CStone Pharmaceuticals Enters into Exclusive Commercialization Agreement with Arrotex for Sugemalimab across Australia and New Zealand

• Arrotex, the pharmaceutical commercialization platform of DBG, Australia's leading diversified healthcare group, will be responsible for the registration, market access, and commercialization of sugemalimab in Australia and New Zealand.
• This partnership marks sugemalimab's fifth international commercialization partnership, further expanding the product's global footprint.
• CStone will receive an upfront payment and is eligible for regulatory and commercial milestone payments. CStone will supply sugemalimab to Arrotex and recognize a profit share arrangement.

SUZHOU, China, June 25, 2026 /PRNewswire/ -- CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, immunology, inflammation, and other key disease areas, today announced that it has entered into an exclusive commercialization agreement with Arrotex Pharmaceuticals Pty Ltd ("Arrotex"), a core pharmaceutical commercialization platform of DBG Health ("DBG"), Australia's largest diversified healthcare group, for the commercialization of sugemalimab in Australia and New Zealand.

Under the terms of the agreement, CStone will receive an upfront payment from Arrotex and is eligible for additional regulatory and commercial milestone payments. CStone will supply sugemalimab to Arrotex and recognize a profit share arrangement.

Arrotex will hold exclusive commercialization rights for sugemalimab in Australia and New Zealand across all approved and future indications, including stage III and IV non-small cell lung cancer (NSCLC), gastric cancer (GC), esophageal squamous cell carcinoma (ESCC), and extranodal NK/T-cell lymphoma (ENKTL), subject to regulatory approval by Australia's Therapeutic Goods Administration (TGA). Arrotex will be responsible for regulatory submissions and commercialization activities in the licensed territory.

Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated: "This agreement with Arrotex marks another milestone in the global commercialization of sugemalimab, successfully extending its commercialization reach into the Oceania region. Australia and New Zealand are well-established pharmaceutical markets with regulatory frameworks closely aligned with those of the EU and US. As the core commercialization platform of DBG, Arrotex's commercialization infrastructure and established pharmacy network position is well placed to support the introduction of sugemalimab in these markets. Building on sugemalimab's existing approvals in the EU and the UK for stage III and IV NSCLC, this collaboration provides a clear and efficient regulatory pathway for Australia and New Zealand. This milestone brings sugemalimab's global commercial footprint to five strategic partnerships, covering over 60 countries and regions across Europe, the Middle East and Africa, Latin America, and Oceania."

Dennis Bastas, Chairman and Group Chief Executive Officer of DBG Health, the parent company of Arrotex Pharmaceuticals, said: "We are excited to be partnering with CStone to bring this innovative therapy to Australia and New Zealand. This partnership enables early commercial planning for CStone's product while bringing together two organisations with a shared commitment to improving outcomes for people affected by cancer." Mr Bastas added, "Arrotex's deep expertise in regulatory engagement, market access, and distribution across Australia and New Zealand – combined with CStone's strong development capabilities – positions us well to accelerate access to this important new treatment for patients across multiple indications."

About Sugemalimab

The anti-PD-L1 monoclonal antibody sugemalimab was developed by CStone using OmniRat^® transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.

The EC and MHRA have approved sugemalimab for two indications:

• In combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations; and
• Monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 expression on ≥1% of tumor cells and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based CRT.

The National Medical Products Administration (NMPA) of China has approved sugemalimab for five indications:

• In combination with chemotherapy as first-line treatment of patients with metastatic squamous and non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations and metastatic squamous NSCLC;
• For the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based CRT;
• For the treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma;
• In combination with fluorouracil and platinum-based chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC; and
• In combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression CPS ≥5.

ESMO Guidelines recommend sugemalimab [I, A] for:

• In combination with platinum-doublet chemotherapy as first-line treatment for non-oncogene-addicted stage IV patients with squamous NSCLC, performance status (PS) 0-1, regardless of tumor PD-L1 status and without contraindications for immune checkpoint inhibitors (ICI);
• In combination with platinum-based chemotherapy as first-line treatment for patients with non-squamous NSCLC, PS 0-1, regardless of tumor PD-L1 status and without contraindications for ICI; and
• Consolidation therapy for up to 24 months in patients with stage III NSCLC, who are EGFR wild-type and lack ALK or ROS1 genomic aberrations, following concurrent or sequential chemoradiotherapy without disease progression.

About CStone

CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, immunology, inflammation, and other key disease areas. Dedicated to addressing patients' unmet medical needs in China and globally, the Company has made significant strides since its inception. To date, the Company has successfully launched 4 innovative drugs and secured approvals for 21 new drug applications covering 9 indications. The company's pipeline is balanced by 16 promising candidates, featuring antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies and precision medicines. CStone also prides itself on a management team with comprehensive experiences and capabilities that span the entire drug development spectrum, from preclinical and translational research to clinical development, drug manufacturing, business development, and commercialization.

For more information about CStone, please visit: www.cstonepharma.com. 

About Arrotex

Proudly Australian owned and part of DBG Health, Arrotex Pharmaceuticals is Australia's largest and most diversified pharmaceutical company, offering the most extensive range of prescription medicines across therapeutic areas. We are committed to ensuring timely, sustainable, and affordable healthcare solutions that enhance patient outcomes and support healthcare providers. With unmatched expertise in pharmacy and healthcare, Arrotex continues to invest in Australia's healthcare ecosystem, delivering trusted medicines, innovative programs, and strategic partnerships that create real value for patients, healthcare providers, and partners. For more details about Arrotex, visit www.arrotex.com.au.

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SOURCE CStone Pharmaceuticals