China's First Companion Diagnostic in Urological Oncology Launched: A Strategic Collaboration Between Pharma and Diagnostics Pioneers a New Trend

Recently, Gloriousmed, a provider of comprehensive oncology genetic testing solutions, and the multinational pharmaceutical company AstraZeneca announced a strategic collaboration focused on precision diagnostics for prostate cancer. This partnership marks the first strategic alliance in China to explore companion diagnostic development and co-commercialization models in the field of prostate cancer.

Notably, a leading domestic tumor NGS testing company also disclosed in its prospectus that actively exploring collaborations with pharmaceutical companies is one of its key strategic directions.Collaboration Between Genetic Testing Companies and Pharmaceutical Firms May Become the Major Trend in the Companion Diagnostics Sector, which determines whether genetic testing companies possess sustainable self-sustaining capabilities and can stand out in the sector.

As a specialized genetic testing platform with years of in-depth expertise in urological tumors, Gloriousmed leverages its proprietary genetic and multi-dimensional testing technologies to facilitate precise tumor subtyping, diagnosis, and treatment. Capitalizing on its strong capabilities in urological oncology, Gloriousmed has taken the lead in China by reaching an agreement with pharmaceutical giant AstraZeneca inJoint Development and Regulatory Filing of Prostate Cancer Homologous Recombination Repair (HRR) Gene Defect Testing Products，Academic Promotion of Precision Diagnosis and Treatment for Prostate Cancer, andPatient Assistance for Prostate Cancer Genetic TestingCollaboration Across Three Dimensions.

Ms. Yin Min, General Manager of the Oncology Business Unit, AstraZeneca Chinastated: “Precision diagnosis and treatment represent a major global trend, and companion diagnostics for oncology drugs will become increasingly important post-launch. By partnering with Gloriousmed, which possesses strong R&D capabilities, AstraZeneca can leverage complementary strengths to help clinicians prescribe anti-tumor targeted therapies correctly and effectively, ensuring patients receive accurate and compliant diagnoses for precise and effective treatment.”

As early as July this year, the National Health Commission issued the Administrative Measures for the Clinical Application of Antineoplastic Drugs (Draft for Comment). In August, the National Medical Products Administration released the Guiding Principles for Clinical Trials of Companion Diagnostic Reagents for Marketed Antineoplastic Drugs (Draft for Comment). These policy documents collectively underscore the importance of ensuring patient access to precision oncology treatments, for which precise companion diagnostics serve as a prerequisite.

Prostate cancer is the second most common malignancy in men. In 2018, approximately 100,000 new cases were reported in China. Nearly all prostate cancers that are not curatively treated will eventually progress to metastatic castration-resistant prostate cancer (mCRPC). Once patients enter the mCRPC stage, their survival time is typically limited to only 2–3 years.

In castration-resistant prostate cancer (CRPC), approximately 20% to 30% of patients harbor homologous recombination repair (HRR) gene mutations, and about 10% carry BRCA1/2 gene mutations. However, existing therapeutic options for mCRPC patients with these mutations are suboptimal, creating an urgent clinical need for novel treatments to help extend their survival.

However, the emergence of PARP inhibitors has brought the possibility of a cure to this subset of prostate cancer patients. By leveraging the "synthetic lethality" effect, PARP inhibitors can eradicate tumor cells harboring HRR mutations while simultaneously enhancing the efficacy of radiotherapy and DNA-damaging chemotherapeutic agents, thereby ushering in a new era of targeted therapy for prostate cancer.

In August 2018, olaparib, a novel drug independently developed by AstraZeneca, was approved for marketing in China, becomingChina's First Commercially Launched PARP Inhibitor, with its initial indication being ovarian cancer, the company is actively collaborating with urology experts to explore the development of this product for indications in HRR gene-mutated prostate cancer.

“To more precisely identify patients who will benefit most from olaparib therapy, we require accurate, reliable, and compliant genetic testing products,” said Ms. Yin Min. AstraZeneca has chosen to partner with Gloriousmed for this purpose. “Abroad, such genetic testing products are priced at nearly RMB 30,000. To improve accessibility for Chinese patients, locally produced companion diagnostic products at affordable prices hold greater practical significance for AstraZeneca. This is the original intention behind our collaboration with Gloriousmed.”

Unlike the traditional approach of seeking companion diagnostic collaborations after a new drug’s market launch, AstraZeneca’s partnership with Gloriousmed represents a proactive strategy to advance efficacy studies of olaparib for prostate cancer indications. This collaboration enables both parties to better share resources in clinical research and kit development and registration, thereby enhancing product reliability and accelerating regulatory approval. Meanwhile, the two companies will also initiate early market education on genetic testing for prostate cancer, aiming to expedite the widespread adoption of standardized precision diagnosis and treatment models in this field.

“AstraZeneca’s existing drug pipeline is already robust, but we still need integrated solutions for patient diagnosis and treatment,” emphasized Ms. Yin Min. “From disease education, early screening, biopsy, and AI-assisted interpretation to postoperative medication, long-term follow-up, and rehabilitation, the entire care continuum cannot be covered by a single pharmaceutical company alone; rather, it requires collaborative advancement with leading partners across various fields.”

Over the past few years, AstraZeneca has collaborated with governments, hospitals, and partners to establish multiple integrated innovation centers for the diagnosis and treatment of prostate cancer. These initiatives aim to facilitate early detection, diagnosis, and treatment of prostate cancer, thereby extending patient survival and improving quality of life.

“Gloriousmed and AstraZeneca share the same philosophy: we are both patient-centric, providing patients with the most effective support and decision-making assistance throughout the entire diagnostic and treatment journey.”Ms. Jin Ge, CEO of Gloriousmedstated, “Gloriousmed’s technological strength in the field of tumor detection, combined with AstraZeneca’s global layout in drug R&D, makes us the undisputed best partners.”

The comprehensive collaboration between AstraZeneca and Gloriousmed in the field of prostate cancer enables the integration of genetic screening specifically tailored for patients with advanced prostate cancer into their existing theranostic platform. This provides a basis for precise targeted therapy for patients with HRR or BRCA1/2 mutations, not only facilitating the precise targeted treatment of advanced prostate cancer with olaparib but also achieving whole-course disease management for prostate cancer patients, thereby significantly improving overall survival in this population.

Furthermore, companion diagnostics can assist physicians in making more precise treatment decisions and identifying the most effective therapeutic regimens for patients; from another perspective, this also helps conserve health insurance funds and social resources. “Therefore,In addition to pairing quality instruments with quality reagents, I believe that high-quality testing is also essential..” Ms. Yin Min concluded.

Clinical Experts in Urology Attend the Signing Ceremony as Witnesses

Currently, the primary healthcare needs in China have undergone profound changes. There are over 10,000 county-level hospitals across the country, serving county residents (including rural and small-town populations), who account for 70% of the national total. Particularly since the onset of the pandemic, patient visits to county-level hospitals have increased year by year. However, due to the lack of subspecialization within their oncology departments, these hospitals indeed face challenges such as outdated diagnostic and treatment concepts and a lack of standardized care protocols. There is an urgent need to standardize diagnosis and treatment at different disease stages and implement whole-disease-process management.

Therefore, through its collaboration with Gloriousmed, AstraZeneca leverages its mature Integrated Diagnosis and Treatment Centers and extensive county-level teams to work in concert with partners, driving engagement from top to bottom and penetrating grassroots markets. This initiative aims to disseminate the concept of precision diagnosis and treatment down to the primary care level. By utilizing collaborative models such as Medical Consortia, the partnership seeks to gradually achieve nationwide standardization of testing and integration of diagnosis and treatment, thereby transforming standardized therapy from mere guideline recommendations into realized, nationwide quality control management for prostate cancer.

In conclusion, Ms. Jin Ge remarked, “With the advent of the digital healthcare era, an increasing number of novel oncology therapies are being developed. We embrace these changes, which also necessitate collaboration with more industry partners whose technologies have proven reliable, so as to enhance technology accessibility and ensure that patients truly benefit.”