China's First Commercialization Partnership for Thyroid Cancer Theranostic Drug Announced

Recently, Suzhou Smart Nuclear Biological Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “SmartNuclide”) and Shenzhen China Resources Gosun Pharmaceuticals Co., Ltd. (hereinafter referred to as “China Resources Gosun”) jointly signed a business cooperation agreement. The two parties will collaborate on the first domestic rhTSH (brand name: Zhishujia^®) collaborate on commercial promotion after obtaining approval from the NMPA (National Medical Products Administration). Through this collaboration, China Resources Gosun will obtain Zhishujia^®Exclusive marketing rights in the Chinese thyroid and breast surgery market.

There are 221,000 new cases of thyroid cancer annually, with differentiated thyroid cancer accounting for approximately 95%. The standard treatment for differentiated thyroid cancer involves surgical resection, radioactive iodine-131 therapy, and thyroid hormone suppression therapy. However, both postoperative diagnostic procedures and iodine-131 therapy require elevated levels of thyroid-stimulating hormone (TSH), and no approved medication is currently available for this indication in mainland China. Zhishujia^®It is recombinant human thyroid-stimulating hormone (rhTSH), with the development code SNA001, which can rapidly increase TSH levels in the body. Potential indications include adjuvant therapy for iodine-131 ablation of residual thyroid tissue after total or near-total thyroidectomy in patients with differentiated thyroid cancer (DTC) without distant metastasis, as well as auxiliary diagnosis using serum thyroglobulin (Tg) during follow-up after thyroidectomy in patients with differentiated thyroid cancer. In July 2022, Zhishujia^®The New Drug Application (NDA) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. It is currently in the process of submitting supplementary materials and undergoing quality standard review, with market approval imminent.

Xu Tao, General Manager of SmartNuclideRepresented by: Zhishujia^®This is SmartNuclide’s first commercialized drug. Its market launch will end the current lack of available medications for patients with differentiated thyroid cancer during the preparation phase for radioactive iodine therapy, thereby transforming the current landscape of thyroid cancer diagnosis and treatment and providing more therapeutic options for the vast number of thyroid cancer patients in China. Shenzhen China Resources Gosun Pharmaceuticals Co., Ltd., a subsidiary of the state-owned enterprise China Resources Group, possesses a systematic and professional marketing framework. We are delighted to have entered into this collaboration with Shenzhen China Resources Gosun Pharmaceuticals and look forward to efficient synergy between both parties to maximize the potential of Zhishujia.^®clinical value, benefiting a broad population of thyroid cancer patients.

Tu Feina, General Manager of China Resources GosunStatement: Over the past 32 years since its establishment, China Resources Gosun has always adhered to the philosophy of “everything for the health of patients,” fulfilled the social responsibilities of a central state-owned enterprise, and provided high-quality medicines to the public. Zhishujia^®It is a thyroid cancer diagnostic and therapeutic drug with clinical differentiation advantages. Its value proposition aligns well with Shenzhen China Resources Gosun Pharmaceuticals’ strategic expansion in perioperative care. We are delighted to collaborate with SmartNuclide, an innovative radiopharmaceutical company, to inject new momentum and vitality into the future development of drugs in the thyroid cancer field.

ZhiShuJia^®(rhTSH, Recombinant Human Thyrotropin for Injection) Its main component is recombinant human thyrotropin (rhTSH), a glycoprotein of the same class as human thyroid-stimulating hormone (TSH), with an identical amino acid sequence. Zhishujia^®Early clinical trial results showed that the drug was well tolerated with a favorable safety profile, comparable to recombinant human TSH (rhTSH) already marketed abroad under the brand name Thyrogen^®) Highly consistent PK parameters (Front Endocrinol. 2021 Feb 17).

Since December 2019, SmartNuclide has conducted a large-scale, randomized, open-label, multicenter, parallel-controlled Phase III clinical trial to demonstrate that recombinant human thyroid-stimulating hormone (rhTSH) injection is non-inferior to thyroid hormone withdrawal (THW) in postoperative radioactive iodine-131 (¹³¹I) therapy for patients with differentiated thyroid cancer (DTC). The study results showed that, compared with the THW group, rhTSH was non-inferior to THW in terms of ¹³¹I remnant ablation efficacy, significantly shortened the waiting time for ¹³¹I therapy, and avoided adverse reactions associated with hypothyroidism such as fatigue, asthenia, and cold/heat intolerance. It demonstrated good safety and tolerability, addressing a clear clinical need and offering significant value. In addition, Zhishujia^®Utilizing a pre-filled syringe formulation, the process is stable and more convenient for clinical operation.

Suzhou SmartNuclide, established in 2015, is a nuclear medicine company committed to its mission of “bringing new hope to patients through the most innovative nuclear medicine diagnostic and therapeutic products.” It is dedicated to providing innovative radiopharmaceuticals for diagnosis and therapy to patients worldwide.

SmartNuclide has established a proprietary technology platform for the discovery, R&D, and manufacturing of radiopharmaceuticals based on single-domain antibodies. In accordance with cGMP standards, the company has constructed and commissioned a multi-thousand-square-meter GMP-compliant radiopharmaceutical production facility (Class B qualification). SmartNuclide has proactively laid out a pipeline of more than 10 innovative radionuclide-based diagnostic and therapeutic products. It has developed China’s first recombinant human thyroid-stimulating hormone (rhTSH, Zhishujia^®) The New Drug Application (NDA) has been submitted and accepted, with approval for market launch expected in the near future, thereby filling a therapeutic gap in mainland China. Multiple innovative radiopharmaceuticals for tumor imaging have progressively entered clinical trials, while potential molecular candidates for novel-targeted radiotherapeutic agents have been identified, with clinical trials set to commence shortly.

Shenzhen China Resources Gosun Pharmaceuticals Co. Ltd, established in 1991, is a pharmaceutical enterprise integrating research and development, manufacturing, and sales, with a focus on anti-infectives and the perioperative field. In the perioperative sector, the company received approval in June 2021 to market Mitoxantrone Hydrochloride Injection for Tracing (Futashu), the first product in China formally approved for tracing drainage lymph nodes in the thyroid surgical region. Meanwhile, it continues to expand and strengthen its product pipeline in strategic perioperative areas.