BioSignal

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

Hengrui has China clearance to test its HER2 ADC trastuzumab rezetecan (SHR-A1811) with a PD-1/PD-L1 inhibitor around surgery, in resectable non-squamous lung cancer with HER2 abnormalities. Source: filing no. 2026-170, signed 4 Nov, acceptance CXSL2600810. The same filing lists a notice for Hengrui's PD-L1 adebrelimab, CXSL2600811. No phase, n or design given. The ADC's lung label today is HER2-mutant disease after at least one systemic therapy. So in lung, the ADC is moving from later-line toward curative-intent treatment. An investigator-led neoadjuvant Phase 2 with adebrelimab (NCT07281209, n=40) is already registered. Cumulative R&D on the ADC: about RMB 2.36B, unaudited. The filing puts 2025 global sales of four HER2 ADCs, Enhertu among them, at about $8.16B. $600276 SH $1276 HK $AZN $DSNKY $XBI $IBB ✨ Made with AI

BeOne's US Brukinsa sales last quarter, about $1.0B, were roughly nine times Zai Lab's whole revenue. Both reported on 5 Nov. BeOne: Q3 revenue $1.89B, up 34%; GAAP net income $385M; 2026 revenue guidance raised to $6.9-7.0B from $6.6-6.8B. Global Brukinsa $1.4B, Tevimbra $243M. Zai: Q3 revenue $108.2M vs $116.1M; net loss $46.1M, with $13.6M of inventory write-downs. It sells licensed drugs mainly in China and says that business returns to growth in 2027. Zai's bet is outside China: its DLL3 ADC zoci, with a global Phase 3 in first-line small cell lung cancer due to start by year-end, and a possible first US BLA in 2027. It raised $250M in October at $22.04 per ADS. What I'm watching: zoci's Phase 3 start, then whether the interim from DLLEVATE, its Phase 3 in second-line-plus SCLC, lands in 2H 2027. $ONC $ZLAB $XBI $IBB ✨ Made with AI

Ascentage's first clinical look at its oral EED inhibitor APG-5918: ORR 44.7% in r/r T-cell lymphoma (21 of 47, 2 CRs), and 65.0% at the 600 mg daily dose it chose for Phase 2 (n=20, CR 10%). Source: the 4 Nov ASH preview; oral #513 on 13 Dec. First-in-human Phase 1, US and China, company-reported, enrollment cutoff 30 July. No DLTs; grade 3+ treatment-related events mainly hematologic. DOR and PFS not reached. The yardstick is Daiichi Sankyo's valemetostat, an EZH1/2 inhibitor on the same PRC2 complex. Lancet Oncology, Phase 2, r/r PTCL: ORR 44% (52 of 119), CR 14%, median DOR 11.9 months. Different populations, and 20 patients at one dose is thin. What I'm watching: durability at the December oral. $AAPG $6855 HK $DSNKY $XBI $IBB ✨ Made with AI

Aosaikang has filed ASKB589 (omectatug), its CLDN18.2 antibody, in China for first-line gastric cancer, on a Phase 3 it says hit PFS. Acceptance no. CXSS2600184, announced 4 Nov. Chinese trade press calls it the first domestic CLDN18.2 antibody to file. The Phase 3 added it to BeOne's tislelizumab plus CAPOX, against placebo on the same backbone. Company statement: statistically significant IRC-assessed PFS, consistent benefit on OS. No HR, months or n disclosed. The ESMO 2025 Phase Ib/II (62 enrolled, PD-1 plus CAPOX): 47 stage IV moderate-to-high expressers had cORR 76.1%, median PFS 12.45 months. Astellas' Vyloy, the first approved CLDN18.2 antibody, carries its China label with chemo. A PD-1 combination filing would test a different backbone in overlapping patients. China also has CARsgen's later-line CAR-T approved and CLDN18.2 ADCs under review. What I'm watching: the Phase 3 hazard ratio. $002755 SZ $ALPMY $ONC $2171 HK $XBI $IBB ✨ Made with AI

Legend Biotech's in-vivo CAR-T LB2501: all 8 patients at dose level 2 have reached complete response, per its 4 Nov ASH preview. June's set (1 April cutoff) was 5 of 6. Company-reported, China Phase 1 (NCT07002112), r/r B-cell lymphoma, responses lasting up to five months. The release gives no cutoff date and no LB2501 safety numbers; poster #4169 comes on 13 Dec. June's set: no lymphodepleting chemo, DL2 CRS in 6 of 6, all grade 1-2, no ICANS, and 0 of 6 responses at the lower dose. Eight patients and five months is still thin. The number to look for in December: how many of the 8 are still in CR. $LEGN $XBI $IBB ✨ Made with AI

JUST IN: Hinova licensed its oral VAV1 molecular glue HP570 (EVO570 at Evommune) outside Greater China: $30M upfront, up to about $1.07B in milestones, royalties from mid-single to low-double digits. Chinese headlines say $30M. Evommune's 8-K of 4 Nov splits it: $20M cash plus pre-funded warrants on 1,262,413 shares, valued at $10M on a 45-day average implying about $7.92. Evommune's last price that day was $6.04, the price at which it agreed to sell $30M of stock to investors. Hinova can instead ask for cash at 90% of that average, about $9M. The benchmark: Novartis paid Monte Rosa $150M upfront and up to $2.1B in milestones in October 2024 for MRT-6160, then in Phase 1, now in Phase 2. Different structures: Novartis took worldwide rights with a US profit share. Hinova got a fifth of that upfront with no reported human data: IND accepted in the US, submitted in China, first Phase 2 in rheumatoid arthritis planned for 2027. $688302 SH $EVMN $GLUE $NVS $XBI $IBB ✨ Made with AI

JUST IN: Minghui Pharmaceutical licensed Japan rights to its subcutaneous IGF-1R antibody MHB018A to Tokyo's ASKA Pharmaceutical: $110M upfront, up to $330M in milestones, tiered royalties up to the mid-30% range on Japanese net sales. Source: the companies' 4 Nov release. Minghui keeps everything outside Japan and leads global development, with four randomized pivotal studies in thyroid eye disease, two in China and two global. This release gives no Phase 2 numbers; Minghui's June ENDO release reported 81% proptosis response in active TED at Week 12 (N=32), and I saw no placebo arm mentioned. The yardstick is Viridian's July 2025 Japan deal with Kissei for veligrotug and VRDN-003: $70M upfront, up to $315M in milestones, royalties from 20% to the mid-30s. Minghui got more upfront, for one drug. Amgen's IV Tepezza won Japan approval in September 2024. What I'm watching: the China Phase 3 readout in active TED, which a December 2025 report guided for summer 2026. I found none. $4886 JP $VRDN $AMGN $XBI $IBB ✨ Made with AI

Dizal's Q3 net profit was RMB 3.85B, on one payment. Allist's was RMB 792M, selling pills. Dizal's Q3 report of 30 Oct, unaudited: revenue RMB 4.25B, up 1,736%, with AstraZeneca's $600M upfront for sunvozertinib recognised in the period. Nine-month revenue was RMB 4.77B. Allist's Q3 report of 28 Oct, unaudited: revenue RMB 1.82B, up 33.6%, net profit up 40.4%, RMB 768M ex-non-recurring. Furmonertinib sold RMB 4.85B in nine months. Sinolink's sample of 133 pharma names, per Daily Economic News on 4 Nov: nine-month revenue up 1%, net profit up 52%, Q3 net profit up 95%, the Q3 jump mainly on out-licensing revenue. What I'm watching: Dizal's Q4, with no upfront and only whatever AstraZeneca milestones or royalties land. $688192 SH $688578 SH $AZN $XBI $IBB ✨ Made with AI

Gan & Lee's revenue outside China rose 60.38% to RMB 572M in the first nine months. Inside China it rose 3.96% to RMB 2.80B. Source: Q3 report of 28 Oct, unaudited. Product sales abroad were RMB 474M, up 34.36%, with RMB 183M from the Brazil PDP project. Licensing income rose about RMB 94M on bofanglutide deals in Latin America, India and South Korea. The report adds that the €62M upfront for Europe arrived in October, after the period closed. Gan & Lee's 11 Aug filing names Menarini: overweight and obesity only, 39 European countries and regions, up to €664M in milestones. I found no approval yet for bofanglutide, its biweekly GLP-1. The China NDA, for weight management, was reported accepted on 2 Sep. $603087 SH $XBI $IBB ✨ Made with AI

uniQure's Huntington's gene therapy has an FDA date: 1 May 2027, under priority review. The FDA tentatively plans an adcom. Source: uniQure's release of 2 Nov. The accelerated-approval BLA rests on 36-month Phase I/II data against a propensity-matched Enroll-HD control. The 48-month readout came after filing and isn't in it: high-dose cUHDRS slowing 44% against an updated control, n=12, p=0.144, not significant; TFC slowing 61%, nominal p=0.008. uniQure argues missing data in the control understated the effect. An adcom could put external controls for brain-delivered AAV on public trial. China has an earlier program in the same brain region: Kanglin's KL002 gene therapy in Parkinson's, injected into the putamen by viral vector, cleared an IND last week per a 医药观澜 round-up of CDE data. I haven't read the CDE entry, and nothing I've seen shows an external-control plan. $QURE $XBI $IBB ✨ Made with AI