Sino strikes USD7bn multi-asset oncology deal with Boehringer

InventisBio’s selective TYK2 inhibitor nomelcitinib (D-2570) has met both primary and secondary endpoints in a Phase III study in moderate-to-severe plaque psoriasis.

The multicentre, randomised, double-blind, placebo-controlled study was designed to confirm the efficacy and safety of nomelcitinib enrolled a total of 391 patients assigned in a 1:1:1 ratio to two nomelcitinib treatment groups or a placebo group. 

At week 16, 70% of patients hit the primary endpoint of achieving at least a 90% improvement from baseline in PASI (Psoriasis Area Severity Index) score (PASI 90).

Sino Biopharmaceuticals has received breakthrough designation from China NMPA for TQ-A3334 and TQA3605 for the treatment of chronic hepatitis B.

TQ-A3334 is an orally administered, TLR7 agonist, which induces interferon and cytokine responses, according to the company, and complements the direct antiviral actions of nucleoside and nucleotide analogues (currently used to treat HBV).

TQA3605 is an allosteric modulator targeting the HBV core antigen (HbcAg), and is designed to block viral nucleocapsid formation inhibiting viral replication. Sino believes this mechanism would effectively inhibit HBV replication across multiple genotypes.

Both assets received breakthrough designation on the back of positive Phase 2 data.

Junshi (TopAlliance) has started a Phase 3 study combining two assets, JS207 and JS007, in the first-line treatment of advanced hepatocellular carcinoma. JS207 is an anti-PD-1/VEGF bispecific; JS007 is an anti-CTLA-4 monospecific.

The study, JS207-017-III-HCC, is a multi-centre, randomised, controlled, open-label designed to evaluate the safety and efficacy of the combination therapy compared to toripalimab (an anti-PD-1 injection and another Junshi asset) in combination with bevacizumab (Avastin). The study plans to enrol 560 patients, with the primary endpoints of progression free survival, and overall survival.

In their partnership announced in April 2026, Adagene and Incyte have dosed the first patient in a Phase 1 study combining muzastotug (Adagene’s masked, anti-CTLA-4 SAFEbody) with INCA33890 (Incyte’s TGFRbetaR2 / PD-1 bispecific) to treat microsatellite stable colorectal cancer (MSS CRC).

The study is is an open-label, dose escalation and expansion trial in third-line MSS CRC patients with and without liver metastases, with disease progression following prior therapies.

Alphamab has dosed its first patient in a Phase 3 study of JSKN033 to treat cervical cancer patients who have failed platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy.

JSKN033 is a combination therapy of JSKN003 (a bispecfic ADC targeting two HER2 epitopes) with Envafolimab (anti-PD-L1 nanbody).

The Phase 3 is an open-label, randomized, controlled, multicentre study designed to assess the efficacy and safety of JSKN033 versus physician choice chemotherapy. The primary endpoints are progression-free survival (PFS) and overall survival (OS).

Junshi has had a supplemental new drug application for toripalimab, in combination with disitamab vedotin, for the treatment of HER-2 expressing locally advanced or metastatic urothelial carcinoma, accepted by the China NMPA; the first step in the process towards marketing approval.

Toripalimab, an anti-PD-1 injection, is now in the approval process for 13 cancer indications in China.

China’s NMPA has approved GenSci’s IND to enter clinical studies for GenSci136 to treat Sjogren’s syndrome.

GenSci 136 is a dual antagonist fusion protein targeting B-cell activating factor (BAFF, also known as BLyS) and a proliferation-inducing ligand (APRIL), cytokines in the progression of autoimmune diseases.

The company proposes that blocking BAFF and APRIL has the potential to inhibit the survival and function of dysregulated B cells and antibody-secreting cells, thereby mitigating tissue and organ damage associated with the disease. Preclinical studies show good in vivo pharmacological activity with a prolonged duration of action and an acceptable safety profile, supporting further clinical development.

Hansoh has released primary data from its Phase 3 ARTEMIS-011 study of risvetatug rezetecan (Ris-Rez - a B7-H3 targeting ADC) versus gemcitabine plus docetaxel (GD) in patients with relapsed of refractory osteosarcoma, following failure with at least two prior lines of therapy.

Median PFS (the study primary endpoint) of Ris-Rez was 5.5 months vs 1.4 months on GD (p<0.0001), a 67% reduction in disease progression or death.

Kelun Biotech announced the overall survival (OS) data from its Phase 3 OptiTROP-Breast01 study of sacituzumab tirumotecan (sac-TMT) vs chemotherapy in patients with locally recurrent or metastatic triple-negative breast cancer.

At 30 months, the OS rate was 26.8% in the sac-TMT group, versus 13.2% for patients on chemotherapy, a 40% reduction in the risk of death. The data is published in the Annals of Oncology.  

Based on earlier data, sac-TMT received NMPA approval in China in November 2024 for the patient group who had failed at least two prior therapy regimens.

Separately, an IND for sac-TMT in combination with pemrolizumab has been accepted for review at China's NMPA for the first-line treatment of PD-L1-negative non-squamour NSCLC.

Junshi (Top Alliance) has dosed the first patient in its randomised, open-label, multicentre, Phase 3 study of JS203 (an anti-CD20/CD3 bispecific) in combination with chemotherapy, versus rituximab in combination with chemotherapy, to treat relapsed/refractory diffuse large B-cell lymphoma. The study aims to enrol 282 patients, with overall survival as the primary endpoint.

Presentating at the ESMO conference, Hansoh released data on a Phase 3 study of dalmelitinib, its oral c-MET tyrosine kinase inhibitor (TKI) in combination with Aumolertinib (an EGFR-TKI) to treat locally advanced or metastatic non-small cell lung cancer (NSCLC).

The data showed statistically significant, and clinically meaningful, improvement in progression free survival, with median PFS at 6.2 months vs 4.4 months in the arm receiving chemotherapy.

The HS-10241-301 study, was a randomised, open label, Phase 3 enrolling 314 NSCLC patients harbouring EGFR mutations, MET amplification, and had progressed following EGFR-TKI therapy alone.

HUTCHMED has released positive Phase 3 data from its SANOVO study in China, combining its Orphathys (savolitinib) with marketed Tagrisso (osimertinib) in treatment-naïve patients with epidermal growth factor receptor-mutated (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC) and MET overexpression. 

The combination therapy demonstrated statistically relevant median PFS of 24.9 months versus 13.8 months and a reduction of disease progression and death by 44%, over patients on Tagrisso alone. In the higher MET population, median PFS was 24.8 months versus 11.1 months and a reduction of disease progression and death of 55%.

The second SAFFRON study, in the same indication, compared combination therapy against chemotherapy. Here the risk for progression and death was reduced by 45% with a median PFS of 7.6 months versus 5.4 months. The results are published in the New England Journal of Medicine.

At the ASN Kidney Week conference, Hansoh presented data on its Phase 3 study of gosicalcetide in patients with chronic kidney disease (CKD) receiving haemodialysis complicate by secondary hyperparathyroidism.

The Phase 3 study compared goscalcetide (an intravenous calcimimetic that inhibits parathyroid hormone(PTH)) with cinacalcet (the existing first-line therapy for the indication), and showed a significant proportion of patients had a >30% and >50% reduction from baseline of intact PTH.

In an interim analysis of its HARMONi-GI1 study, Akeso showed that Ivonescimab with chemotherapy significantly improved overall survival versus durvalumab (PD-L1) with chemotherapy.

Ivonescimab (a PD-1/VEGF bispecific), demonstrated media OS 14.9 months versus 12.1 months for patients on druvalumab plus chemo (the current first-line therapy for the indication), and PFS of 8.4 months versus 5.8 months.

Antengene presented to the ESMO conference Phase 2 data from its study of ATG-022, its Claudin 18.2 targeting ADC in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma.

The data covered 30 patients in the 1.8 mg/kg cohort and showed an ORR of 46.7%, a DCR of 86.7%, and a mPFS of 5.6 months.

Harbour BioMed has received China NMPA marketing approval for Batoclimab to treat generalised myasthenia gravis (gMG),  a rare, chronic, autoimmune neuromuscular disorder.

Approval of the BLA comes on the back of Harbour’s Phase 3 study in 27 centres across China, which showed that 58.2% of patients on therapy had improved and sustained outcomes over 31.3% in the placebo group (p=0.001).

Batoclimab is a fully human monoclonal antibody targeting the neonatal Fc receptor (FcRn). Harbour proposes that by blocking FcRn-mediated recycling of IgG antibodies, batoclimab accelerates the degradation of pathogenic IgG autoantibodies, offering a targeted therapeutic approach for autoimmune conditions including gMG. 

The product is licenced to CSPC Pharmaceuticals in China.

CSPC has initiated two separate clinical programmes in China.

The first is a Phase 3 study of SYS6043, a B7-H3 ADC, for first-line treatment of unresectable recurrent or metastatic triple-negative breast cancer. The company proposes that SYS6043 binds to cells expressing B7-H3, and is internalised releasing a small-molecule toxin to kill tumour cells. The trial is a randomised open-label, multi-centre Phase III clinical trial, aiming to evaluate the clinical efficacy and safety of the product as the first-line treatment, compared to the investigator’s choice of chemotherapy.

The second study is a Phase 2 for SYH2066, a small molecule RSV fusion protein inhibitor for the treatment of respiratory syncytial virus infection. The proposed mechanism for SYH2066 is that it binds to and locks the F protein of RSV, it prevents membrane fusion between virus and host cell, preventing the replication cycle.

The clinical trial initiated is a multi-centre, randomised, double-blind, placebo-controlled Phase II clinical trial, aiming to evaluate the efficacy and safety of the Product in Chinese adult participants with RSV infection.

Doer Biologics has received two China NMPA IND approvals for DR30206, its antibody fusion protein targeting PD-L1, VEGF, and TGF-β. 

The first IND is for locally advanced, unresectable stage 3 non-small cell lung cancer where disease has not progressed after chemoradiotherapy. The second IND is for patients with recurrent or metastatic head and neck squamous cell carcinoma, in combination with chemotherapy.

Doer proposes that DR30206 reinvigorates exhausted CD8⁺ T cells by blocking the PD-1/PD-L1 signaling pathway; plus, by specifically binding free VEGF and TGF-β, can reduces tumour angiogenesis, relieve immunosuppression, and thereby exert antitumour activity. 

Leads Biolabs has expanded its Phase 2 study of Opamtistomig into first-line gastric cancer, the asset's fifth gastro-intestinal cancer indication.

This expansion is investigate Opamtistomig, a PD-L1/4-BB bispecific antibody, in combination with chemotherapy, in locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

Opamtistomig activates 4-1BB while blocking PD-1/PD-L1, reactivating and expanding T cells. The company proposes that as T cell expansion is not dependent on high PD-L1 expression, the product may have efficacy in patients where checkpoint monotherapy fails.

The other Phase 2 indications are biliary tract cancer, hepatocellular carcinoma, esophageal squamous cell carcinoma, and colorectal cancer.

Hengrui has published in the Journal of Clinical Oncology (1) the results from its Phase 3 study of Retlirafusp alpha, in combination with chemotherapy, as a first line treatment of unresectable, locally advanced or metastatic, HER2–negative gastric or gastroesophageal junction adenocarcinoma.

In this randomized, double-blind (RELIGHT) study, 731 patients received retlirafusp or placebo in combination with capecitabine and oxaliplatin (CAPOX).

Retlirafusp and CAPOX significantly prolonged overall survival (OS), (p<0.0001) the primary endpoint.

1: https://ascopubs.org/doi/abs/10.1200/JCO-25-02933

METiS TechBio has signed a deal with Eli Lilly to research and develop tissue-specific drug delivery technologies. The deal was valued at USD1.1bn, in upfront payments and milestones, plus royalties.

METiS will use its AI-powered ionisable lipid discovery and optimisation platform to develop new lipid nanoparticles (LNP) designed to improve targeting and biodistribution of LNP-based drugs.

Hansoh Pharmaceutical has entered a collaboration and licensing deal with Roche to develop novel ADCs globally; the deal includes two preclinical assets from Hansoh, plus multiple further programmes based on Roche targets.

Hansoh will receive an upfront payment of USD400m plus a first anniversary payment of USD110m, and is eligible for over USD15bn in development, regulatory, and commercial milestones, and further royalties on sales.

Under the deal, Hansoh will lead the early asset development, up to completion of global Phase 1 studies. Roche will then be responsible for further development globally, outside of China, Macau, Hong Kong, and Taiwan, where Hansoh maintains rights.

The deal is an expansion of an earlier collaboration between the two companies, announced in October 2025.

Brii Biosciences has launched BRiSC (Bispecific RNAi SilenCing), its proprietary siRNA drug discovery platform.

BriSC combines sequence optimisation, chemical modification, targeted delivery, and dual-targeting architecture technologies.

The latter enables a single siRNA to simultaneously silence two distinct targets, which the company proposes, could address diseases with multiple pathways through a single treatment.

Sinovac, with the Institute of Biophysics (part of the Chinese Academy of Sciences), has received China NMPA clearance to start clinical development of SNA01 to prevent RSV-associated respiratory tract infections in newborns and infants up to 24 months old.

SNA01 injection is a recombinant, fully human IgG1κ monoclonal antibody designed to target the RSV fusion protein, neutralize the virus and provide passive immunity. With the Fc region engineered to extend half-life, the asset has the potential to provide protection throughout an RSV season with a single intramuscular injection.

Insilico advances with ISM9546, its preclinical asset addressing autoimmune diseases. ISM9546, a molecular glue degrader, was engineered through AI-powered, in silico iteration, and targets VAV1 (Vav guanine nucleotide exchange factor 1), involved in immune signalling pathways. The company proposes ISM9546 has the potential to address autoimmune diseases through the control of cell activation and proliferation, cytoskeletal dynamics, and cytokine secretion.

Historically, VAV1 was considered undruggable, however Insilico has shown preclinical efficacy in animal models of IBD, alongside encouraging safety and pharmokinetic profiles, with low CNS and brain exposure.

Hengrui received EMA marketing authorisation for Wevdury fuzuloparib, in combination with abiraterone acetate and prednisone or prednisolone, for metastatic castration-resistant prostate cancer.

Fuzuloparib, an orally available small molecule PARP inhibitor, showed efficacy in an international, 496 patient, Phase 3 study, with progression-free survival at 24.8 months, versus 19.9 months in the control arm.

Fuzuloparib was first approved in China in 2020, and now has China approval in five cancer indications.

Hengrui has approval from China’s NMPA to start clinical development of SHR-3201 injection to treat Alzheimer’s disease

Hiteck Biological Pharma has granted NovaBridge an exclusive global licence, outside of Greater China, to HT006.2.2, a recombinant human nerve growth factor (rhNGF) in development for the treatment of neurotrophic keratitis (NK).

Hiteck will receive an undisclosed upfront payment; development, regulatory, and commercial milestones, plus tiered royalties.

In a Phase 1b study of HT006.2.2, 50% of patients showed complete corneal healing in the highest dose cohort after 8 weeks, compared with 14% in the control group.

ArkBio has received US FDA clearance to start its Phase 2 study of AK0406, a long-acting antiviral drug-Fc conjugate for the prevention of influenza.

The Phase 2 will be a multicentre, randomised, double-blind, placebo-controlled study in adults over the influenza season. The primary objective is influenza prevention, but also to assess safety, tolerability, PK, and immunogenicity.

Going forward ArkBio is in discussions with the FDA and China’s NMPA around parallel development pathways that could accelerate with programme, address challenges around viral evolution, and support high-risk populations.

AK0506 comprises multiple small molecule antivirals conjugated to an antibody Fc domain, which the company proposes offers both direct antiviral activity alongside Fc-mediated immune clearance to prevent influenza.

Rona Therapeutics has signed up with Roche around its ALK7-targeting RNAi asset to treat obesity and metabolic diseases.

Rona will receive and upfront and near-term payments of up to USD100m, and is eligible to a further USD1.06bn in development, regulatory, and commercial milestones, plus royalties. In return, Roche has gain exclusive worldwide rights to the programme.

ALK7 is predominantly expressed in adipose tissue, and the partners propose that its inhibition has the potential to reduce visceral and other ectopic fat deposits, while maintaining lean muscle mass.

Doer Biologics has received approval from China’s NMPA for clinical development of DR30206, in combination with chemotherapy, for the treatment of head and neck squamous cell carcinoma.

The DR30206 injection is an antibody fusion protein targeting PD-L1, VEGF, and TGF-beta designed to restore the proliferation of CD8+ T cells, and reduce tumour neovascularisation. Non-clinical and Phase 1 studies have shown evidence of the DR30206 mechanism of action, with inhibition of tumour growth, and a favourable safety profile in patients with lung cancer.

According to Doer, there are currently no approved antibody fusion proteins simultaneously hitting these three targets.

InnoCare Pharma has received approval from China’s NMPA for a Phase 3 study of Mesutoclax (ICP-248), in combination with orelabrutinib, for the treatment of marginal zone lymphoma (MZL) who have received at least one prior therapy.

Mesutoclax is an oral BCL2 inhibitor designed to restore normal apoptosis mechanisms in cancer cells, and is now in five ongoing clinical studies in cancer.

T-MAXIMUM has received US FDA clearance for a Phase 2 study of MT027 for the treatment of brain metastases from lung and breast cancer primary tumours.

MT027 is B7-H3 targeted allogeneic CAR-T therapy constructed using a non-viral gene-editing process.

InnoCare has received China NMPA approval for its IND application of ICP-B161, a bispecific targeting TL1A and IL-24p19 for the treatment of autoimmune diseases, including inflammatory bowel disease (IBD).

In preclinical studies, InnoCare has shown synergistic effects from the dual targeting mechanism to suppress cytokine release and mitigate inflammatory responses. In animal models, ICP-B161 exhibited dose-dependent responses, and significantly inhibited colitis-related symptoms.

ICP-B161 is InnoCare’s fifth asset to enter the clinic in 2026.

Over the weekend, Akeso announced the dosing of the first patient in its Phase 3 COMPASSION study of Cadonilimab as a monotherapy in perioperative treatment ofresectable microsatellite instability-high or mismatch repair-deficient colon cancer.

Cadonilimab has multiple marketing approvals from China’s NMPA, intiially (in 2022) to treat patients with relapsed or metastatic cervical cancer with disease progression following platinum-based chemotherapy; but in 2025 approved as first line therapy in combination with chemotherapy for the same indication. The drug also has approval as first-line treatment in combination with chemotherapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma (since 2024).

Cadonilimab is a bispecific antibody targeting PD-1 and CTLA-4, which Akeso has shown to have robust efficacy, improved tolerability and lower toxicity compared to current combination regimens. The asset has been in 40 studies spanning 20 indications, including multiple cancers; and is currently in 13 Phase 3 studies, three of which have met primary endpoints, with 2 more in advanced stages.

Innovent's Phase 3 study of SYCUME (Teprotumumab) to treat Inactive Thyroid Eye Disease (TED), met its primary endpoint, significantly improving proptosis (abnormal eye protrusions and bulging), with a favourable safety profile. RESTORE-3 was a multicentre, randomised, double-blind, placebo-controlled study of SYCUME injectable in 116 patients.

SYCUME is a recombinant antibody targeting anti-insulin-like growth factor 1 receptor (IGF-1R); IGF-1R is a transmembrane tyrosine kinase receptor involved in development, metabolism, and immune regulation, and is overexpressed in Orbital Fibroblasts (OFs), B cells, and T cells of TED patients.

SYCUME received China NMPA approval in 2025, and listed on the China National Reimburesement Drug List at the start of 2026.

ApicHope subsidiary, Yipinhong Pharmaceutical, has received US FDA approval for clinical studies of APH04935, its GLP-1 targeting oral, small molecule for weight control and weight loss. The asset received China NMPA approval for clinical studies in August this year. The company is seeking to develop APH04935 as a daily tablet.

Ribo Life Science and subsidiary Ribocure, have received approval for a European Phase 1 study of RBD3133 to treat obesity and excess weight.

The randomised, placebo-controlled study is designed to assess safety, tolerability, pharmacokinetics, and pharmcodynamics of subcutaneously administered RBD3133 in individuals with obesity or excess weight.

RBD3133 is an siRNA, next generation therapeutic, designed to selectively silence INHBE (inhibin subunit beta E), a gene encoding Activin E central in regulating energy homeostasis, fat distribution, and lipolysis in adipose tissue.

Asieris has granted Theramex exclusive rights to CEVIRA in Europe, Australia, New Zealand, and Turkey for USD26m in upfront and milestone payments. Including future royalties, the companies estimate the deal to be valued at over USD250m.

CERIVA (APL-1702) is a photodynamic drug-device in development as a non-surgical treatment for cervical precancerous lesions associated with HPV, including cervical intra-epithelial neoplasia. Asieris notes that
CERIVA is a non-surgical approach designed to preserve cervical tissues.

CERIVA received China NMPA approval for the indication in March 2026.

AnnJi Pharmaceutical has received US FDA approval to proceed with the US arm of its pivotal Phase 3 study of AJ201 (rosolutamide) to treat spinal and bulbar muscular atrophy (SBMA or Kennedy’s disease). AJ201 has both US and EU orphan drug designation.

The ROMA-KD Phase 3 is a global, multi-centre, randomised, double-blind, placebo-controlled study, to evaluate the efficacy and safety of AJ201 in around 200 ambulatory individuals with SBMA.

AJ201 is an oral, small molecule that promotes the clearance of pathogenic mutant androgen receptor (mAR) protein by activating cellular stress-response pathways such as Nrf1, Nrf2, and HSF1.

SBMA is a rare, X-linked inherited neuromuscular disorder caused by a trinucleotide CAG repeat expansion of the androgen receptor gene, resulting in motor neuron and muscular degeneration. AnnJi proposes that SBMA is likely under-diagnosed, as symptoms are similar to other neuromuscular conditions, such as ALS, and with no currently approved drug for SBMA, genetic testing for the disease is not routine.

Abogen Biosciences has signed a deal with Novartis which kicks off with a USD575m upfront payment, stretching to USD7.2bn in regulatory and commercial milestones; plus royalties on sales.

The deal revolves around ABO2203, Abogen’s mRNA-encoded CD19/CD3 T-cell engager to treat autoimmune diseases. The company proposes that ABO2203 can reset B cells and direct the endogenous production of T-cell engagers in vivo, addressing the issues of B cell depletion seen with current approaches.

Novartis has secured a global license to the asset, and exclusive options to other Abogen programmes.

Phrontline has entered the clinic for the first time, in a Phase 1/2 study of TJ102 – an FRalpha / CDH6 bispecific ADC linked to a topoisomerase 1 inhibitor and a microtubule inhibitor – to treat advanced or metastatic breast cancer and other solid tumours. The open-label study will assess  safety, tolerability, pharmacokinetics, immunogenicity and preliminary antitumor activity, with dose escalation followed by dose-optimization and expansion cohorts to select recommended dose(s) for further development.

In its global commercialisation deal of Zegfrovy sunvozertinib with AstraZeneca, Dizal has received its upfront payment of USD600m. Zegfrovy, an EGFR inhibitor, is approved in China and the US to treat locally advanced or metastatic non-small cell lung cancer in patients with tumours carrying exon 20 insertion mutations, where disease progressed following platinum-based chemo. Dizal is eligible for up to a further USD900m in development, regulatory, and sales milestone; plus royalties on sales.

HUTCHMED and AstraZeneca have submitted an NDA with the US FDA for ORPATHYS (savolitinib) plus TAGRISSO (osimertinib) to treat locally advanced or metastatic non-small cell lung cancer (NSCLC), where tumours have MET overexpression, a failed epidermal growth factor recepetor (EGFR) and tyrosine kinase inhibitor (TKI) therapy.

The NDA is backed up with the SAFFRON Phase 3 study data, which showed ORPATHYS plus TAGRISSO showed a statistically significant and clinically meaningful improvement in progression free survival and overall survival.

Johnny Cheng, acting CEO and CFO of HUTCHMED noted that the filing is an important step in bringing this combination therapy to US patients, following its approval in China in June 2025.

Hengrui Pharma and Novo Nordisk have agreed an exclusive deal which the parties are valuing at up to USD2.6bn; comprising development, regulatory, and commercial milestones, but kicks off with a USD300m upfront payment; plus Hengrui is eligible for royalties.

The deal revolves around HRS-1596, Hengrui’s GLP-1R and GIPR dual agonist, with the potential for once-weekly oral dosing. Novo now has exclusive rights to develop, manufacture, and commercialise the asset globally outside of China, Hong Kong, Macao, and Taiwan.

Hengrui describes the asset as “Phase 1 ready”, and has NMPA approval to start Phase 1 development in China.

Innovent Biologics and partner Takeda Pharmaceuticals have received US FDA approval to expand its Phase 3 study (MarsLight-11) of IBI363/TAK-928 to include non-squamous non-small cell lung cancer (NSCLC) patients. Previously the study only included squamous NSCLC. The global, multicentre, randomised, Phase 3 is assessing efficacy and safety of IBI363 monotherapy vs docetaxel in patients with unresectable or metastatic NSCLC whose disease progressed under platinum-based chemo and anti-PD-1/PD-L1 therapy. IBI363 is an alpha-biased IL-2/PD-1 bispecific protein is a PD-1/PD-L1 antagonist and IL-2 agonist.

At the International Myeloma Society meeting over the weekend in Glasgow, Scotland, UK IASO released its first data on two assets to treat relapsed / refractory multiple myeloma. A group of 10 patients, receiving a single infusion of IASO206 (a BCMA-targeted CAR-T cell therapy), showed a robust expansion of CAR-positive T cells, with peak between 12 and 21 days, but detectable up to six months after treatment. IASO206, administered without apheresis or lymphodepleting chemo, achieved a 90% objective response rate, increasing to 100% in the higher dose cohort. In a second data release in 9 patients, IASO announced RD140, a fully human BCMA/GPRC5D dual-targeted FasT CAR-T cell therapy, showed an 88.9% objective response rate, again hitting 100% in the higher dose cohort. RD140 was built on the FasT CAR-T platform, with cell manufacturing in 3-4 days.

InnoCare Pharma has signed a research collaboration and license agreement with Eli Lilly. InnoCare will leverage its drug discovery platform to discover and develop drug assets against up to five undisclosed targets. Lilly will pay up to USD100m in upfront and near-term payments, and up to USD3.25bn in development and commercialisation milestones, plus single-digit royalties on sales. InnoCare is focused on the development of innovative drugs to treat cancer and autoimmune diseases, has three approved drugs, 10 assets in the clinic, and multiple preclinical programmes.

United Biotechnology has received a USD9m milestone payment from Novo Nordisk in its global Phase 2 trial of UBT251 to treat obesity, type 2 diabetes, and other diseases. UBT251 is a long-acting, injectable, triple agonist of GLP-1, GIP, and GCG. Under the agreement with Novo, UBT is eligible to receive up to USD1.8bn in milestones, plus tiered royalties on sales.

Hansoh Pharma announced that HS-10374, allosteric inhibitor of tyrosine kinase (TYK2), met its primary endpoints in its pivotal Phase 3 study to treat moderate-to-severe psoriasis in adults. At 16 weeks patients showed a statistically significant improvement over placebo with both the PASI (Posriasis Area and Severity Index) and sPGA (static Physician’s Global Assessment) endpoints. Statistical significance in PASI is considered a 75% reduction over baseline (PASI 75); more than half of patients on HS-10374 achieved PASI 90, and one third PASI 100 at week 16. Based on these data Hansoh will advance its communications with China’s NMPA to seek regulatory approval.

Hengrui has recevied regulatory approval for three clinical programmes. Firstly, for HRS-4729 polypeptide injectable, triple GLP-1R, GIPR, and GCGR agonist for the treatment of chronic kidney disease. The company proposes that, weight loss, improved insulin resistance and reduction in ectopic fat, would reduce metabolic burden on the kidneys. Secondly, SHR-4595 is an injectable to treat advanced malignant solid tumours by binding to known tumour-cell surface antigens. Finally, HRS-1596 tablets for weight management and type 2 diabetes. The asset showed weight loss and improved blood glucose indicators in animal models of obesity and diabetes. The company believes this to be the first orally available asset to be hitting this known (but undisclosed) target.

BioKin (Baili Tianheng) clinical progress has triggered the next USD250m milestone payment in its collaboration with BMS. The deal revolves around Izabren (Lencon Ilonutumab; BL-B01D1) in oncology. The asset has reached an undisclosed milestone in the IZABRIGHT-Lung02 global Phase 3 study. BioKen is eligible to up to USD7.1bn in future payments contingent on development, registration, and sales milestones.

BoomRay Pharmaceuticals has entered an exclusive global licensing deal with Novartis for an undisclosed pre-clinical radioligand therapy (RLT) asset for oncology applications. Under the agreement, BoomRay is eligible to receive up to USD900m in upfront, development, regulatory and sales milestone payments; plus potential royalties on global sales. BoomRay has a pipeline of clinical and preclinical RLT programmes, which combine a radio-isotope with a tumour binding ligand. The company proposes that the RLT mechanism of action is less susceptible to drug resistance, as the cytotoxic effect is not dependent on cellular uptake or active transport pathways.

Accro Bio has dosed its first patient in a Phase 2b study of AC-101 (a selective RIPK2 inhibitor) to treat moderate-to-severe ulcerative colitis. The study is a multi-centre, double-blind, trial with two AC-101 cohorts against one placebo-controlled. The primary endpoint is clinical remission at week 12; with exploratory endpoints of histological remission, and maintenance of histological and clinical remission over long-term treatment.

CSPC has started patient recruitment into its Phase 2 study of SYH2069 injection to treat Type-2 diabetes mellitus. SYH2069 is a fatty acid-modified polypeptide, and dual agonist of GLP-1R and GIPR. The product is designed to promote insulin secretion, but also expected to suppress appetite, delay gastric emptying, increase satiation relating to weight-loss effects.

The US FDA has cleared the IND for IASO208 CD20-targeting CAR-T therapy. IASO208 uses a lentivial vector to deliver humanised anti-CD20 CAR transgene, to generate anti-CD20 CAR-T cells. IASO208 is currently in a Phase 1 study in China to assess safety, tolerability, and early efficacy in patients with relapsed/refractory B-cell malignancies.

GSK has acquired the global rights to Chimagen’s trispecfic T cell-engager to treat multiple myeloma for up to USD750m in upfront, development and commercial milestone payments. The asset is engineered to bind to T cells plus two strategically selected tumour-associated antigens. GSK plans to take the product in the Phase 1 trials in 2027.

Results from Kelun’s Phase 3 study of trastuzumab botidotin to treat HER-2 positive unresectable or metastatic breast cancer are now published in the Journal of Clinical Oncology (JCO). The study showed that trastuzumab botidotin monotherapy significantly prolonged progression free survival over trastuzumab emtansine.

Tambotatug Pelitecan (Tam-Peli), an anti-B7-H3 ADC from MediLink, met its primary endpoint of overall survival, and demonstrated a 54% reduction in the risk of death. Tam-Peli also significantly extended progression free survival. The new data was generated in a P3 study of Tam-Peli vs Topotecan chemotherapy, in small cell lung cancer patients that had disease progression following platinum-based chemo. The trial enrolled 451 patients across 85 sites in China. Roche has exclusive commercialisation rights to Tam-Peli outside of China, Hong Kong, and Macau.

CMS was granted Drug Clinical Trial Approval Notice from China’s NMPA for CMS-D001 to treat systemic lupus erthematosus. CMS-D001 is an oral inhibitor of TYK2, and member of the JAK family. CMS proposes that, compared to pan-JAK inbibitors, CMS-D001 is more selective and has the potential to reduce side effects and without risk of anti-drug antibody formation

OcuMension’s NCX 470 (OT-301), to lower intraocular pressure in patients with open-angel glaucoma or ocular hypertensions, has its NDA accepted for review by the NMPA. OcuMension has commercialisation rights to the product – from Nicox – in China, Korea, and South East Asia.

Adagene’s partner Third Arc Bio has selected its first antibody drug development candidate from Adagene’s SAFEbody platform. Under an agreement from November 2025, Adagene is providing Masked CD3 T cell antibodies targeting epitopes of tumour-associated antigens.

TenNor’s topline results from its Phase 2a rifaquizinone (TNP-2092) provided proof-of-concept of the product’s potential to treat Periprosthetic Joint Infection (PJI) without surgical intervention. Rifaquizinone is a first-in-class, triple-targeting anti-infective addressing implant-associated biofilm infections.

Harbour BioMed added to Stock Connect on the Hong Kong exchange. The company has a market cap exceeding HK$10bn (USD1.27bn)

Adagene received a USD$2m preclinical milestone payment from Exelixis for XB404, built with Adagene’s SAFEbody masking technology, and designed to deliver a cytotoxic payload to tumours expressing ROR1/2.

Transcenta granted WuXi a non-exclusive license to its bioprocessing platform and cell culture media for RMB10m (USD1.5m). Transcenta has a pipeline of clinical and preclinical stage oncology products, plus products in osteoporosis and other auto-immune diseases

Harbour’s parner Windward Bio has reported positive P2 results with HBM9378/WIN378 the companies’ joint product in asthma, triggering the start of a P3 study. The product is also has potential in other respiratory immunological conditions.

InnoCare received NMPA (China’s National Medical Products Administration) approval of its IND for ICP-B382, bispecific ADC targeting PSMA and STEAP1 for the treatment of solid tumours including prostate cancer. This is InnoCare’s first bispecific ADC to enter clinical studies. ICP-B381 is targeting PSMA and STEAP1 as they are significantly overexpressed in prostate cancer cells with limited expression in normal tissue, making them highly promising therapeutic targets. 

Interim data from Akeso’s Phase 3 HARMONi-2 study of ivonescimab PD-1/VEGF bispecific antibody demonstrated a statistically significant and clinically meaningful improvement over Pembrolizumab in non-small cell lung cancer with tumours expressing PD-L1.

CStone Pharmaceuticals now included in the Hong Kong exchange. CStone focuses on drug development across oncology, immunology and inflammation.

Hansoh Pharma says the China National Medical Products Administration (NMPA）has accepted its biologics license application (BLA) for HS-20093（Risvutatug rezetecan, or Ris-Rez）injectable to treat small cell lung cancer (SCLC). Ris-Rez is a B7-H3-targeted antibody-drug conjugate (ADC) under clinical development for multiple solid tumors. The BLA is supported by results from a pivotal Phase 3 clinical trial (ARTEMIS-008) for patients with advanced or relapsed SCLC after prior platinum-based therapy.

HUTCHMED and GSK signed an exclusive global licensing agreement covering a portfolio of cancer therapies targeting KRAS mutations and EGFR.