This week’s biotech updates include Zelgen resubmitting its Hong Kong IPO after turning profitable, Innovent partnering with Daiichi Sankyo to commercialize Vanflyta in China, Gan & Lee signing a EUR 726M deal with Menarini for Bofanglutide, and IASO Bio acquiring MediSix to enhance cell therapy capabilities.

Transactions & BD (In/Out Licensing)

Zelgen (688266.SH) Resubmits Hong Kong IPO Application After Turning Profitable in H1 2026

Key Words: Zelgen Biopharmaceuticals, Hong Kong IPO, A+H Listing, ZG006, AbbVie, ZG005, Commercialization

• The News: Zelgen Biopharmaceuticals has resubmitted its application for listing on the Hong Kong Stock Exchange, aiming to establish a dual A+H listing structure. This follows the lapse of its previous application in June 2026. The company also marked a major milestone, reporting its first half-year profit since its initial public offering on the STAR Market in 2020.
• Key Highlights:
• Deal Details:
  • Listing Structure: Zelgen is pursuing an H-share offering while retaining its STAR Market listing, potentially forming a dual A+H listing structure.
  • Application Status: The filing is currently under HKEX review.
  • Revenue: H1 2026 revenue reached approximately RMB 1.21 billion, representing a 220.9% year-on-year increase.
  • Profitability: Net profit attributable to shareholders was RMB 640 million, compared with a RMB 72.8 million loss in the prior-year period.
  • Product Sales: Revenue from commercialized products totaled approximately RMB 550 million, a 44.3% year-on-year increase.
• Product Profile – ZG006:
  • ZG006: an investigational DLL3×DLL3×CD3 trispecific T-cell engager.
  • Mechanism: Two DLL3-binding domains recognize different epitopes on tumor cells, while the CD3-binding domain recruits T cells to induce tumor-cell killing.
  • Indication Focus: Designed for treating small-cell lung cancer and other DLL3-positive neuroendocrine malignancies.
  • Potential Differentiation: Its dual DLL3 binding and attenuated CD3 affinity are designed to improve tumor engagement while managing cytokine-release risk.
  • Development Stage: Late-stage clinical development, with CDE Breakthrough Therapy Designation and FDA Orphan Drug Designation.

 

Innovent Biologics (1801.HK) and Daiichi Sankyo (4568.T) Announce Exclusive Agreement for VANFLYTA® Commercialization in China

Key Words: Innovent Biologics, Daiichi Sankyo, Vanflyta, quizartinib, FLT3 inhibitor, acute myeloid leukemia, commercialization agreement

• The News: Innovent Biologics and Daiichi Sankyo announced an exclusive agreement for the commercialization of Vanflyta® (quizartinib) in China. This partnership aims to expand patient access to Vanflyta®, a recently approved therapy for FLT3-ITD positive acute myeloid leukemia (AML).
• Key Highlights:
• Key Details of the Agreement:
  • Daiichi Sankyo will oversee the development, manufacturing, and supply of Vanflyta®.
  • Innovent Biologics will hold sole commercialization rights in China, leading all market promotion activities.
• Vanflyta® (quizartinib), an oral and highly potent type II FLT3 inhibitor developed by Daiichi Sankyo, received approval in China in June 2026 for:
  • Combination with standard chemotherapy: Cytarabine and anthracycline induction followed by cytarabine consolidation.
  • Maintenance monotherapy: Used after consolidation chemotherapy.
• This approval is based on results from the Phase III QuANTUM-First trial, which demonstrated significant efficacy in adults with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML):
  • Mechanism of Action: Vanflyta selectively inhibits FLT3 signaling, particularly targeting the FLT3 internal tandem duplication (FLT3-ITD) mutation, a key driver of aggressive disease progression and poor prognosis in AML.
  • Trial Data: In a study of 539 patients, the quizartinib regimen improved median overall survival (OS) to 31.9 months compared to 15.1 months with placebo plus standard therapy, reducing the risk of death by 22% (HR=0.78; 95% CI: 0.62-0.98; p=0.032).

 

Gan & Lee Pharmaceuticals (603087.SH) Signs EUR 726 Million Out-Licensing Deal with Menarini for Twice-Monthly Bofanglutide Across 39 European Markets

Key Words: Gan & Lee Pharmaceuticals, Menarini, bofanglutide, GZR18, GLP-1 receptor agonist, obesity, licensing agreement, Europe

• The News: Gan & Lee Pharmaceuticals announced an out-licensing agreement with Menarini for Bofanglutide Injection (development code: GZR18), a novel once-every-two-weeks glucagon-like peptide-1 receptor agonist (GLP-1 RA). The agreement, worth up to EUR 726 million excluding royalties, grants Menarini rights to regulatory filing and commercialization of Bofanglutide across 39 European countries and regions.
• Key Highlights:
• The agreement outlines the following terms:
  • Total Deal Worth: Up to EUR 726 million (approximately US$ 843 million), including milestone payments.
  • Upfront Payment: US$ 72 million, non-refundable.
  • Milestone Payments: Up to US$ 771 million, tied to development, regulatory, and commercial achievements.
  • Territory: The partnership spans 39 countries and regions, including the EU’s 27 member states, the UK, Switzerland, Norway, Iceland, Liechtenstein, and the Balkan region.
• About Bofanglutide (GZR18):
  • Bofanglutide is a long-acting glucagon-like peptide-1 receptor agonist (GLP-1 RA) developed by Gan & Lee Pharmaceuticals. Its biweekly dosing offers a significant advantage over traditional weekly formulations by reducing injection frequency and improving treatment adherence.
  • Mechanism of Action: Bofanglutide delays gastric emptying, enhances satiety, and reduces food intake, supporting both weight management and glycemic control.
  • Indications: Approved for obesity, overweight, and other metabolic diseases.
  • Clinical Validation: Phase III pivotal trials conducted in China demonstrated significant efficacy. In the GRADUAL-1 trial involving 640 participants, Bofanglutide reduced mean body weight by 15.12% (24 mg) and 18.54% (48 mg) compared with 1.11% for placebo after 52 weeks.
• Menarini is Italy’s largest privately held pharmaceutical company, with a robust presence in 140 countries globally. The company’s portfolio spans cardiometabolic diseases, oncology, gastroenterology, diabetes, and respiratory medicine, making it an ideal partner for expanding Bofanglutide’s reach across Europe.

BeOne Medicines (6160.HK; ONC.O; 688235.SS) and Revolution Medicines (RVMD.O) Form Strategic RAS(ON) Collaboration in Asia

Key Words: BeOne Medicines, Revolution Medicines, RAS(ON) inhibitors, daraxonrasib, zoldonrasib, elironrasib, RMC-5127, regional licensing, combination therapy

• The News: BeOne Medicines and Revolution Medicines, leaders in developing targeted therapies for RAS-addicted cancers, today announced a multi-part collaboration. This partnership includes a clinical collaboration to evaluate novel drug combinations for RAS-addicted cancers and a regional commercialization agreement, providing BeOne with exclusive rights to develop and commercialize four of Revolution Medicines’ RAS(ON) inhibitor assets in select Asian markets.
• Key Highlights:
• The collaboration focuses on evaluating drug combinations incorporating BeOne’s oncology assets with Revolution Medicines’ four clinical RAS(ON) inhibitors, which include:
  • Daraxonrasib: RAS(ON) multi-selective inhibitor.
  • Zoldonrasib: RAS(ON) G12D-selective inhibitor.
  • Elironrasib: RAS(ON) G12C-selective inhibitor.
  • RMC-5127: RAS(ON) G12V-selective inhibitor.
  • Planned studies will explore combinations such as BeOne’s MTA-cooperative PRMT5 inhibitor (BGB-58067) and EGFR x MET x MET trispecific antibody (BG-T187) with Revolution Medicines’ therapies.
• Regional Commercialization Agreement: BeOne gains exclusive development and commercialization rights for the four RAS(ON) inhibitors in select Asian markets. Revolution Medicines retains rights elsewhere, including Japan and South Korea. As part of the collaboration, Revolution Medicines will receive development and sales milestone payments and tiered royalties on net sales in the region.
• Global Phase 3 Trial:BeOne will fund and conduct a global registrational Phase 3 trial for one of Revolution Medicines’ RAS(ON) inhibitors, leveraging its robust development platform.

 

Almirall (BME: ALM) Enters Collaboration with CrystalO for Discovery and Development of Novel Small Molecules in Medical Dermatology

Key Words: Almirall, CrystalO, Ion Channel, Small Molecule, Medical Dermatology, Drug Discovery, Collaboration

• The News: Almirall announced a collaboration and licensing agreement with Shenzhen CrystalO Biopharma Technology Co., Ltd. (“CrystalO”) to jointly advance drug discovery and development for medical dermatology. The collaboration will combine CrystalO’s ion channel drug discovery platform and Almirall’s expertise in medical dermatology to develop innovative small-molecule therapies for skin diseases.
• Key Highlights:
• Scope of Cooperation:
  • CrystalO will take the lead in candidate discovery, optimization, IND-enabling studies, and early clinical development, advancing the program through proof of concept (POC).
  • Almirall will lead global development, manufacturing, and commercialization of the compounds and products, holding exclusive rights outside mainland China.
  • CrystalO will retain rights for the mainland China market.
• Financial Terms:
  • CrystalO will receive an upfront payment from Almirall, success-based payments tied to research, development, regulatory, and commercial milestones, as well as tiered royalties on future net sales outside mainland China.
  • CrystalO will pay Almirall tiered royalties based on future sales of the product in mainland China.
• Platform Profile – Ionfire^® Platform:
  • Ionfire^® Platform: An integrated small-molecule ion channel drug discovery platform combines target identification and functional screening
  • Target Focus: Focuses primarily on ion channels and other membrane proteins, which are technically challenging targets due to their structural complexity and functional diversity.
  • Development Scope: Supports the discovery workflow from target assessment and hit identification through lead optimization, IND-enabling candidate selection and preclinical candidate nomination.
• CrystalO: A China-based biotechnology company developing small-molecule therapies targeting ion channels and membrane proteins through its integrated Ionfire^® discovery platform.

 

IASO Biotechnology Acquires Singapore-Based Cell Therapy Company MediSix Therapeutics

Key Words: IASO Bio, MediSix Therapeutics, Acquisition, Cell Therapy, PEBL Platform, IASO107, PCART7, CD7 CAR-T, T-Cell Malignancies

• The News: IASO Biotechnology (“IASO Bio”) today announced the successful acquisition of MediSix Therapeutics (“MediSix”), a Singapore-based immune cell engineering and cell therapy company. This acquisition represents a significant milestone in IASO Bio’s globalization strategy, enhancing its R&D, manufacturing, and commercialization capabilities to accelerate the global development of innovative cell therapy products.
• Key Highlights:
• Core Technology: The PEBL Platform
  • MediSix’s proprietary PEBL (Protein Expression Blocker) platform seeks to address major challenges in T-cell malignancy treatments:
  • Mechanism: PEBL selectively blocks the expression of target proteins on cell surfaces, reducing fratricide among CAR-T cells. This enables MediSix’s technology to target antigens shared between T cells and target cells.
  • Applications: By combining ex vivo and in vivo CAR-T approaches, MediSix has established unique technological advantages for treating hematologic malignancies, solid tumors, and other diseases.
• About MediSix Therapeutics: Founded in 2016 and headquartered in Singapore, MediSix was established based on pioneering research by Professor Dario Campana, a globally recognized expert in translational immunology from the Yong Loo Lin School of Medicine at the National University of Singapore. He is best known for his contributions to 4-1BB (CD137) co-stimulatory domain CAR technology.

 

ArriVent (AVBP.O) Licenses Greater China Rights for ARR-002 to Shanghai Allist (688578.SH) for Up to US$ 80.6 Million

Key Words: ArriVent BioPharma, Shanghai Allist, ARR-002, AST12608, MUC16, NaPi2b, ADC, Greater China License

• The News: ArriVent BioPharma entered into an exclusive licensing agreement granting Shanghai Allist Pharmaceuticals rights to research, develop, manufacture and commercialize ARR-002, also known as AST12608, in Greater China. ArriVent retains all rights outside the licensed territory.
• Key Highlights:
• Deal Details:
  • ArriVent is eligible to receive up to US$6 million, comprising an upfront payment and development, regulatory and sales milestones.
  • ArriVent will receive tiered royalties ranging from mid-single-digit to low-double-digit percentages on annual net sales in Greater China.
• Product Profile – ARR-002:
  • ARR-002: A potential first-in-class, dual-target, tetravalent antibody-drug conjugate designed to target both MUC16 and NaPi2b.
  • Mechanism: Simultaneous targeting of MUC16 and NaPi2b is intended to enhance tumor-cell binding, internalization and payload delivery.
  • Indication Focus: Initial development is focused on ovarian and endometrial cancers, with potential application across additional solid tumors.
  • Development Stage: The FDA cleared the IND in May 2026, and first-patient dosing in a Phase I study is expected in the third quarter of 2026.

 

BioMap and Biogend Form AI-Enabled NewCo to Develop Autoimmune Bispecific and Multispecific Antibodies

Key Words: BioMap, Biogend Therapeutics, NewCo, Artificial Intelligence, Bispecific Antibody, Multispecific Antibody, Autoimmune Disease, IL-2

• The News: BioMap announced a NewCo-style technology collaboration with Biogend Therapeutics to apply its AI-powered drug discovery system to the systematic development of bispecific and multispecific antibody pipelines for autoimmune diseases.
• Key Highlights:
• Deal Details:
  • Unlike conventional NewCo transactions centered on a single licensed asset, the collaboration provides Biogend with access to BioMap’s AI discovery capabilities to continuously generate and optimize multiple antibody programs.
  • Investors: Biogend was incubated and led by Legend Capital, with follow-on investment from Temasek Life Sciences Accelerator.
• Platform Profile – BioMap AI Discovery System:
  • BioMap’s discovery system integrates its xTrimo life-science foundation models with the BioMap OS computational and experimental closed-loop platform.
  • Core Capabilities: Supports protein and antibody design, target-combination assessment, candidate generation and experimental validation.
  • Application: In this collaboration, the platform will be used to identify and optimize complex bispecific and multispecific antibody architectures for autoimmune diseases.

 

Clinical

RiboX’s Circular RNA-Based In Vivo CAR-T Candidate RXIM002 Receives FDA IND Clearance

Key Words: RiboX Therapeutics, RXIM002, Circular RNA, In Vivo CAR-T, CD19, Autoimmune Cytopenias, FDA IND

• The News: RiboX Therapeutics Ltd. (“RiboX”), a global clinical-stage biotechnology company pioneering fully engineered circular RNA (circRNA) therapeutics, announced that the FDA has cleared the IND application for RXIM002, the world’s first circRNA-based in vivo CAR-T therapy delivered through a targeted lipid nanoparticle (tLNP). This clearance enables RiboX to initiate the Phase 1 POPULUS-1 clinical trial, evaluating RXIM002 for the treatment of autoimmune cytopenias.
• Key Highlights:
• Regulatory Milestone: The FDA IND clearance allows RXIM002 to enter U.S. clinical development. RiboX notes that RXIM002 is the world’s first circRNA-based in vivo CAR therapy to achieve FDA IND clearance, representing a significant step forward for circRNA therapeutics.
• Phase I Study:The POPULUS-1 trial will evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of RXIM002 in patients with relapsed or refractory autoimmune cytopenias, initially focusing on immune thrombocytopenia (ITP).
• Product Profile – RXIM002:
  • RXIM002: An investigational, off-the-shelf in vivo CAR-T candidate designed to generate anti-CD19 CAR-T cells directly inside the body using targeted LNP-delivered circular RNA.
  • Mechanism: The candidate delivers circular RNA encoding an anti-CD19 CAR to T cells, enabling transient, non-integrating CAR expression and depletion of pathogenic B cells.
  • Indication Focus: The initial clinical focus is relapsed or refractory ITP, with broader development potential across autoimmune cytopenias and other B-cell-driven autoimmune diseases.
  • Regulatory Stage: FDA IND cleared for Phase I development in the U.S.; investigator-initiated early clinical evaluation is ongoing in China.
• RiboX Therapeutics: A global biotechnology company developing fully engineered circular RNA therapeutics for a broad range of diseases.

Rhegen Bio’s Freeze-Dried Bivalent hMPV mRNA Vaccine IND Application Accepted in China

Key Words: Rhegen Bio, hMPV, mRNA Vaccine, Bivalent Vaccine, Freeze-Dried Formulation, CDE, IND

• The News: China’s CDE accepted the IND application for a freeze-dried bivalent human metapneumovirus (hMPV) mRNA vaccine. The application, filed under acceptance number CXSL2600842, is classified as a Class 1.1 preventive biological product.
• Key Highlights:
• Regulatory Milestone: The CDE acceptance initiates the regulatory review of the clinical trial application.
• hMPV can cause upper and lower respiratory tract disease, particularly in young children, older adults and immunocompromised individuals.
• Product Profile – Freeze-Dried Bivalent hMPV mRNA Vaccine:
  • Freeze-Dried Bivalent hMPV mRNA Vaccine: an investigational, freeze-dried bivalent mRNA vaccine designed to prevent respiratory disease caused by hMPV.
  • Mechanism: Uses mRNA to instruct host cells to produce selected hMPV antigens, with the aim of inducing antigen-specific antibody and cellular immune responses.
  • Indication Focus: Intended for preventive immunization against hMPV, although the initial target age group and intended high-risk population have not been announced.
  • Formulation: Uses a freeze-dried formulation intended to improve the storage stability and transportability of the mRNA-LNP vaccine.
  • Development Stage: IND application has been accepted for review by China’s CDE.
• Rhegen Bio: A China-based biotechnology company developing mRNA therapeutics and vaccines for oncology, autoimmune diseases and major infectious diseases.

 

Hansoh Pharma (3692.HK) Initiates Phase III Trial of Fourth-Generation EGFR TKI HS-10504

Key Words: Hansoh Pharma, HS-10504, Fourth-Generation EGFR TKI, EGFR C797S, NSCLC, Phase III

• The News: Hansoh Pharma registered its first Phase III trial of HS-10504, an oral fourth-generation EGFR TKI targeting C797S-mediated resistance in advanced non-small cell lung cancer (NSCLC).
• Key Highlights:
• Clinical Data:
  • Trial Design: The randomized, multicenter, open-label Phase III study plans to enroll 206 patients with locally advanced or metastatic NSCLC harboring an EGFR C797S mutation following failure of prior EGFR-TKI therapy.
  • Study Population: The first-in-human Phase I study enrolled 82 patients across dose-escalation and expansion cohorts.
  • Primary Endpoint: The study’s primary efficacy endpoint is progression-free survival.
  • Efficacy: Among 34 efficacy-evaluable patients treated at 400 mg once daily, Hansoh reported an ORR of 52.9% and median PFS of 9.6 months.
  • Confirmed Response: Reported a confirmed ORR of 47.1% and a disease control rate of 91.2%; the difference likely reflects confirmed v overall response assessments.
  • Safety Profile: Most TRAEs were Grade 1- At 400 mg, 74.3% of patients experienced Grade≥3 TEAEs; the most common Grade ≥3 TRAEs were hematologic abnormalities.
• Product Profile – HS-10504:
  • HS-10504: An investigational, orally administered and highly selective fourth-generation EGFR TKI.
  • Mechanism: Inhibits oncogenic EGFR signaling in tumors carrying sensitizing EGFR mutations and the C797S resistance mutation, with or without the T790M mutation.
  • Dosing: The recommended Phase II dose is 400 mg orally once daily.
  • Target Population: Focuses on patients with locally advanced or metastatic EGFR C797S-mutant NSCLC following prior EGFR-TKI treatment failure.
  • Development Stage: Phase III development initiated in China; NMPA Breakthrough Therapy Designation granted in May 2026.

Biogen (BIIB.O) and TJ Biopharma Win First Global Approval for Felzartamab in China

Key Words: Biogen, TJ Biopharma, I-Mab, Felzartamab, MOR202, CD38, Multiple Myeloma, NMPA

• The News: China’s NMPA approved felzartamab in combination with lenalidomide and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy. The approval marks the first marketing authorization for felzartamab globally.
• Key Highlights:
• Regulatory Milestone: Felzartamab becomes a new anti-CD38 treatment option for previously treated multiple myeloma in China.
• Greater China Rights: In April 2026, Biogen agreed to pay TJ Biopharma US$100 million upfront and up to US$750 million in milestones, plus royalties, for Greater China rights.
• Clinical Data:
  • Registrational Study: The completed Phase III study, NCT03952091, evaluated felzartamab plus lenalidomide and dexamethasone v lenalidomide and dexamethasone alone in 289 patients with relapsed or refractory multiple myeloma after at least one prior therapy.
  • Primary Endpoint: Progression-free survival; detailed results supporting the approval have not yet been publicly disclosed.
  • Dose and Safety: The maximum tolerated dose was not reached at doses up to 16 mg/kg. The most common Grade≥3 adverse events included lymphopenia, neutropenia and leukopenia.
  • Immunogenicity: No treatment-emergent anti-felzartamab antibodies were detected in the Phase I/IIa study, although this finding requires confirmation in larger populations.
• Product Profile – Felzartamab:
  • Felzartamab: Known as MOR202 and TJ202, is a fully human IgG1 monoclonal antibody targeting CD38.
  • Mechanism: Binds CD38 expressed on malignant and pathogenic plasma cells and promotes their depletion primarily through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.
  • Administration: Felzartamab is administered intravenously. In the early Phase I/IIa study, IV infusion was completed in approximately 30 minutes; Phase III/BLA materials describe a 1.5-hour infusion schedule.
  • Indication Focus: Approved for previously treated multiple myeloma, with late-stage development focused on immune-mediated kidney diseases.
• TJ Biopharma: A China-based, fully integrated biotechnology company developing therapies for autoimmune diseases, immuno-oncology and metabolic disorders.

AstraZeneca (AZN.N) Launches Two Large Phase III Outcome Trials of Elecoglipron on Background Dapagliflozin

Key Words: AstraZeneca, Eccogene, Elecoglipron, AZD5004, GLP-1, Dapagliflozin, SGLT2, HFpEF, HFmrEF, CKD

• The News: AstraZeneca registered two large Phase III outcome trials evaluating elecoglipron added to background dapagliflozin and standard care. Elevate-HF will study cardiovascular outcomes in patients with HFpEF or HFmrEF, while Elevate-CKD will assess renal outcomes and mortality in patients with chronic kidney disease.
• Key Highlights:
• Clinical Data:
  • VISTA Weight-Loss Data: In 310 adults with obesity or overweight, elecoglipron 75 mg reduced body weight by 10.5% at Week 26 and 11.8% at Week 36, compared with 0.6% and 0.3%, respectively, with placebo.
  • SOLSTICE Glycemic Data: In 404 adults with type 2 diabetes, elecoglipron 75 mg reduced HbA1c by up to 1.9% and body weight by 7.7% at Week 26, versus 0.2% and 1.7%, respectively, with placebo.
  • Safety: Adverse events were predominantly mild-to-moderate gastrointestinal events consistent with the GLP-1 receptor agonist class. Discontinuations were infrequent, and no liver safety signal was identified.
• Product Profile – Elecoglipron:
  • Elecoglipron: An investigational once-daily oral small-molecule GLP-1 receptor agonist discovered by Eccogene.
  • Mechanism: Activates GLP-1 receptors involved in glucose-dependent insulin secretion, appetite regulation and metabolic control.
  • Indication Focus: Development covers obesity, type 2 diabetes, HFpEF/HFmrEF and CKD, including patients without diabetes in the ELEVATE outcome trials.
  • Development Stage: Elecoglipron is in Phase III development through the EMBOLD, ELUMINATE and ELEVATE programs.

Alebund’s (9637.HK) AP301 NDA Accepted in China for Dialysis-Associated Hyperphosphatemia

Key Words: Alebund Pharmaceuticals, AP301, Hyperphosphatemia, Chronic Kidney Disease, Dialysis, Phosphate Binder, NMPA, NDA

• The News: China’s NMPA accepted the NDA for AP301 capsules to treat hyperphosphatemia in chronic kidney disease patients receiving maintenance dialysis. AP301 is Alebund Pharmaceuticals’ first innovative drug candidate to reach the marketing-application stage.
• Key Highlights:
• Regulatory Milestone: The NDA acceptance initiates the regulatory review process and does not represent marketing approval.
• Supporting Study: The application is primarily supported by the 474-patient RESPOND-1 Phase III trial conducted at 50 centers in China.
• Clinical Data:
  • Study Design: RESPOND-1 was a randomized, open-label, active-controlled Phase III trial enrolling 474 maintenance-dialysis patients with hyperphosphatemia across 50 Chinese centers.
  • Treatment Groups: Patients were randomized 3:1 to AP301 or sevelamer carbonate and received dose-adjusted treatment for 52 weeks.
  • Primary Endpoint: At Week 12, serum phosphate declined by 0.72 mmol/L with AP301 and 0.70 mmol/L with sevelamer, meeting the prespecified non-inferiority criterion.
  • Long-Term Efficacy: At Week 52, mean serum-phosphate reductions were 0.76 mmol/L with AP301 and 0.72 mmol/L with sevelamer.
  • Response Rate: Serum-phosphate response rates at Week 52 were 66.7% with AP301 and 58.6% with sevelamer.
  • Safety: The most common adverse events were stool discoloration and diarrhea. No apparent iron-overload signal was observed during the 52-week treatment period.
• Product Profile – AP301:
  • AP301: An investigational oral fiber–iron-based phosphate binder classified as a Class 1 new chemical drug in China.
  • Administration: Formulated as a swallowable capsule and can be swallowed without chewing.
  • Mechanism: Its iron component binds dietary phosphate in the gastrointestinal tract, forming poorly soluble ferric phosphate that remains within the fiber matrix and is excreted in feces.
  • Indication Focus: Development currently focuses on hyperphosphatemia in CKD patients receiving maintenance hemodialysis or peritoneal dialysis.
  • Development Stage: NDA accepted for review in China; a pivotal China–US Phase III study is ongoing to support international registration.

Akeso (9926.HK) and Summit Therapeutics (SMMT.O) Announce Third NMPA Approval for Ivonescimab in First-Line Squamous NSCLC

Key Words: Akeso, Summit Therapeutics, Ivonescimab, PD-1, VEGF, Bispecific Antibody, Squamous NSCLC, NMPA, HARMONi-6

• The News: China’s NMPA approved ivonescimab in combination with chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer (NSCLC), marking the third approved lung cancer indication for an ivonescimab-containing regimen in China.
• Key Highlights:
• Regulatory Milestone: The approval marks the third NMPA-approved indication for an ivonescimab-containing regimen in China since the molecule’s initial approval in May 2024.
• The approval was supported by the China-based Phase III HARMONi-6 study, which demonstrated statistically significant improvements in both overall survival and progression-free survival over tislelizumab plus chemotherapy.
• Clinical Data:
  • Study Design: Randomized, double-blind, multicenter Phase III trial conducted in China.
  • Population: Previously untreated patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression.
  • Overall Survival: Median OS was 27.9 months with ivonescimab versus 23.7 months with tislelizumab, representing a 34% reduction in the risk of death (HR=0.66; 95% CI: 0.50–87; P=0.0017).
  • Progression-Free Survival: Median PFS was 11.1 months versus 6.9 months, representing a 40% reduction in the risk of disease progression or death (HR=0.60; 95% CI: 0.46–78; P<0.0001).
  • Safety: The overall safety profile was manageable and comparable with the tislelizumab combination arm.
• Product Profile – Ivonescimab:
  • Ivonescimab: A tetravalent bispecific antibody engineered by Akeso to simultaneously block PD-1 and VEGF-mediated signaling.
  • Mechanism: The molecule combines immune-checkpoint inhibition with anti-angiogenic activity and is designed to preferentially bind within the VEGF-rich tumor microenvironment.
  • Indication Focus: Primarily NSCLC across multiple disease settings, with broader development in colorectal, urothelial and other solid tumors.
  • Regulatory Status: Ivonescimab was initially approved in China in May 2024 and now has three approved lung cancer indications.

Laekna (2105.HK) and Qilu Pharma Announce CDE Acceptance of Afuresertib NDA in China

Key Words: Laekna, Qilu Pharmaceutical, Afuresertib, LAE002, Pan-AKT Inhibitor, Breast Cancer, NDA, AFFIRM-205

• The News: Laekna announced that China’s CDE had accepted the NDA for afuresertib in patients with locally advanced or metastatic HR-positive/HER2-negative breast cancer harboring PIK3CA, AKT1 or PTEN alterations following progression on endocrine therapy, with or without a CDK4/6 inhibitor.
• Key Highlights:
• Regulatory Status: The NDA has been accepted for review but has not yet received marketing approval.
• Potential Positioning: If approved, afuresertib could become the first domestically developed AKT inhibitor marketed in China.
• Clinical Data:
  • Study Design: Multicenter, randomized, double-blind, placebo-controlled Phase III trial.
  • Population: Patients with previously treated HR-positive/HER2-negative locally advanced or metastatic breast cancer harboring PIK3CA, AKT1 or PTEN alterations.
  • Primary Endpoint: The study met its primary PFS endpoint, demonstrating a statistically significant and clinically meaningful improvement over the control arm.
  • Safety: Laekna reported a favorable safety and tolerability profile; detailed results are expected at a future scientific conference.
• Product Profile – Afuresertib
  • Afuresertib: An oral, ATP-competitive pan-AKT inhibitor that targets AKT1, AKT2 and AKT3 and is being advanced primarily for biomarker-selected breast and prostate cancers.
  • Mechanism: It inhibits all three AKT isoforms-AKT1, AKT2 and AKT3-to suppress PI3K/AKT pathway signaling associated with tumor growth and endocrine resistance.
  • Indication Focus: Primarily biomarker-selected HR-positive/HER2-negative breast cancer, with additional development in prostate cancer.

 

Prepared by the Selesta Research Team.

research@selesta.ai

Selesta is a healthcare and life science advisory firm dedicated to serving Asia’s emerging entrepreneurs and businesses.

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