The PD-(L)1 x VEGF Bispecific Race: Every APAC Programme in the Clinic, Counted

16 October 2026 | Friday | Analysis

Thirteen molecules, six in Phase 3, five being tested head-to-head against pembrolizumab. Ten days before ESMO opens in Madrid, we tally the drug class Asia invented and the West is now paying to own.

The race chart: furthest registered stage per molecule. Orange diamonds mark a Phase 3 run directly against pembrolizumab.

When the ESMO Congress opens in Madrid on 23 October, one drug class will be hard to miss. Two days in, on the evening of Sunday 25 October, the Presidential Symposium will hear HARMONi-GI1, Akeso's Phase 3 trial of ivonescimab plus chemotherapy against durvalumab plus chemotherapy in first-line biliary tract cancer. Akeso has already said the trial met its overall survival endpoint at a prespecified interim analysis. The next morning, Pfizer and 3SBio will post updated Phase 2 lung cancer data for tivunatamig, the molecule Pfizer paid US$1.25 billion to license. Three weeks after that, on 14 November, the US Food and Drug Administration is due to rule on Summit Therapeutics' application for ivonescimab in EGFR-mutant lung cancer.

Those three dates sit inside a larger story. Bispecific antibodies that block PD-1 or PD-L1 with one arm and the blood-vessel growth factor VEGF with the other are the most heavily licensed drug class to come out of Asia-Pacific in this cycle. Almost every clinical-stage molecule in the class traces back to China. Pfizer, Bristol Myers Squibb, AbbVie and Merck & Co now hold rights to APAC-born molecules, and AstraZeneca bought its way in on 28 September with a US$2.0 billion equity investment in Summit.

So we counted. This tracker lists every APAC-originated PD-1 or PD-L1 x VEGF bispecific with a registered clinical trial, who holds which territories, which have reached Phase 3, and which have chosen to fight the world's best-selling cancer drug, pembrolizumab (Keytruda), head-on. We intend to rerun it every year.

APAC molecules with a registered trial

with a Phase 3 under way or completed

in Phase 3 head-to-head vs pembrolizumab

14 Nov

FDA action date for ivonescimab

How we counted

Inclusion: a bispecific antibody (including antibody fusion formats) that binds PD-1 or PD-L1 and VEGF, originated by a company headquartered in Asia-Pacific, with at least one registered interventional trial on ClinicalTrials.gov, China's CDE drug trial registry or ChiCTR, or a company disclosure that dosing has begun.

Excluded: trispecifics (such as PD-1 x CTLA-4 x VEGF constructs), antibody-drug conjugates, preclinical assets, and molecules originated outside the region even where an APAC company holds local rights.

Stage: the most advanced registered trial. Licence economics are reported only from regulatory filings or company releases; undisclosed terms are marked as such and never estimated.

Data cut: 13 October 2026. Identifiers were checked against registry records and company releases; readers should treat trial-status fields as a snapshot.

The roster at a glance

Molecule	Target pair	Rights outside originator	Stage	Phase 3 comparator(s)
Ivonescimab (AK112)	PD-1 x VEGF	Summit: US, Canada, Europe, Japan, Latin America, Middle East, Africa	Approved (China)	Pembrolizumab; pembrolizumab + chemo; tislelizumab + chemo; durvalumab + chemo
Tivunatamig (SSGJ-707)	PD-1 x VEGF	Pfizer: global ex-China, with China option	Phase 3	Pembrolizumab + chemo; pembrolizumab; bevacizumab + chemo
Pumitamig (BNT327)	PD-L1 x VEGF	BioNTech (owner), co-developed with BMS	Phase 3	Pembrolizumab + chemo; pembrolizumab; durvalumab
RC148 (ABBV-1480)	PD-1 x VEGF	AbbVie: ex-Greater China	Phase 3	Tislelizumab + chemo
SCTB14	PD-1 x VEGF	None	Phase 3	Pembrolizumab
HB0025	PD-L1 x VEGF	None	Phase 3	Pembrolizumab + chemo
IMM2510	PD-L1 x VEGF	None (Instil/Axion licence ended Jan 2026)	Phase 2	Phase 3 applications reported
JS207	PD-1 x VEGF	None	Phase 2	Phase 2/3 vs nivolumab cleared by FDA
MHB039A	PD-1 x VEGF	None	Phase 2	None
AP505 / B1962	PD-L1 x VEGF	Tasly: Greater China	Phase 2a	None
MK-2010 (LM-299)	PD-1 x VEGF	Merck & Co: global	Phase 1/2	None disclosed
CVL006	PD-L1 x VEGF	None	Phase 1/2	None
HLX37	PD-L1 x VEGF	None	Phase 1	None

Approved: the benchmark

1. Ivonescimab (AK112 / SMT112)

Originator	Akeso (China)
Licensee and territory	Summit Therapeutics: US, Canada, Europe and Japan (December 2022: US$500 million upfront, up to US$5.0 billion total), extended to Latin America, the Middle East and Africa in June 2024 (US$15 million upfront, up to US$55 million in milestones). Akeso retains China and the rest of the world.
Most advanced trial	Approved by China's NMPA in three lung cancer indications (May 2024, April 2025, August 2026). US BLA under review based on HARMONi (NCT06396065).
Comparator	HARMONi-2 (NCT05499390) vs pembrolizumab; HARMONi-3 (NCT05899608) vs pembrolizumab + chemo; HARMONi-7 (NCT06767514) vs pembrolizumab in PD-L1 high; HARMONi-6 vs tislelizumab + chemo; HARMONi-GI1 (NCT06591520) vs durvalumab + chemo
Next readout	HARMONi-GI1, ESMO LBA8, 25 October. FDA action date 14 November. HARMONi-3 squamous PFS guided for second half of 2026; non-squamous PFS first half of 2027.
Note	Five of 16 announced Phase 3s have read out positive, per Summit.

Every other molecule in this tracker is measured against ivonescimab, and for good reason. It is the only one with a regulatory approval and the only one with a completed Phase 3 against pembrolizumab. In HARMONi-2, ivonescimab monotherapy cut the risk of progression or death by 49% versus pembrolizumab in first-line PD-L1-positive lung cancer (median PFS 11.1 versus 5.8 months), and at WCLC in September Akeso reported a statistically significant overall survival result: hazard ratio 0.73, with median survival of 30.8 months against 22.6. HARMONi-6 added a win over tislelizumab plus chemotherapy in squamous disease, including an interim OS hazard ratio of 0.66.

The caveat is geography. HARMONi-2 and HARMONi-6 were China-only trials, and the global HARMONi study that underpins the US filing hit on progression-free survival (HR 0.52) but missed statistical significance on overall survival (HR 0.79, p = 0.057), although an update in July moved the figure to 0.76. That is why HARMONi-3, the global head-to-head against pembrolizumab plus chemotherapy, is the single most watched readout in the class. Summit says the squamous cohort's PFS events land in the second half of this year.

Phase 3: five challengers

2. Tivunatamig (SSGJ-707 / PF-08634404)

Originator	3SBio, through subsidiary Shenyang Sunshine Pharmaceutical (China)
Licensee and territory	Pfizer: global ex-China, with an option on China for up to US$150 million. US$1.25 billion upfront, up to US$4.8 billion in milestones, plus a US$100 million equity investment (Pfizer, May and July 2025).
Most advanced trial	Phase 3 Symbiotic-Lung-01 (NCT07222566), first-line NSCLC, about 1,410 patients; China Phase 3 (NCT06980272), about 420 patients; Symbiotic-GI-03 (NCT07222800), first-line colorectal
Comparator	Pembrolizumab + chemo (global); pembrolizumab (China); bevacizumab + chemo (colorectal)
Next readout	ESMO poster 2660P, updated Phase 2 NSCLC data, 26 October. No Phase 3 timing guided.
Note	3SBio's 2026 interim release refers to a US$1.4 billion upfront received, which matches the base payment plus the full option amount; Pfizer has not separately announced an exercise.

Pfizer is building the broadest pembrolizumab confrontation outside Akeso. It is running two head-to-head lung studies at once, one global and one in China, and has flagged a further Phase 3 combining tivunatamig with its own ADC, enfortumab vedotin, in urothelial cancer. 3SBio reports nine trials worldwide on the asset.

3. Pumitamig (BNT327 / PM8002)

Originator	Biotheus (China); acquired by BioNTech in a deal announced November 2024 (US$800 million upfront, up to US$150 million in milestones)
Licensee and territory	BioNTech holds global rights; Bristol Myers Squibb co-develops and co-commercialises with a 50:50 global cost and profit split (June 2025: US$1.5 billion upfront, US$2.0 billion in non-contingent anniversary payments through 2028, up to US$7.6 billion in milestones)
Most advanced trial	Global ROSETTA Phase 3 programme including Lung-02 (NCT06712316), Lung-202 (NCT07361510), Lung-201 (NCT07361497), Lung-01 (NCT06712355); China Phase 3s in TNBC (NCT06419621) and second-line SCLC (NCT06616532)
Comparator	Pembrolizumab + chemo (Lung-02); pembrolizumab (Lung-202, PD-L1 at least 50%); durvalumab (Lung-201)
Next readout	China first-line TNBC Phase 3 in 2026; global Lung-01 in 2028, Lung-02 and Breast-01 in 2029 (BioNTech guidance)
Note	The only PD-L1-based molecule with a global Phase 3 against pembrolizumab

Pumitamig is the class's clearest test of whether targeting PD-L1 rather than PD-1 matters. BioNTech's timelines are also the most candid in the class about how far away global proof is: the pivotal lung readouts sit in 2028 and 2029.

4. RC148 (ABBV-1480)

Originator	RemeGen (China)
Licensee and territory	AbbVie: ex-Greater China; RemeGen retains Greater China. US$650 million upfront, up to US$4.95 billion in milestones, tiered royalties (January 2026; effective 10 March 2026)
Most advanced trial	China Phase 3 in first-line squamous NSCLC (NCT07416474), first patient dosed May 2026; non-squamous Phase 3 registered (NCT07829549); FDA has cleared INDs for two US Phase 3s in NSCLC
Comparator	Tislelizumab + chemo (China squamous study); US comparators not yet disclosed
Next readout	Not guided
Note	CDE breakthrough therapy designation in NSCLC (August 2025)

Our out-licensing roster, The Out-Licensing Class of 2025 to 2026, set the SSGJ-707 and RC148 deals side by side as the only like-for-like pair among that year's APAC transactions; that analysis of how the two were structured stands, and we do not rerun it here. What the tracker adds is that RemeGen chose BeOne Medicines' tislelizumab, not pembrolizumab, as its China comparator, a choice that echoes Akeso's HARMONi-6.

5. SCTB14

Originator	Sinocelltech (China)
Licensee and territory	None disclosed
Most advanced trial	Phase 3 monotherapy study, CTR20254727 / NCT07362459, first-line driver-negative NSCLC with PD-L1 TPS of at least 10%, about 246 patients
Comparator	Pembrolizumab (primary endpoint PFS by blinded central review)
Next readout	Not guided
Note	Also in Phase 2/3 with chemotherapy in NSCLC (CTR20251153, CTR20250935)

6. HB0025

Originator	Huabo Biopharm (Shanghai), a Huahai Pharmaceutical subsidiary
Licensee and territory	None disclosed
Most advanced trial	Phase 3 DUALIGHT-02, CTR20260016, first-line squamous NSCLC, about 480 patients; first patient dosed 23 January 2026
Comparator	Pembrolizumab + chemo
Next readout	Not guided
Note	PD-L1 x VEGF format; end-of-Phase 2 package filed in endometrial cancer

SCTB14 and HB0025 are the quiet story of the count. Neither has a Western partner, yet both have registered Phase 3s that take on pembrolizumab directly. A positive China readout against the global standard of care is precisely the asset that business development teams have been paying for, and both companies have kept their ex-China rights.

Phase 2 and earlier: the second wave

7. IMM2510

Originator	ImmuneOnco Biopharmaceuticals (China)
Licensee and territory	None. Instil Bio's subsidiary Axion licensed ex-Greater China rights in August 2024 (US$10 million upfront within up to US$50 million in upfront and near-term payments); it discontinued development and rights reverted in January 2026
Most advanced trial	Phase 2 in China; Phase 3 applications in IO-resistant NSCLC reported filed with the CDE in October 2025 (registry identifiers not yet confirmed)
Comparator	Not disclosed
Next readout	Not guided
Note	The only Western licence in the class to have been handed back

8. JS207

Originator	Junshi Biosciences (China)
Licensee and territory	None; Junshi has said it is in discussions with overseas companies
Most advanced trial	Eleven Phase 2 studies, including first-line colorectal with XELOX (NCT06885385) and first-line liver cancer with JS007 (NCT06954467); FDA cleared a Phase 2/3 neoadjuvant NSCLC study
Comparator	Nivolumab (neoadjuvant Phase 2/3)
Next readout	Phase 3 start planned within 2026
Note	AACR 2026: ORR 71.0% in first-line colorectal, 45.5% in first-line liver cancer (Phase 2, early data)

9. MHB039A

Originator	Minghui Pharmaceutical (China)
Licensee and territory	None disclosed
Most advanced trial	Phase 2 in NSCLC combined with Minghui's TROP-2 ADC MHB036C (first patient May 2025); Phase 1 NCT06345482
Comparator	None
Next readout	Not guided
Note	An in-house bispecific plus ADC pairing, the combination model big pharma is now pursuing

10. AP505 / B1962

Originator	AP Biosciences (Taiwan)
Licensee and territory	Tasly Biopharmaceuticals: mainland China, Hong Kong and Macau; a March 2026 amendment sets revenue sharing for ex-China licensing, terms undisclosed
Most advanced trial	Phase 2a in advanced solid tumours (NCT06724263); Phase 1 NCT05650385 and NCT06723964
Comparator	None
Next readout	Not guided
Note	The only non-mainland originator in the count

11. MK-2010 (LM-299)

Originator	LaNova Medicines (China)
Licensee and territory	Merck & Co: global. US$588 million upfront, up to US$2.7 billion in milestones (November 2024)
Most advanced trial	Phase 1/2 in China in PD-L1-positive NSCLC; Phase 2 MK-2010-002 (NCT07793942) registered with a planned start of 27 October 2026, and a combination study with sacituzumab tirumotecan (NCT07785609)
Comparator	None; the new Phase 2 tests MK-2010 alone and with pembrolizumab, chemo or belzutifan
Next readout	Not guided; no Phase 3 disclosed
Note	Merck owns Keytruda, so its plan pairs MK-2010 with pembrolizumab rather than testing against it

12. CVL006

Originator	Convalife (Shanghai)
Licensee and territory	None disclosed
Most advanced trial	Phase 1/2 combination study (NCT07157956); Phase 1 NCT06621615
Comparator	None
Next readout	Not guided
Note	PD-L1 single-domain (VHH) arm fused to an anti-VEGF IgG1

13. HLX37

Originator	Shanghai Henlius Biotech (China)
Licensee and territory	None disclosed
Most advanced trial	Phase 1 in solid tumours (NCT07274813); NMPA cleared a further study alone or with chemotherapy or Henlius's ADC HLX43 (July 2026)
Comparator	None
Next readout	Not guided
Note	The newest entrant in the count

What the count tells us

Pembrolizumab is the yardstick, but not everyone's. Five molecules are in, or have completed, a Phase 3 head-to-head against pembrolizumab, across nine trials: three for ivonescimab, two each for tivunatamig and pumitamig, and one each for SCTB14 and HB0025. Running against the world's best-selling cancer drug is the most expensive way to prove a point, and the most persuasive one for Western payers. Inside China, though, the commercial comparator is often tislelizumab, which explains why HARMONi-6 and RemeGen's first Phase 3 picked it.

The rights map is now mostly Western. Of the six molecules at Phase 3 or beyond, four have ex-China rights with a Western company. Only SCTB14 and HB0025 remain wholly held by their originators, and both are fighting pembrolizumab, which makes them the obvious next names on a buyer's list. At the earlier end the picture flips: of the seven molecules at Phase 2 or below, only MK-2010 sits with a Western owner.

The licence that came back. IMM2510 is the class's one reversal. Instil's subsidiary returned the rights in January without giving a reason. It is a reminder that a licence is an option, not a verdict, and that buyers trimming portfolios will drop the follower asset before the leader.

PD-1 or PD-L1 is still an open question. Seven molecules block PD-1 and six block PD-L1. Only one PD-L1 molecule, pumitamig, has a global Phase 3, so the class's clinical answer on which arm matters will come largely from BioNTech and BMS, and not before 2028.

The next fight is combinations. Pfizer is pairing tivunatamig with its ADCs; Summit has collaborations with Pfizer, AstraZeneca and Daiichi Sankyo, GSK and others; Merck is testing MK-2010 with sacituzumab tirumotecan; Minghui and Henlius pair their bispecifics with in-house ADCs. The bispecific is increasingly being positioned as the immunotherapy backbone for the next generation of regimens, rather than a standalone challenger.

The calendar: dates to watch

25 October: HARMONi-GI1, ivonescimab vs durvalumab in biliary tract cancer, ESMO Presidential Symposium (LBA8). First full hazard ratios.
26 October: Tivunatamig updated Phase 2 NSCLC data with chemotherapy, ESMO poster 2660P.
27 October: Planned start of Merck's MK-2010-002 Phase 2.
14 November: FDA action date for ivonescimab plus chemotherapy in EGFR-mutant NSCLC after TKI.
Second half of 2026: HARMONi-3 squamous cohort PFS, the first global head-to-head against pembrolizumab plus chemotherapy; pumitamig China TNBC Phase 3.
First half of 2027: HARMONi-3 non-squamous PFS and an interim OS look in the squamous cohort.
2028 and 2029: ROSETTA Lung-01, then Lung-02 and Breast-01, for pumitamig.

What we left out, and why

Several programmes sit near the boundary. Kelun-Biotech's SKB118 is a PD-1 x VEGF bispecific licensed into Greater China from the US company Crescent Biopharma, so it is not APAC-originated. AI-081, now with US-based OncoC4, came through a merger and we could not verify an APAC origin. Sailong's KH003 appears in a published review but we found no registry entry. An investigator-led Phase 3 at Shanghai Pulmonary Hospital (ChiCTR2600124154) tests an unnamed PD-1 x VEGF bispecific, so it cannot be assigned. Trispecifics, including BeOne Medicines' option on Huahui Health's HH160, are excluded by design. Industry tallies of the class vary widely, from 14 clinical products in a 2025 broker count to more than 30 assets at all stages in a 2026 intelligence tally; our narrower method, requiring a registered trial and an APAC originator, yields 13.

Sources and method notes

Trial identifiers and designs: ClinicalTrials.gov, China CDE drug trial registry and ChiCTR records, cross-checked with company releases. Licence terms: Summit Therapeutics SEC filings and releases (December 2022, June 2024, Q2 2026 10-Q, September 2026 8-K); Pfizer releases (19 May and 24 July 2025, 28 September 2026); BioNTech 6-K filings and releases (November 2024, June 2025, January and June 2026); RemeGen HKEX announcements (12 January and 24 August 2026) and AbbVie release; Merck release and LaNova HKEX notice (November 2024); Instil Bio 8-K (August 2024) and January 2026 release. Clinical results: Akeso HKEX announcements and releases (HARMONi-2 WCLC 2026; HARMONi-6; HARMONi-GI1, August 2026); Junshi AACR 2026 release. ESMO programme details: Summit and Pfizer releases. All data as of 13 October 2026.

This tracker is a class census, not an investment view or a ranking of clinical merit. Cross-trial comparisons are unreliable and none is intended. Trial statuses change frequently; corrections to the BioPharma APAC desk are welcome and will be reflected in dated updates. The tracker will be refreshed annually.