Norroy Medicine: Focusing on original research and innovation, a new force of domestic nuclear medicine is rising
Recently, Norroy Pharmaceutical received an exclusive interview with I · Campus of Wuxi International Life Science Innovation Park. The original text is as follows:
The column "I · Campus Star Interview with Stars of Innovation Highland", through an exclusive interview with star enterprises and new star enterprises in Wuxi International Life Science Innovation Park, reveals the successful experience behind the rise of "industry stars", listens to the research and development ideas of "innovation stars", looks forward to the beautiful vision of the development of the biomedical industry based on Wuxi High tech Zone, and talks about the new actions and new patterns of enterprises in the new era. Background
➤ What is "nuclear medicine"?
Nuclear medicine, that is, special drugs containing radionuclides used in nuclear medicine for diagnosis and treatment, is also known as radiopharmaceuticals. Radiopharmaceuticals can reflect the pathological gene, molecule, metabolism and functional status by using the biological characteristics of the vector they label, and can have a more early and specific insight into the molecular level information of the disease. At the same time, they can also use the radiation energy of radionuclides to kill tumors accurately. At present, they have become a powerful means for early diagnosis and precise treatment of diseases.
➤ Industry development background
With the support of China's medical equipment allocation policy, the rapid construction of nuclear medicine department, and the release of the first domestic programmatic document for nuclear technology in the field of medical and health applications in 2021, the Medium and Long Term Development Plan for Medical Isotopes (2021-2035), the industry development path will be gradually paved at the macro level.
In terms of research and development of diagnostic nuclear drugs, CDE issued the Guiding Principles for Clinical Evaluation of Radioactive in vivo Diagnostic Drugs and the Guiding Principles for Non clinical Research of Radioactive in vivo Diagnostic Drugs in October 2020 and February 2021, respectively, to promote and standardize the research and development of radioactive in vivo diagnostic drugs in China. With the continuous development of radioactive in vivo diagnostic drugs, more and more radioactive in vivo therapeutic drugs have entered the clinic, and the policy support of the nuclear drug industry has gradually expanded to promote the clinical research of radioactive in vivo therapeutic drugs.
The state has sent a series of positive signals, such as encouraging private enterprises to participate in nuclear and promoting the development of nuclear medicine, and the industry is changing.
Issue 5 - Interviewers
Yan Chenglong
❖ Co founder and General Manager of Wuxi Norroy Pharmaceutical Technology Co., Ltd
❖ Master of Pharmacy, Jiangnan University
❖ More than 10 years of experience in R&D and commercialization of nuclear medicine related products
❖ Deputy General Manager of Yuanmidu (Nanjing) Biotechnology Co., Ltd
Initial impression of the enterprise
➤ Wuxi Norroy Bioscience CO., LTD
Wuxi Norroy Bioscience CO., LTD (hereinafter referred to as norroy) was established in July 2021. The company has established a research and development team of nearly 50 people composed of high-level talents at home and abroad, and has the necessary software and hardware conditions for innovative nuclear drug research and development and innovative drug transformation. Based on the integration of nuclear medicine diagnosis and treatment, facing the major unmet clinical needs of renal cancer, prostate cancer, pancreatic cancer and other tumors in the urinary and digestive tract, the company conducts strategic layout around two dimensions of new targets and mature targets, independently builds a nuclear medicine software and hardware research and development platform and owns global intellectual property rights, aiming to establish a world-class innovative nuclear medicine screening and research and development system, It is one of the few R&D enterprises with independent intellectual property technology platform in China that specializes in original research and innovative nuclear drug development.
Up to now, norroy has completed the molecular design screening of more than 10 targets and the concept verification of nearly 200 scientific research and clinical cases, of which 4 PCC molecules have started the preparation of IND Package materials, and plans to complete the IND registration applications in China and the United States within 2023. The high-end intelligent manufacturing original research brand "tenon and mortise" nuclear medicine equipment created by Norroy has several commercial models coming off the production line, which urgently needs to be installed in mass production. The business has obtained ISO9001 certification and has successively completed CE and UL certification, and will realize sales revenue in 2023. Norroy Radiopharmaceutical GMP Development Base has been approved by Jiangsu Provincial Department of Ecology and Environment for radiation safety and environmental assessment and has completed its admittance. It is planned to be completed in 2022, and is expected to officially start operation in the first quarter of 2023.
Interview
Q=I·Campus A=Yan Chenglong
Q: Nuclear medicine is recognized as a high threshold field in the industry. What was the reason that Norroy chose to participate in this track?
A: Since 2008, China has not been approved to market innovative nuclear drugs. In the domestic market, only one 18F-FDG has been approved, while the United States has approved more than 20 diagnostic PET tracers. In particular, since 2018, the US FDA has approved the listing of two breakthrough therapeutic nuclear drugs labeled 177Lu respectively, accelerating the layout of international major pharmaceutical enterprises in the field of nuclear medicine, and the development of nuclear medicine has entered an explosive period. It is precisely because of the huge gap between the development of nuclear medicine at home and abroad and the gap in domestic demand for nuclear medicine that we believe that it is urgent to do original research and innovation in nuclear medicine in China, so Norroy Pharmaceutical was established in 2018.
Our team has a long history with nuclear medicine. For example, my graduate project at Jiangda is actually related to nuclear medicine. The founding team of Norroy has been deeply engaged in the field of nuclear medicine for more than ten years. It was the first commercial CRO company in China to use isotope labeling and molecular imaging technology to evaluate traditional innovative drugs, and also participated in the domestic application and implementation of innovative nuclear drugs of international pharmaceutical enterprises. Through cooperation with the Affiliated Hospital of Jiangda and other units, we have also accumulated useful experience in clinical and grass-roots areas. Besides, the participation of such heavyweight experts as Professor Jiang Ji (formerly the director of Phase I Research Office of Clinical Pharmacology Research Center of Peking Union Medical College Hospital) and Dr. Wu Weisi (the first radiologic drug engineer of Merck Pharmaceutical) has made the clinical development and innovative drug research and development of Norroy Pharmaceutical more smooth.
In practice over the years, we have found that nuclear medicine is not only suitable for precise diagnosis and treatment, but also can be used in a wider range of scenarios. For example, combining it with other drugs can achieve the effect of strong combination, which is a very good innovative medical approach. Therefore, many unknowns in this field attract Norroy to continue to explore and make breakthroughs.
Q: What are the difficulties and challenges Norroy has encountered in the process of entrepreneurship? How did you and your team cope?
A: On the one hand, there are financial difficulties. At the beginning of its establishment in 2018, the company was only composed of President Fang Peng and me. We obtained angel round financing in September 2021, so in fact, the first three years were still difficult. But the good news is that the general direction is right, and the efforts made have also passed the test of time and been recognized by the industry.
On the other hand, it is the problem of the experimental site. The so-called high threshold of nuclear drugs, "high" means "high" in the experimental site. First, it is not easy to select the site for radioactive qualification. Second, it will take one or two years to obtain relevant EIA qualification alone. For small scale start-ups, it is really difficult step by step.
Relying on the contacts and resources accumulated over the years in the nuclear medicine industry, we have actively established cooperative relationships with some research institutes and hospitals with radionuclide qualifications. Among them, our earliest cooperative hospital, the nuclear medicine department of the Affiliated Hospital of Jiangnan University, is the first officially established nuclear medicine department in Wuxi with top equipment and laboratories. Their nuclear medicine laboratory hardware facilities are also among the best in the country, and they have Class IV radioactive drug certificates and therapeutic wards of the nuclear medicine department, which are very helpful for our R&D team to do research. Fortunately, the hospital also recognized our research and innovation capabilities. Therefore, the two sides cooperated in the form of a joint laboratory. Since then, Norroy's new drug research and development and clinical transformation have entered the accelerated running mode.
Q: What are the main competitive advantages of Norroy?
A: First, it is to meet the clinical needs. In the early days, we were helping others to evaluate innovative drugs, but now we are doing research and development of innovative drugs. After such a process, our understanding of drugs is very systematic and thorough. At the starting point, we worked closely with oncology and nuclear medicine doctors to directly judge the clinical application scenarios of drugs and products with real clinical value when establishing projects. So we will not blindly follow the trend, but dare to do some new attempts such as non drug targets and First in Class, which are based on clinical value orientation.
Secondly, it comes from the bottom line of technology. Why do we dare to make these innovations? Because we have our own technology platform. On the one hand, based on the rare technology platform of radionuclide labeling and molecular imaging tissue drug generation screening and research and development, it can achieve real-time quantitative tracking of the tissue targeting of drug molecules and obtain drug generation parameters. Through the targeted tissue drug generation model, drug candidate molecules can be screened and modified to ensure the drug success of candidate molecules. In particular, for the "XDC" coupling drug, which is a hot spot in drug research and development, Norroy has built a unique visual "XDC" technology platform, which can realize the radionuclide labeling and in vivo molecular imaging of targeted carrier molecules and toxic molecules respectively, and can realize the research on the drug generation and biological distribution of tumor tissues by visualizing XDC molecules and payloads respectively, This double label in vivo study of XDC also provides a strong material basis for the drug preparation of XDC. On the other hand, rapid clinical proof of concept. In the aspect of drug development, the traditional idea is almost the bench to bedside model, that is, molecular research and development are carried out in the laboratory first, and then animal experiments are carried out. If the experimental results are good, they will enter the preparation and declaration of IND. But in fact, there is a big gap between the results of animal experiments and those of clinical patients, and the clinical success rate is very low. In the process of R&D, Norroy has been able to repeatedly carry out preclinical and clinical experiments, constantly improve drug molecules, greatly improve the success rate of drug R&D in early clinical concept verification, and achieve the "bedside bench bedside" model of efficient verification and low trial and error costs.
The third point is to constantly enrich the talent team. Since last September, we have grown rapidly from a team of only 6 people to nearly 50 people. It is also critical that everyone from different enterprises can continue to play their outstanding professional values in the team of Norroy, integrate with each other and form a joint force. In addition, the blessing of some experts and scholars I mentioned just now has helped Norroy go faster by importing advanced experience and ideas at home and abroad.
Q: Not long ago, Norroy Pharmaceutical launched the GMP nuclear medicine plant construction project, which will be used for the development and production of radioactive drugs and nuclear medicine equipment. Please introduce the business layout of Norroy Medical in the next stage.
A: The business layout of Norroy in the next stage is to accelerate the rapid IND application of innovative drugs and new nuclear drug pipelines and the promotion of formal clinical projects in the next stage, as well as the rapid domestic commercialization layout of nuclear drug equipment.
The first is the innovative nuclear medicine of integrated diagnosis and treatment. In the first half of next year, we plan to carry out the IND Sino US dual reporting of two diagnostic nuclear medicine associations, and the IND reporting of the United States of America for one therapeutic nuclear medicine. The other is our innovative medicine, which is non nuclear medicine. Relying on Norroy's unique visual XDC technology platform and targeted technology advantages of precision medicine, candidate drug molecules of multiple targets have been deployed and verified, and excellent pharmaceutical data have been obtained and PCC molecules have been established. It is planned to launch the application of Sino US IDN in the second half of 2023. The third is the commercialization of automation equipment. From next year, we will start the commercial sales of two types of nuclear medicine equipment, and there are also 2-3 new types of equipment to be released. In addition to the three businesses, we will continue to build and improve technical platforms such as visual XDC and rapid clinical transformation. In the fourth quarter of this year, we launched round A financing and are currently looking for a suitable leading investor. It is planned to be listed on the Science and Technology Innovation Board around 2027 in the future.
Q: How many keywords can you use to summarize the growth and development of Norroy Pharmaceutical?
A: I will choose these two words: clinical value, duty bound.
On the one hand, Norroy will always adhere to the guidance of "clinical value" to develop innovative drugs.
On the other hand, the word "duty bound" is used because we believe that in the field of nuclear medicine in China, although Norroy is still a "new recruit" as a nuclear medicine enterprise, there are not many teams that are more professional or more experienced than us, especially based on Norroy's founding team's familiarity and rich experience in the nuclear medicine industry, so we must stand out and do this. Norroy was born with a sense of mission. We have the responsibility to do a good job in technology, and at the same time, we can help other innovative drug enterprises to contribute to the development of innovative drugs originally developed in China. This is a greater value and goal beyond our short-term commercialization.
Q: Many readers of our official account are from biomedical start-ups and front-line research and development. What experience and suggestions do you want to share with them most?
A: Entrepreneurship in the field of biomedicine, especially in the field of innovative drugs, is characterized by high investment, high risk and long cycle, so the first point is to have clear ideas and positioning. For start-ups and front-line R&D entrepreneurs, it is necessary to clearly position the company and projects, especially in the selection of product positioning, whether it is a copy of fast follow, a micro innovation of best in class, or the original research of first in class. The basis for selection should be combined with their own unique competitive advantages. It is not a random idea, but requires a very solid (project) basis for project establishment, At the same time, we should also use a global perspective to face the future competition of modality drugs with the same indication or different targets. In addition, entrepreneurs need to have a very clear and thorough R&D path and plan for key nodes, as well as a future commercialization path or exit path. For biomedical entrepreneurs, professional teams, project pipelines, technology platforms and continuous financing and other factors need to be considered comprehensively, which require comprehensive ability and clear thinking.
The second point is to clarify the issue of "clinical value" orientation. Whether the drugs or equipment we developed really meet the needs of clinical or users, and whether they can effectively solve problems, is the most fundamental value orientation when setting up a project.
Finally, we hope that start-ups can maintain a cautious and optimistic attitude. Small start-ups are vulnerable. Sometimes a little bit of "butterfly effect" at the macro level may have a great impact on them, and they may not go on. Therefore, many aspects need to be considered in advance, and "thunder" should be avoided as much as possible. For example, the operating cost of Norroy as an innovative drug is very high, so we will support ourselves and ensure research and development by introducing "live water" through the commercialization of automatic equipment and other ways. I believe that Norroy's technology has played a very good role in promoting China's innovative drug development exhibition, and we are also very willing to communicate and cooperate with enterprises in the industry to jointly contribute to the development of China's nuclear medicine industry.
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