备事件交易价值。
- 若PD-1xVEGF联合TROP2 ADC路径被证实有效,Akeso/Summit等先发者面临长期竞争,但本条信息不足以构成短线做空催化。
反向证据
- 做多前查反向 · 来源 web · 日期 2026-07-29 · 影响 weakens
未找到默克正式确认试验启动或触发里程碑付款,削弱对MRK.US和1177.HK的可交易多头判断。
检索:Merck MK-2010 sac-TMT phase 2 deleted listing confirmed trial start milestone payment 原文 ↗ - 做空前查反向 · 来源 web · 日期 2026-07-29 · 影响 invalidates
报道反而强调默克仍仅在二期边缘、进度落后于Akeso/Summit、BioNTech/BMS和Pfizer/三生制药,不能形成对竞争者的强空催化。
检索:Merck MK-2010 competition Akeso Summit ivonescimab phase 3 behind cautious 原文 ↗ - 做多前查反向 · 来源 web · 日期 2026-04-20 · 影响 weakens
1177.HK已有AACR数据披露和历史授权公告,本次二期计划没有披露新增患者、付款或销售权益兑现,量级暂不可交易。
检索:Sino Biopharmaceutical MK-2010 LM-299 AACR data Merck milestone revenue exposure 原文 ↗
原文全文
展开原文 · 4,334 字
After keeping tight-lipped for nearly two years, Merck & Co. briefly dropped the first concrete hint as to where it intends to take its PD-1xVEGF bispecific antibody—before quietly scrubbing the evidence.
A brief, now-deleted clinical trial listing on Merck’s website revealed that the New Jersey pharma plans to test the bispecific, coded MK-2010, alongside its TROP2-directed antibody-drug conjugate, sac-TMT.
The phase 2 trial, coded MK-2010-003, was marked as “Study in start-up” on Merck’s website with St. Gallen and Bellinzona in Switzerland listed as study centers. The open-label study would test the combo in patients with advanced solid tumors.
Following a request for comment from Fierce Biotech on Wednesday morning, Merck has apparently removed the entry and deleted other listings for MK-2010, including a separate phase 2 monotherapy trial.
The company didn’t reply to Fierce’s inquiry by publication time. China-based life sciences data aggregator PharmCube was among the first to report on the trial entry.
The secrecy underscores a highly competitive race within the PD-(L)1xVEGF bispecific class, which also includes Summit Therapeutics and Akeso’s frontrunner ivonescimab, Bristol Myers Squibb and BioNTech’s pumitamig, and Pfizer and 3SBio’s PF-08634404 (SSGJ-707).
Merck has kept its PD-1xVEGF strategy close to its chest since acquiring the asset from China’s LaNova Medicines (now part of Sino Biopharmaceutical) in 2024, citing a fiercely competitive environment. As bispecifics threaten to unseat Keytruda as the new immuno-oncology backbone, industry watchers and rivals alike have been closely tracking every move by the Keytruda maker while trying to decipher every comment the company makes.
During an investor event on the sidelines of the 2026 American Society of Clinical Oncology annual meeting in June, Merck’s head of oncology global clinical development, Marjorie Green, M.D., pointed to the company’s experience combining Keytruda with VEGF inhibitors. She touted a “portfolio of novel agents that offer combination opportunities oriented towards combinations of the future rather than adding on to today’s current standard, including ADCs like sac-TMT.”
Hints of Merck’s development plan for MK-2010 dropped as questions also begin to swirl around potential competition—rather than synergy—between PD-1xVEGF drugs and TROP2 ADCs in the lucrative non-small cell lung cancer indication. As Akeso has reported ivonescimab head-to-head wins against PD-1 inhibitors in first-line NSCLC, Merck’s partner, Kelun-Biotech, has also delivered strong phase 3 results for sac-TMT in the same setting.
Standing only on the verge of phase 2, Merck’s measured approach to MK-2010 reflects a cautious stance that contrasts sharply with the expansive phase 3 programs underway at BioNTech/BMS and Pfizer, as well as Merck’s own 17-trial roster for sac-TMT.
For pumitamig, BioNTech and BMS have laid out the first wave of nine global pivotal trials across multiple tumor types, with lung cancer and breast cancer leading the way.
In potential combinations of PD-1xVEGF and TROP2 ADC, specifically, Merck also appears to be behind. China’s Minghui Pharmaceutical is already about a year into phase 2 development, pairing its PD-1xVEGF candidate MHB039A with a TROP2 ADC coded MHB036C for advanced breast cancer and other solid tumors.
Despite what appears to be a conservative approach so far, Leerink Partners analyst Daina Graybosch, Ph.D., has argued that Merck could rapidly pivot to more aggressive development of MK-2010 if it so chooses.
“We believe Merck’s ‘wait-and-then-move’ strategy for MK-2010 will prove successful, as they have a strong portfolio to leapfrog the competition via ADC combinations,” Graybosch and colleagues wrote in an April note after Merck unveiled the first clinical data for MK-2010 at the American Association for Cancer Research annual meeting.
“Should Merck proceed with MK-2010 more aggressively, we believe they are likely to leverage their vast ADC program (including […] sac-TMT) to combine with MK-2010,” the team said at the time.
Meanwhile, the oncology field is eagerly waiting for phase 3 readouts from AstraZeneca and Daiichi Sankyo’s Avanzar trial for a cocktail of their TROP2 ADC, Datroway, with AZ’s PD-L1 inhibitor Imfinzi and chemotherapy in first-line NSCLC.
A brief, now-deleted clinical trial listing on Merck’s website revealed that the New Jersey pharma plans to test the bispecific, coded MK-2010, alongside its TROP2-directed antibody-drug conjugate, sac-TMT.
The phase 2 trial, coded MK-2010-003, was marked as “Study in start-up” on Merck’s website with St. Gallen and Bellinzona in Switzerland listed as study centers. The open-label study would test the combo in patients with advanced solid tumors.
Following a request for comment from Fierce Biotech on Wednesday morning, Merck has apparently removed the entry and deleted other listings for MK-2010, including a separate phase 2 monotherapy trial.
The company didn’t reply to Fierce’s inquiry by publication time. China-based life sciences data aggregator PharmCube was among the first to report on the trial entry.
The secrecy underscores a highly competitive race within the PD-(L)1xVEGF bispecific class, which also includes Summit Therapeutics and Akeso’s frontrunner ivonescimab, Bristol Myers Squibb and BioNTech’s pumitamig, and Pfizer and 3SBio’s PF-08634404 (SSGJ-707).
Merck has kept its PD-1xVEGF strategy close to its chest since acquiring the asset from China’s LaNova Medicines (now part of Sino Biopharmaceutical) in 2024, citing a fiercely competitive environment. As bispecifics threaten to unseat Keytruda as the new immuno-oncology backbone, industry watchers and rivals alike have been closely tracking every move by the Keytruda maker while trying to decipher every comment the company makes.
During an investor event on the sidelines of the 2026 American Society of Clinical Oncology annual meeting in June, Merck’s head of oncology global clinical development, Marjorie Green, M.D., pointed to the company’s experience combining Keytruda with VEGF inhibitors. She touted a “portfolio of novel agents that offer combination opportunities oriented towards combinations of the future rather than adding on to today’s current standard, including ADCs like sac-TMT.”
Hints of Merck’s development plan for MK-2010 dropped as questions also begin to swirl around potential competition—rather than synergy—between PD-1xVEGF drugs and TROP2 ADCs in the lucrative non-small cell lung cancer indication. As Akeso has reported ivonescimab head-to-head wins against PD-1 inhibitors in first-line NSCLC, Merck’s partner, Kelun-Biotech, has also delivered strong phase 3 results for sac-TMT in the same setting.
Standing only on the verge of phase 2, Merck’s measured approach to MK-2010 reflects a cautious stance that contrasts sharply with the expansive phase 3 programs underway at BioNTech/BMS and Pfizer, as well as Merck’s own 17-trial roster for sac-TMT.
For pumitamig, BioNTech and BMS have laid out the first wave of nine global pivotal trials across multiple tumor types, with lung cancer and breast cancer leading the way.
In potential combinations of PD-1xVEGF and TROP2 ADC, specifically, Merck also appears to be behind. China’s Minghui Pharmaceutical is already about a year into phase 2 development, pairing its PD-1xVEGF candidate MHB039A with a TROP2 ADC coded MHB036C for advanced breast cancer and other solid tumors.
Despite what appears to be a conservative approach so far, Leerink Partners analyst Daina Graybosch, Ph.D., has argued that Merck could rapidly pivot to more aggressive development of MK-2010 if it so chooses.
“We believe Merck’s ‘wait-and-then-move’ strategy for MK-2010 will prove successful, as they have a strong portfolio to leapfrog the competition via ADC combinations,” Graybosch and colleagues wrote in an April note after Merck unveiled the first clinical data for MK-2010 at the American Association for Cancer Research annual meeting.
“Should Merck proceed with MK-2010 more aggressively, we believe they are likely to leverage their vast ADC program (including […] sac-TMT) to combine with MK-2010,” the team said at the time.
Meanwhile, the oncology field is eagerly waiting for phase 3 readouts from AstraZeneca and Daiichi Sankyo’s Avanzar trial for a cocktail of their TROP2 ADC, Datroway, with AZ’s PD-L1 inhibitor Imfinzi and chemotherapy in first-line NSCLC.
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