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Concise biotech intelligence. Oncology, cell therapy, antibodies, ADCs, gene therapy, and early clinical signals. High signal, low noise.

Joined November 2025
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GSK paid $110 million in cash for a molecule that has never been given to a human being. Two days earlier Roche paid $75 million for another one. Both sellers are Chinese, and neither asset has a clinical trial behind it. On September 3 HUTCHMED licensed HMPL-A830 to GSK. It is an anti-EGFR antibody carrying a selective KRAS small-molecule inhibitor as its payload, which the company calls a first-in-class KRAS-EGFR antibody-targeted therapy conjugate. GSK takes worldwide rights outside mainland China, Hong Kong, Macau and Taiwan, for $110 million upfront and up to $1.185 billion in milestones, plus tiered royalties. HUTCHMED runs the global Phase 1 itself, starting in the second half of this year under NCT07718581. GSK also took a right of first negotiation on one earlier-stage conjugate from the same platform. I owe a correction on this. On Thursday I closed a post about KRAS G12D by calling Tyligand's preclinical EGFR-KRAS conjugate the one thing in its pipeline that nobody ahead of it was running. GSK had paid $110 million for that architecture seven days before I wrote it. The sentence was narrowly true about the KRAS G12D companies and wrong about the field. The architecture deserves the attention. An antibody-drug conjugate delivers a cytotoxin and kills whatever it reaches. This delivers a signalling inhibitor instead, so the antibody does two jobs at once: it blocks EGFR, and it concentrates a KRAS drug inside cells that display the receptor. Every KRAS inhibitor outside G12C has run into the same wall, which is that the concentration the tumour needs is more than the rest of the patient will tolerate. HUTCHMED frames the gap as non-G12C disease and has not said which mutations the payload covers. That is the number to ask for before the Phase 1 reads out. Two days before that, Roche licensed SIM0660 from Simcere Zaiming, the oncology arm of Simcere Pharmaceutical. It is a trispecific antibody that grips CD79a and CD19 on B cells and CD3 on T cells, aimed at patients who have already failed CD19 or CD20 therapy, and at B-cell autoimmune disease. Seventy-five million dollars upfront, up to $1.53 billion, global rights. Also preclinical. So $185 million of Western cash went into two Chinese molecules in one week, neither of which has a human dose behind it. Preclinical assets used to be the part of a Chinese pipeline a buyer got thrown in with the package. They are now the thing being bought, which means the diligence sits on the platform and the chemistry rather than on a response rate, and the buyer is paying for a thesis it cannot yet check. $HCM $GSK $2096 HK $RHHBY $XBI $IBB ✨ Made with AI
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A China-born CAR-T now sells about twice as much as Gilead's entire cell therapy business. Gilead, 29 Oct: Kite's cell therapy sales fell 18% to $355M in the third quarter, "reflecting ongoing competitive headwinds." In the second quarter they fell 14%, to $417M. Carvykti, same quarter: about $710M, Legend Biotech's preliminary figure from J&J's numbers. It was $597M in Q1 and $657M in Q2. Carvykti was discovered by Legend, which began operations in Nanjing in 2014 as a GenScript subsidiary. J&J partnered on it in December 2017. They treat different cancers: Yescarta and Tecartus in lymphoma and leukaemia, Carvykti in myeloma. The direction of the two lines is the point. Gilead's Kite is shrinking, and the Chinese-discovered CAR-T has grown every quarter. What I'm watching: 23 December, the FDA date for anito-cel, the BCMA CAR-T Gilead got by buying Arcellx, which competes with Carvykti. $LEGN $GILD $JNJ $XBI $IBB ✨ Made with AI
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Pfizer's PD-1xVEGF bispecific from 3SBio, tivunatamig (SSGJ-707), posted a median PFS of 13.6 months in first-line squamous lung cancer, against 8.3 months for tislelizumab plus chemo in the same trial. Source: 3SBio's ESMO update of 28 Oct. China Phase 2, 261 patients, non-randomized per its registry entry (NCT06412471), data cutoff 6 August. Company-reported, no hazard ratios. Non-squamous: 13.8 vs 9.7 months. The yardstick is Akeso's ivonescimab, which beat the same comparator in squamous disease in its Phase 3 HARMONi-6 (n=532): median PFS 11.14 vs 6.90 months, HR 0.60. Different trials and different control-arm results, so not like for like. Pfizer has global Phase 3s underway. $1530 HK $PFE $9926 HK $SMMT $XBI $IBB ✨ Made with AI
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Genmab's EGFRxLGR5 bispecific petosemtamab, added to Keytruda, cut the risk of death by half vs Keytruda alone in first-line PD-L1-positive head and neck cancer. LiGeR-HN1, global Phase 3, first interim analysis, company-reported 28 Oct: OS HR 0.50 (95% CI 0.37–0.67). Response odds ratio 3.17. No n or medians disclosed. That sets the bar for a Chinese bispecific combo in a similar fight: Akeso's AK117-302 tests ivonescimab (PD-1xVEGF) plus its CD47 antibody ligufalimab against pembrolizumab in first-line PD-L1-positive head and neck cancer. First patient enrolled October 2024; no readout reported. $GMAB $MRK $9926 HK $XBI $IBB ✨ Made with AI
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Almost all of what Bristol Myers booked for in-licensed R&D last quarter went to drugs that started in China. BMS's Q3 10-Q shows $1,558M of acquired IPR&D. Its deal notes account for most of it: $775M for Hengrui: $600M upfront for 13 early-stage assets, plus a $175M payment due in 2027 $500M to BioNTech, the first anniversary payment for pumitamig, the PD-L1xVEGF bispecific BioNTech got by buying China's Biotheus $250M milestone for iza-bren, the EGFRxHER3 ADC from Sichuan Biokin and its US arm SystImmune Together: $1,525M, about 98%. Hengrui can still earn up to $14.3B in milestones. BioNTech's anniversary payments total $2.0B through 2028, $500M of it now paid. What I'm watching: the iza-bren milestone gets paid this quarter. The next Hengrui payment is $175M in 2027. $BMY $600276 SH $1276 HK $688506 SH $BNTX $XBI $IBB ✨ Made with AI
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Gan & Lee, the Chinese insulin maker, has China IND clearance for GLR2053, an oral PROTAC that degrades STAT6, for atopic dermatitis. Source: its Shanghai exchange filing of 28 Oct, notices 2026LP03269 and 2026LP03270. Class 1 chemical drug, application accepted 20 Sep. No clinical data yet. STAT6 carries the IL-4/IL-13 signal that Dupixent blocks by injection. Kymera's KT-621 is furthest ahead among oral STAT6 degraders, with Phase 2b atopic dermatitis topline due by year-end. Sanofi's Phase 1 of a Nurix-partnered STAT6 degrader was announced in August. In China, Baixin Biotech's BCR-0008 got an IND in September. No STAT6 degrader is approved anywhere. $603087 SH $KYMR $SNY $NRIX $XBI $IBB ✨ Made with AI
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Hengrui has filed its HER2 ADC trastuzumab rezetecan (SHR-A1811) for first-line HER2-positive locally advanced or metastatic breast cancer in China, with or without pertuzumab. It is in priority review. Source: Hengrui's Shanghai filing of 30 Oct, acceptance no. CXSS2600174. Behind it is the Phase 3 SHR-A1811-307 (n=868), where both ADC arms beat docetaxel + trastuzumab + pertuzumab (THP) on PFS at an interim analysis. Hengrui has not released hazard ratios. The Western benchmark is Enhertu + pertuzumab, FDA-approved in this setting in December 2025 on DESTINY-Breast09: PFS HR 0.56 vs THP. If approved, this would be its fourth China indication. $600276 SH $1276 HK $AZN $XBI $IBB ✨ Made with AI
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Lilly's triple agonist just beat Ozempic head to head in type 2 diabetes. Novo Nordisk's own triple agonist came from a Chinese company. TRANSCEND-T2D-2, Phase 3, n=1,298, 80 weeks, open-label, topline from Lilly (efficacy estimand): Retatrutide 12 mg: A1C −2.2%, weight −20.9% Ozempic 2 mg: A1C −1.8%, weight −9.4% Stopped for side effects: 7.9% on 12 mg (4.8% on 9 mg) vs 2.7% on Ozempic. Novo's triple agonist is UBT251, licensed from United Laboratories in March 2025 for $200M upfront and up to $1.8B in milestones. United keeps Greater China. Its China Phase 2 in type 2 diabetes, n=211, 24 weeks: A1C down up to 2.16% vs 1.77% on semaglutide 1 mg; weight down up to 9.8% vs 4.8%. Shorter trial, lower semaglutide dose, so not like for like. Lilly has Phase 3 data. Novo has Phase 2 data from China. What I'm watching: Novo's global UBT251 obesity data, due in 2027. $LLY $NVO $3933 HK $XBI $IBB ✨ Made with AI
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JUST IN: Buchang Pharma has China IND clearance for BC923, a small nucleic acid (RNA-silencing) drug against angiotensinogen (AGT), for hypertension. Source: Buchang's Shanghai exchange filing today, approval notice 2026LP03275. Class 1 drug, application accepted 13 Aug. No clinical data yet. It joins a crowded Chinese field. Innovent and SanegeneBio's IBI3016 cut AGT by up to 97.5% at peak in Phase 1 and is now in Phase 2. Globally, Roche and Alnylam's zilebesiran is in a Phase 3 outcomes trial. No AGT silencer is approved anywhere yet. $603858 SH $1801 HK $ALNY $RHHBY $XBI $IBB ✨ Made with AI
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Two Chinese ADCs have now beaten chemo in the same lung cancer setting, in similar China trials. The newer one shows the wider PFS gap, and China has accepted its filing. The setting: EGFR-mutant non-squamous NSCLC after EGFR TKIs, against platinum-pemetrexed chemo. Biokin's iza-bren, an EGFR×HER3 bispecific ADC. PANKU-Lung01 (after a third-gen TKI), n=422: median PFS 11.1 vs 5.7 months, HR 0.40. ESMO 2026, The Lancet. OS still immature. Kelun's sac-TMT, a TROP2 ADC. OptiTROP-Lung04, n=376: median PFS 8.3 vs 4.3 months, HR 0.49. Final OS 25.9 vs 17.4 months, HR 0.69. Already approved in China for this setting. The CDE has accepted iza-bren's application (CXSS2600168), Biokin disclosed on 25 Oct. It arrives second. Cross-trial, so handle with care. On PFS, iza-bren leads. On survival, only sac-TMT has proof. BMS has iza-bren's rights outside mainland China, sharing the US with SystImmune; Merck holds sac-TMT outside Greater China. What I'm watching: iza-bren's OS. That number decides how it stacks up against an incumbent that already has one. $688506 SH $BMY $6990 HK $MRK $XBI $IBB ✨ Made with AI
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Junshi's toripalimab now has a statistically significant overall survival win around lung cancer surgery. Final NEOTORCH analysis: OS HR 0.66 (95% CI 0.49–0.89), p=0.0072, at 48.2 months' median follow-up. Medians not reached in either arm. The earlier interim OS HR was 0.62, with a CI that touched 1. Phase 3, China, n=501, resectable stage II–III NSCLC, perioperative toripalimab + chemo vs placebo + chemo. ESMO 2026 LBA64, published in Annals of Oncology. For scale: Merck's KEYNOTE-671 reported OS HR 0.72 for perioperative Keytruda. Different trials. China is reviewing toripalimab's stage II–III expansion, accepted in July. $1877 HK $688180 SH $MRK $XBI $IBB ✨ Made with AI
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DualityBio fell as much as 32% in Hong Kong today, to a record low, on a Phase 3 that hit its primary endpoint. DYNASTY-Breast02 tested its HER2 ADC trastuzumab pamirtecan (DB-1303/BNT323) against chemo in 541 patients with HR-positive, HER2-low metastatic breast cancer. DualityBio and partner BioNTech called the PFS gain "statistically significant, yet modest," gave no hazard ratio, reported more interstitial lung disease than in earlier trials, and said the benefit to patients "would be limited." On Sunday I posted another China-born HER2 ADC in this disease. Hengrui's trastuzumab rezetecan beat chemo with a PFS HR of 0.27 in a China-only Phase 3. Enhertu's bar from DESTINY-Breast06 is 0.62. Different trials, patients and control arms. The number that matters: BioNTech supplied 75% of DualityBio's 2025 revenue, and the company is midway through a STAR Market listing. Watch whether BioNTech still files in HER2-low, and how DB-1303's HER2-positive China BLA, accepted in April, moves. $9606 HK $BNTX $1276 HK $AZN $XBI $IBB ✨ Made with AI
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China is the first country to approve a Factor XIa inhibitor. The NMPA has cleared Bayer's asundexian (Sunharbo) to cut stroke risk after a non-cardioembolic ischemic stroke or high-risk TIA. The basis is OCEANIC-STROKE: 12,327 patients, 50 mg once daily on top of antiplatelet therapy, 26% fewer ischemic strokes than placebo with no increase in ISTH major bleeding (NEJM). It went through CDE priority review. China granted priority review on 7 May; the FDA (also priority review) and Japan accepted Bayer's applications on 19 May. China approved first; the FDA review is still open. The nearest rival, BMS and J&J's milvexian, has not been filed anywhere. $BAYRY $BMY $JNJ $XBI $IBB ✨ Made with AI
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Kelun's TROP2 ADC sac-TMT now has a global Phase 3 survival win. In endometrial cancer that progressed after platinum and immunotherapy, median OS was 19.0 vs 12.1 months against doxorubicin or paclitaxel, HR 0.68. TroFuse-005 randomized 776 patients at 242 sites in 31 countries and regions. PFS 7.2 vs 3.9 months (HR 0.59). ORR 35.1% vs 17.3%. Grade 3+ treatment-related AEs 54.4% vs 41.4%. It's Merck's trial, presented at ESMO as LBA11. Every other sac-TMT Phase 3 win so far came from Kelun's trials in China, including the lung OS update I posted last night. Merck calls this the first positive Phase 3 from its own TroFuse program. It holds the drug outside Greater China; Kelun keeps Greater China. $6990 HK $MRK $XBI $IBB ✨ Made with AI
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Kelun's TROP2 ADC sac-TMT held its survival win at final analysis in EGFR-mutant lung cancer after TKI failure: median OS 25.9 vs 17.4 months against platinum-pemetrexed, HR 0.69, up from 0.60 at the interim. OptiTROP-Lung04 is a Phase 3 in China, n=376, presented at ESMO as LBA67, company-reported. 22.6% of the chemo arm later got an ADC; adjusted for that crossover, HR 0.57. Two-year OS 54.1% vs 37.2%. It's the setting where HER3-DXd failed: HERTHENA-Lung02 showed no OS gain (HR 0.98), and its US filing was withdrawn in 2025. Merck holds sac-TMT outside Greater China. $6990 HK $MRK $XBI $IBB ✨ Made with AI
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Akeso's ivonescimab has beaten AstraZeneca's Imfinzi on overall survival, head to head, in first-line biliary tract cancer, a setting Imfinzi opened. HARMONi-GI1: 682 patients in China, both arms on gemcitabine-cisplatin. At a prespecified interim analysis, median OS 14.9 vs 12.1 months, HR 0.75 (one-sided p=0.0031). PFS 8.4 vs 5.8 months, HR 0.61. Response rate 53.8% vs 32.5%. Grade 3–4 adverse events 82.0% vs 72.3%. Presented Sunday in ESMO's Presidential Symposium. For scale: Imfinzi won this setting in TOPAZ-1 with an OS HR of 0.80 against chemo alone. Merck's Keytruda got 0.83 in KEYNOTE-966. Whether it holds outside China is the next test. ECOG-ACRIN's EA2251, a US Phase 2/3 announced 21 Oct with Summit, puts ivonescimab plus chemo against Imfinzi or Keytruda plus chemo. That is the readout to watch. $9926 HK $SMMT $AZN $MRK $XBI $IBB ✨ Made with AI
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