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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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. 

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.

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.

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.

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.

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.

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.

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

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.

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

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

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.

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