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

- Link: https://www.thailand-business-news.com/pr-news/cstone-pharmaceuticals-enters-into-exclusive-commercialization-agreement-with-arrotex-for-sugemalimab-across-australia-and-new-zealand
- Published: 2026-06-25T16:44:00+07:00
- Author: PR Newswire

◦ 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](https://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](http://www.arrotex.com.au/).

**Forward-looking statements**

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_Disclaimer: only for communication and scientific use by medical and health professionals,
it_ _is not intended for promotional purposes._

 

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