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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.
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Boan Biotech has China clearance to start human trials of BA2201, a TL1A x IL-23p19 bispecific for inflammatory bowel disease. Announced 6 Nov; the IND was accepted in August.
The plan: a randomized, double-blind, placebo-controlled Phase I/IIa, dosed under the skin, in healthy volunteers and patients with moderate-to-severe ulcerative colitis. Boan says monkey half-life suggests dosing every three months may be possible. No human data yet.
Same target pair as Caldera's CLD-423 (from Qyuns, in Phase 1 in Australia and China) and InnoCare's ICP-B161, first dosed in China on 30 Oct. That makes at least three China-origin IL-23 x TL1A bispecifics in or entering the clinic.
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AusperBio's hepatitis B antisense drug AHB-137: in the NA-treated cohort, functional cure held in 16 of 17 evaluable patients 12 months after stopping all HBV treatment, and in 9 of 9 at 15 months.
Company-reported AASLD 2026 data, oral presentations on 8 Nov. NA-treated cohort of 34 (21 complete responders). In treatment-naive patients, 6 of 7 complete responders held through 15 months; one rebounded. The evaluable count shrinks with follow-up, and safety is described only in words (no severe flares or new signals), with no figures.
Why it matters: GSK's bepirovirsen is the same drug class, an antisense oligonucleotide. AusperBio, a venture-backed China/US company, already has a Phase 3 running in China.
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Pfizer's PD-1xVEGF bispecific from 3SBio posted 13.6 months median PFS in squamous lung cancer, company-reported.
Carvykti sold $710M last quarter, twice Kite's whole cell therapy business.
Lilly says Mounjaro's China reimbursement listing drove most of a 29% drop in its prices outside the US.
Kite's next-generation lymphoma CAR-T, KITE-753, is on a partial clinical hold.
Leads Biolabs dosed the first lupus patient with LBL-047, licensed to Dianthus outside Greater China.
Link in the reply.
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A Hong Kong biotech has now licensed two TL1A bispecifics to the same US startup, and it owns part of the buyer.
On 5 Nov Qyuns Therapeutics licensed worldwide rights to a preclinical TL1A x IL-17 bispecific to Caldera Therapeutics. Caldera's release confirms the deal; I'm not quoting the money until I've read Qyuns' own HKEX filing.
The first deal, April 2025, was QX030N, an IL-23p19 x TL1A bispecific that is now Caldera's lead, CLD-423. Qyuns took $10M upfront and an equity stake in Caldera. Caldera's Phase 1a, released the same day: IV half-life above 40 days in 56 healthy volunteers, no dose-limiting toxicities.
The front-runners are single-target: Merck's tulisokibart and Roche's afimkibart, both TL1A antibodies in Phase 3. Caldera's bet is that pairing TL1A with a second target beats them. It plans to go public through a merger with about $278M in new financing, closing early 2027.
So Qyuns gets paid three ways: cash, milestones, and stock in the company carrying its molecules. What I'm watching: the first human data on the IL-17 asset.
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Adding Brii Bio's therapeutic vaccine and an siRNA to interferon more than doubled hepatitis B surface antigen loss: 25.5% (25 of 98) vs 10.2% (5 of 49) on interferon alone at end of treatment, p=0.0301.
Late-breaking AASLD data released 5 Nov, Phase 2 ENHANCE, company-reported, virologically suppressed adults. 24 weeks off treatment: 17.3% vs 6.1%. In patients starting above 1,000 IU/mL HBsAg: 8 of 33 vs 0 of 18.
The siRNA is elebsiran, licensed from Vir for Greater China in 2020.
Why it matters: the control is interferon alone, the existing finite-course route to functional cure that any new regimen would have to beat in China.
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Antengene has dosed the first patient with ATG-201, a CD19xCD3 T-cell engager, in B cell-driven autoimmune disease. Announced 6 Nov.
Phase 1 ATTRACT: dose escalation, then expansion, in China and Australia. Company release; no n, registry number or dosing date given. Lead investigator: Zhanguo Li, Peking University People's Hospital.
UCB holds worldwide rights to develop, make and sell it, so a China-run Phase 1 is now generating the first human data for a Belgian pharma's asset.
The read-through: off-the-shelf CD19 engagers are the alternative to autologous CAR-T in autoimmunity, where Novartis has paused its autoimmune CAR-T trials since late August after three patient deaths.
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Lynk Pharmaceuticals has filed its oral JAK1 inhibitor zemprocitinib in China for rheumatoid arthritis after biologics fail. The CDE accepted the NDA on 4 Nov.
The evidence: a China Phase 3, double-blind, placebo-controlled, n=430, in patients with inadequate response or intolerance to biologic DMARDs. Company-reported: primary and key secondary endpoints met, p<0.0001, with no arm-level numbers released. On 76 weeks of continuous treatment: ACR20 91.8%, ACR50 80.5%, ACR70 62.4%, denominator not given.
Lynk is private, with a Hong Kong listing application pending; Simcere holds exclusive China commercial rights in rheumatology. An atopic dermatitis NDA has been under review since April.
Why it matters: biologic failures are the population AbbVie tested Rinvoq, also a selective JAK1, in SELECT-BEYOND. China is getting a domestic option for the same patients.
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Akeso's PD-1xVEGF bispecific ivonescimab, given with chemo before surgery, left no viable cancer cells in the removed tumour and lymph nodes in 43% of lung cancer patients. Keytruda's Phase 3 did it in 18%.
The full paper is out this week in Nature Medicine: a China Phase 2 of ivonescimab plus platinum-paclitaxel before surgery, then ivonescimab alone after, in resectable stage II-IIIB NSCLC. Pathological complete response 43.0% of all 79 enrolled, 50.7% (34 of 67) of those who reached surgery. Major pathological response 70.1%. 12-month EFS 83.3%. No grade 3+ bleeding.
The benchmarks, all patients randomized: KEYNOTE-671, pembrolizumab plus chemo, pCR 18.1%. CheckMate 816, nivolumab plus chemo, 24.0%.
The caveats: non-randomized, 78.5% squamous, 81.0% stage III. Those Phase 3s were randomized with mixed histology, and pCR is not survival.
Summit holds the rights in the US, Canada, Europe, Japan, Latin America, the Middle East and Africa. What I'm watching: a randomized perioperative trial. Until one reads out, 43% is a non-randomized ceiling.
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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.
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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.
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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.
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China just approved its 10th CAR-T. A CD19 rival approved in 2021 sold RMB 111M in the first half of this year.
Imunopharm (艺妙神州, also written Immunochina) has NMPA approval for IM19, an autologous CD19 CAR-T, in adults with r/r large B-cell lymphoma after two or more lines. The company announced it on 5 Nov; a Chinese daily monitor citing the NMPA list dates approval to 3 Nov. The count is Insight's: nine CAR-Ts before this. I found no English coverage.
Company-reported pivotal data, n=96: 3-month ORR 58.3%, best ORR 72.9%, median PFS 5.98 months, grade 3+ CRS 1.0%, no grade 3+ ICANS. I haven't seen a paper.
Huadong Medicine holds the mainland rights under a 2024 deal worth up to RMB 1.075B, and already sells CARsgen's BCMA CAR-T, zevor-cel.
Chinese trade press names four CD19 CAR-Ts already in this disease. One is JW Therapeutics' relma-cel: RMB 111.2M in H1 2026, up 36.9%, and 99.9% of JW's revenue.
Imunopharm's STAR Market application went from inquiry to suspended on 30 Sep. The report gives no reason; 58 IPOs got that status that day, flagged for financial-report updates. I couldn't confirm this one is among them.
What I'm watching: the 2026 NRDL list, expected this month. JW and Juventas both bid their CAR-Ts for basic coverage. A listing would reset the price IM19 has to answer.
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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.
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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.
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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.
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A survival win has now spent three and a half years at the FDA without an approval. On 4 Nov the fourth application got a new date, 9 April 2027, and HLB fell about 20% in morning trade.
Hengrui's filing that day: the FDA accepted its resubmitted BLA for camrelizumab, paired with apatinib (rivoceranib in the West), in first-line liver cancer. Camrelizumab-related R&D so far: about RMB 3.53B, unaudited. The filing names FDA inspection timing and outcome as a risk.
HLB of Korea, parent of rivoceranib's US applicant Elevar, told investors last month it saw a Class 1 review: two months, a decision in 2026. The FDA chose Class 2: six months. HLB traded near 32,600 won that morning.
The July CRL, per Elevar, raised no new concerns on CARES-310: OS 23.8 vs 15.2 months against sorafenib, HR 0.64, n=543. Three CRLs since May 2024, all tied to manufacturing findings at Hengrui sites; the first also cited unfinished clinical-site inspections. The site in July's letter got a VAI close-out days later.
So HLB holders lost about a fifth of their value in a morning over a longer FDA clock, on an application whose open question sits in Chinese plants HLB doesn't run. HLB says the FDA hasn't asked for more efficacy data, and that a CMC inspection is the only step left.
What I'm watching: that inspection, before 9 April.
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