Suzhou GenoBiotech Advances Precision Oncology with Novel HER2-Targeted Radiopharmaceutical ADAPT6 and Expands Pipeline of Innovative Nuclear Medicines
Cancer continues to pose a challenge to humanity.
According to the latest global cancer data released by the International Agency for Research on Cancer (IARC) of the World Health Organization, the estimated number of new cancer cases worldwide in 2020 totaled 19.29 million. Among them, China accounted for 23.7% of the total, becoming the country with the highest number of new cancer cases globally.
In the face of cancer challenges that remain unconquered, early screening and early treatment have become a “lifeline” for patients. On January 12, 2022, Suzhou Zhihe Biotechnology and Sweden’s Hoberbiotech officially announced their collaboration on99mExclusive Licensing Agreement Reached for Tc-Labeled Her-2-Targeted Radiopharmaceutical Imaging Agent ADAPT6 in Greater China. It is reported that this imaging agent can rapidly differentiate between Her-2(+) and Her-2(-) tumors. Her-2 is a critical therapeutic target for breast cancer patients. Furthermore, its expression status is also highly significant for the diagnosis and treatment of other solid tumors, such as gastric cancer and lung cancer.
“ADAPT6 aligns perfectly with Zhihe Bio’s nuclear medicine product pipeline. We have always adhered to a development philosophy centered on independent R&D, supplemented by global collaboration, to jointly promote sustainable innovation in the field of nuclear medicine,” stated Dr. Xu Tao, Founder and CEO of Zhihe Bio. He added that the company will continue to leverage its continuously optimized nanobody platform technology to develop radiopharmaceuticals targeting well-established oncology indications, while gradually establishing manufacturing facilities and sales teams to facilitate its transition from a biotechnology company to a biopharmaceutical enterprise.
The breast, gastric, and lung cancers targeted by ADAPT6, introduced by Zhihe Bio, have become major public health issues in society today.
According to data from the World Health Organization’s International Agency for Research on Cancer (IARC), there were 2.26 million new cases of breast cancer globally in 2020, accounting for approximately 11.7% of all new cancer cases. This marked the first time that breast cancer surpassed lung cancer to become the most commonly diagnosed cancer worldwide. Meanwhile, the incidence rates of lung cancer and gastric cancer also remain significant, with 2.20 million and 1.09 million new cases, respectively.
In the absence of effective therapeutic options, achieving early diagnosis of tumors has become a key focus of clinical research. It is reported that HER2 expression status is a critical biomarker for the early diagnosis of breast cancer, with approximately 20% of primary breast cancers exhibiting HER2 gene amplification or protein overexpression.
Currently, both domestic and international guidelines recommend HER2 testing for all newly diagnosed breast cancer cases. Specifically, the rate of discordance in HER2 expression between primary breast cancer tumors and metastatic lesions is approximately 5%–13%, while in gastric cancer it is around 5%–18.4%. Therefore, repeated assessment of HER2 expression levels during patient diagnosis and treatment is essential to achieve precision medicine. Consequently, for patients with recurrent or metastatic disease, if tumor tissue is accessible, guidelines recommend performing HER2 testing on the recurrent or metastatic lesions.
For such a critical biomarker in tumor diagnosis and treatment, the traditional HER2 detection method—immunohistochemistry (IHC)—requires invasive procedures such as surgery or needle biopsy to obtain tissue samples. This not only inflicts both psychological and physical trauma on patients but also precludes repeated sampling over short intervals. Furthermore, the test results only reflect the expression levels in the locally sampled tissue. Consequently, IHC merely captures HER2 expression at a specific point in time and location, making it difficult to assess the overall tumor landscape.
Meanwhile, the ADAPT6 introduced by Zhihe Bio utilizes99mTc/68Ga-labeled scaffold protein targeting HER-2 enables real-time, dynamic visualization of HER-2 expression levels in all tumors throughout the body via SPECT/PET-CT. The entire procedure is non-invasive and clinically straightforward, with imaging results available to patients within just a few hours. Compared to traditional detection methods, which typically require approximately 1–2 weeks to issue reports, this approach significantly enhances patients’ opportunities for timely diagnosis and treatment.
More notably, molecular imaging leverages the advantages of staged, repeated assessments to enable real-time detection of metastatic lesions, which are common during tumor progression. This allows patients at risk of recurrence to receive more effective treatment in the shortest possible time, thereby maximizing disease-free survival.
It is reported that ADAPT6 was jointly developed by Vladimir Tolmachev and Sophia Hobe from Uppsala University and the Royal Institute of Technology in Sweden. After more than a decade of research and optimization, over 30 high-impact SCI papers have been published on the subject. The drug has currently completed Phase I clinical trials. In patients with untreated primary breast cancer, study results demonstrated that ADAPT6 exhibits a favorable safety profile with no related adverse events reported, and it enables rapid differentiation between Her-2(+) and Her-2(-) tumors within 2 hours after injection.
From left to right: Molecular structure of ADAPT6, Tumor-to-contralateral breast ratio at 2 hours after ADAPT6 injection, and Whole-body imaging at 2 hours after ADAPT6 injection
In addition to its applications in the diagnosis and treatment of breast cancer and gastric cancer, the value of HER2 in the management of non-small cell lung cancer (NSCLC) and bladder cancer is gradually being recognized. In the future, ADAPT6 will undoubtedly facilitate early screening and early intervention for these cancers through molecular imaging.
In fact, alongside the introduction of ADAPT6, Zhixin Biologics’ self-developed radiopharmaceuticals are also advancing rapidly. The company has independently developed radioactive isotopes68Ga-labeled PD-L1 expression imaging agent (SNA002) and whole-body tumor-infiltrating lymphocyte (TIL) imaging agent (SNA006): Both imaging agents share advantages similar to those of ADAPT6, offering significant guidance and development value for clinical cancer immunotherapy.
According to Dr. Xu Tao, SNA002 is poised to simultaneously initiate Investigational New Drug (IND) applications in both China and the United States, with the potential to become the first radiopharmaceutical diagnostic agent from a Chinese innovative pharmaceutical company to conduct registration-enabling clinical studies in the U.S. in nearly a decade. In addition, Zhihe Biotechnology has partnered with the First Affiliated Hospital of Soochow University to launch an investigator-initiated clinical trial for SNA006.
While continuing to deepen its development of radiopharmaceutical imaging agents to meet the needs of early cancer screening and treatment, Zhihe Biotech is also focusing on radiopharmaceuticals for cancer therapy.
“We aim to bring new hope to patients with the most innovative nuclear medicine diagnostic and therapeutic products.” Discussing the mission of Zhihe Biopharma, Dr. Xu Tao stated that the company has currently established a pipeline of radiopharmaceuticals for nuclear medicine therapy, offering more effective radioactive therapeutics following precise diagnosis.
From the perspective of industry insiders, radiopharmaceuticals can deliver radionuclides to tumor tissues using optimized carriers, enabling selective irradiation of the tumors while minimizing toxicity to surrounding healthy tissues, thereby achieving precise targeted cancer therapy. Furthermore, radiopharmaceuticals remain effective in exerting cytotoxic effects against tumors that have developed resistance to other treatment modalities, offering patients greater hope for successful outcomes.
Leveraging these advantages, multinational pharmaceutical companies such as Novartis and Bayer have already deployed radiopharmaceuticals in fields including neuroendocrine tumors and prostate cancer. Zhihe Biotech has also established a multi-pronged R&D pipeline in related areas.
IntelliCore Biologics Product Pipeline
Throughout this process, the proprietary technology platforms of Zhihe Bio have been continuously refined. The company has currently established three major technology platforms—SmartSdbc, SmartApa, and SmartRel—achieving seamless integration of radioisotopes with nanobodies while circumventing the inherent renal metabolism drawbacks associated with nanobodies themselves. By fully leveraging the advantages of nanobodies, such as their small molecular weight and strong tissue penetration capabilities, the company has developed a series of radiopharmaceuticals for diagnosis and therapy with superior efficacy. Dr. Xu Tao also revealed that the company will utilize these technology platforms to continuously develop radiotherapeutic drugs targeting well-established tumor antigens, thereby comprehensively accelerating the R&D pipeline and enabling scalable production.
SmartSdbc, SmartApa, and SmartRel: The Three Major Technology Platforms of Zhihe Bio
“Due to technical barriers, the development of innovative radiopharmaceuticals in China has been slow over the past decade. Only a very small number of radiodiagnostic agents have entered clinical use, while the field of therapeutic radiopharmaceuticals remains largely unexplored. In the past two years, global R&D in radiopharmaceuticals has gained significant momentum. Although China still lags considerably behind Europe and the United States, the fact that R&D in this field is still in its early stages globally provides China with a late-mover advantage, offering the potential to catch up,” stated Dr. Xu Tao.
Additionally, Zhihe Biopharma is currently constructing a GMP-compliant facility for conjugation and radiopharmaceutical production, spanning nearly 10,000 square meters. The facility is expected to be completed and ready for operation by the end of 2022. Meanwhile, the company’s specialized sales team will also be established in 2022, preparing for the commercial launch of SNA001, Zhihe’s first nuclear medicine diagnostic and therapeutic product. These efforts will support Zhihe Biopharma in achieving full-process coverage from independent R&D and manufacturing to sales, thereby facilitating its transformation from a biotechnology company into a biopharmaceutical enterprise.