Jilang Biotech Pioneers Non-Invasive Rapid Testing Technology for Female Hormones in Reproductive Health
Female reproductive health is a current focal point in the medical field, with eugenics and healthy childbirth being a key subject within this domain. Currently, issues in the field of female reproductive health are increasingly prevalent, yet clinical diagnostic and therapeutic approaches remain relatively limited. There is an urgent clinical need for novel diagnostic and treatment methods and technologies in this area.
Driven by the substantial market demand in the field of female reproductive health, Mr. Zhu Shuhan, founder of Nanjing Jilang Biotechnology Co., Ltd., and his team keenly seized this opportunity. Starting from clinical pain points, they promptly developed “New Technology for Non-Invasive and Rapid Detection of Female Hormones“series products. Mr. Zhu Shuhan, with nearly three decades of experience in the pharmaceutical industry, believes that with the introduction of favorable policies such as the national encouragement of the two-child policy, the future market for women's reproductive health is expected to have enormous potential. Accordingly, he joined forces with two doctors who have achieved significant results in the fields of medical diagnostics and immunoassay analysis to jointly establish a research and development platform for in vitro diagnostic reagents.”
Dr. Gu, CTO of Jilang Biotech
As outstanding leaders of the Jilang R&D team, one PhD holder serves as a Senior Research Fellow at the Faculty of Medical and Health Sciences, University of Auckland, a doctoral supervisor, and Chief Scientist at the School of Pharmacy. With over two decades of research experience in medical analysis, drug metabolism, and bioimmunology, this individual possesses extensive R&D and innovation expertise, particularly in the metabolism of anticancer drugs and the relationship between hormone metabolism and cancer. The other PhD holder is a Senior Research Fellow at the Royal Society Te Apārangi (Royal Society of New Zealand) and a doctoral supervisor, with rich experience in the fields of biosensors and immunoassay kits. This individual participated in the development of the world’s first portable ovulation monitor and initially achieved the industrialization of this technology.
The encounter of the three individuals marked the beginning of Jilang Biotech’s story. “Although early-stage point-of-care testing (POCT) products for female hormone monitoring already exist abroad, both product development and clinical awareness in China remain relatively lagging. The addition of two senior biomedical PhDs has further strengthened our confidence in strategically positioning ourselves in the field of women’s reproductive health and becoming a leader in the research and development of new clinical laboratory technologies in this area,” said Mr. Zhu Shuhan.
Proprietary patented products developed in-house are the cornerstone of a company’s success. In 2014, Mr. Zhu Shuhan co-founded Nanjing Jilang Biotechnology Co., Ltd. (hereinafter referred to as “Jilang Biotech”) with two PhD holders. Since its inception, the company has been committed to deep cultivation in the field of women’s reproductive health. As an R&D-driven high-tech enterprise, Jilang Biotech embarked on its journey with a new technology project for female hormone monitoring, and through years of dedicated efforts,Successfully developed the “Non-invasive Rapid Test Kit for Female Hormone (PdG)” with independent intellectual property rights.。
Female hormone levels are inextricably linked to female reproductive health; therefore, rapid and accurate monitoring of relevant hormones is the primary step in ensuring eugenics and healthy childbearing.
Currently, international development has begunNon-invasive Techniques for Female Hormone MonitoringandAnalysis Techniques for Curve Relationships Among Different HormonesNon-invasive techniques for monitoring female hormones enable continuous surveillance, thereby generating trend curves of hormonal fluctuations. Analytical methods examining the interrelationships among these curves facilitate the establishment of female hormone profile data. The integration of these technologies enhances the accuracy and efficacy of clinical assessments of female hormonal health.
Based on this, the R&D team at Nanjing Jilang Biotechnology Co., Ltd. focused on non-invasive, rapid monitoring of PdG, E3G, and other hormonal markers to develop a series of products tailored to clinical needs in women’s reproductive health. This innovation marks the first breakthrough in China to integrate multifunctional dynamic monitoring technologies for pre-conception diagnosis, fertility assistance, and post-conception monitoring and guidance, thereby filling a gap in the field of women’s reproductive health monitoring in China.
Progesterone is a steroid hormone secreted by the corpus luteum of the female ovary, also known as progestogen. NANJING JILANG BIOTECHNOLOGY CO.,LTD employs fluorescence immunochromatography to detect the level of pregnanediol glucuronide, a progesterone metabolite in female urine, thereby rapidly and accurately indicating the progesterone level in the subject’s body.Dr. Gu, CTO of the CompanyIntroduction: "Progesterone is released in a pulsatile manner in the body. Therefore, serum progesterone levels measured clinically can vary significantly depending on the timing of blood sample collection. To accurately assess progesterone levels in the human body, a more accurate and effective approach would be to obtain the mean value of progesterone over a certain period following its pulsatile release. However, current clinical detection methods are unable to provide an accurate measurement of progesterone levels."
Dr. Gu added, “The progesterone metabolite detection kit independently developed by NANJING JILANG BIOTECHNOLOGY CO.,LTD precisely addresses this pain point in clinical diagnosis. By rapidly and accurately measuring (fully quantitative) the levels of progesterone metabolites in female urine, the kit reflects the average level of endogenous progesterone secretion over a specific period. As a non-invasive test, it enables patients to perform continuous daily monitoring, with data automatically uploaded to the cloud each time to generate physiological cyclical curves, thereby integrating reproductive health monitoring for women both before and after pregnancy.”
Clinical Application of Non-Invasive Progesterone Detection Technology
Clinically, progesterone testing can effectively determine the ovulation period, assist in diagnosing infertility, and help prevent early miscarriage. It also aids physicians in diagnosing amenorrhea and anovulatory menstruation associated with polycystic ovary syndrome (PCOS), as well as assessing luteal function and placental function in pregnant women. Jilang Biotechnology’s non-invasive point-of-care testing (POCT) for progesterone extends progesterone monitoring from hospital settings to home use, enabling patients to perform these tests in the comfort of their own homes.
Currently, Jilang Biotechnology's non-invasive point-of-care testing (POCT) project for female hormone monitoring has been granted a national patent in China and has filed an international PCT patent application. Its corresponding test kits and instruments are classified as Class II medical devices, and the company is currently conducting clinical trials for progesterone metabolite (PdG). The company's series of female hormone detection products is expected to obtain approval from the National Medical Products Administration (NMPA) this year.
According to information disclosed on the official website of NANJING JILANG BIOTECHNOLOGY CO.,LTD, the company has currently launched several fluorescence immunochromatographic assay products, including progesterone (PROG), human chorionic gonadotropin (HCG), anti-Müllerian hormone (AMH), and pregnanediol-3-glucuronide (PdG), catering to women with diverse testing needs. Notably, the company’s website also lists an inflammation panel comprising the following kits: C-reactive protein (CRP) assay kit, procalcitonin (PCT) assay kit, serum amyloid A (SAA) assay kit, and a combined SAA-CRP dual assay kit.
Jilang Biotechnology's Business Layout
Mr. Zhu Shuhan, the founder, explained that Jilang Biotechnology primarily focuses on diagnostic kits for women’s health. In the future, the company will center its efforts on the research and development of diagnostic kits related to women’s health, while also expanding its pipeline to cover other indications, such as point-of-care testing (POCT) products for inflammation, cardiac markers, renal function, and blood glucose monitoring.
In 2014, NANJING JILANG BIOTECHNOLOGY CO.,LTD was established at the National Industrial Base of Jiangsu Life Science and Technology Innovation Park in Nanjing Qixia Economic and Technological Development Zone. In 2015, the company introduced strategic investors, including industry-renowned Ma Yinglong Pharmaceutical and Shenzhen Bao’an Group, co-established a joint laboratory with the Chinese Academy of Sciences, and set up a clinical research cooperation base with Southeast University. In 2017, Jilang Biotech brought in strategic investment shareholders such as Xiantong Capital and Hubei High-Tech Investment, fully acquired Nanjing Yafang Pharmaceutical Co., Ltd., and relocated to the Intelligent Manufacturing Industrial Park in Nanjing Jiangbei New Area, thereby enhancing its R&D system and transformation platform.
Currently, NANJING JILANG BIOTECHNOLOGY CO.,LTD has launched a new round of A+ financing plan, which is mainly used to rapidly advance the clinical trials of the company's core test kits and the construction of the marketing system for new products. According to the existing plan, the company will complete the registration of its series of products by the end of 2021 and achieve market launch of the new products.