Sigenetic Navigates the Future of Large Animal Gene-Editing Models with Confidence Despite Being Just One Year Old

Experimental monkeys, valued at less than 10,000 yuan a few years ago, now have “daily fluctuating prices” and have surged to over 100,000 yuan; laboratory mice and rats, the most frequently used animals in preclinical studies, often cost tens of thousands of yuan. Rising prices and tight supplies have created greater growth potential for the laboratory animal industry.

Once a niche sector, it has now evolved into one of the supporting industries in the life sciences field. Several major players have emerged, among which Model Organisms and GemPharmatech are already listed, while Biocytogen has submitted its listing application to the Hong Kong Stock Exchange.

The laboratory animal industry has finally stepped into the spotlight, but does this mean that its voice in the life sciences field, and even in new drug development, will gradually grow louder?

“Without laboratory animals, the development of many new drugs would be fundamentally unfeasible.“Zhao Jianping, General Manager of Xinuoyin, told VCBeat New Medicine. Leveraging its parent company Sinogene’s technological expertise in animal cloning and gene editing, Xinuoyin, a biotechnology enterprise focused on gene-edited large animal models, is gradually expanding into the broader market for laboratory animals.”

Beijing Xinuoyin Biotechnology Co., Ltd., established just one year ago, has forged in-depth collaborations with numerous academic institutions and new drug development enterprises, including the Institute of Genetics and Developmental Biology of the Chinese Academy of Sciences, Capital Medical University, and Beijing Tongren Hospital. The company has successively developed various gene-edited dog models, such as APOE dogs, and no longer faces revenue concerns.

Mice and rats hold a prominent position in the laboratory animal industry. In China, it has become an imperative path for both industry giants and emerging enterprises to establish their presence in the mouse and rat sector. However, while this sector attracts significant attention, it also faces issues that cannot be overlooked.The success rate of drug screening in mice is no more than 10%, which has led to the low success rate of new drug development.。

A consensus has been reached within the industry:Although mice are currently the most widely used laboratory animals, they can no longer meet the needs of all disease-related research.

Taking neurodegenerative diseases as an example, the most commonly used mouse models differ significantly from human brain structure. Consequently, the vast majority of these models fail to recapitulate the pathological hallmark of typical neuronal cell death observed in patients with neurodegenerative diseases. Furthermore, drugs that show efficacy in murine models of brain disease frequently fail in clinical trials. As mice are no longer the optimal choice for disease modeling, large animals such as dogs and monkeys, which are phylogenetically closer to humans, offer greater advantages in establishing models for major neurodegenerative diseases.

To address this issue, Xinuoyin, which specializes in the development of gene-edited large animal models and leverages the technological expertise of its parent company Sinogene, is well-prepared.

In July 2017, the world’s first gene-edited cloned dog was born in China. At that time, somatic cell cloning technology for dogs was monopolized by South Korean researchers; even the first cloned dog in the United States was successfully bred under the guidance of South Korean scientists. This achievement by Sinogene broke through the technological blockade and monopoly, not only opening up the market in the field of pet cloning but also propelling the company further along its path in developing gene-edited animal models.

Over the past decade, Sinogene has achieved numerous world-first milestones and has successively developed a variety of proprietary disease-model dogs.

When asked why dogs were chosen as the initial step in advancing into the field of large animal models, Zhao Jianping highlighted the advantages of dogs in drug development: Dogs are not only internationally recognized as standard laboratory animals but have also contributed to multiple Nobel Prizes in Physiology or Medicine. Dogs share many similarities with humans in terms of nutritional metabolism and physiological anatomy. From the perspective of genetic diseases, there are over 400 hereditary disorders in dogs that are similar to those in humans.

With the gradual maturation of gene-edited animal model technologies, Beijing Xinuoyin Biotechnology Co., Ltd. was established. It is not a startup built from scratch; rather, it distinguishes itself from Sinogene’s focus on pet cloning by providing comprehensive preclinical CRO services encompassing the development and application of multi-species gene-edited model animals for innovative therapeutics, including gene therapy and cell therapy.

The company has established drug analysis platforms for pharmacology and efficacy, pharmacokinetics and toxicology, and safety evaluation, as well as multi-omics analysis, imaging electrophysiology, and behavioral analysis platforms, striving to make significant advances in multiple therapeutic areas including cardiovascular and cerebrovascular diseases, ophthalmic diseases, metabolic disorders, nervous system diseases, malignant tumors, and rare diseases.

Compared with foreign countries, the development history of laboratory animals in China is not long. The establishment of laboratory animal strains mostly requires introduction and breeding from abroad, and there are currently no fully independently bred large animal model strains.

Taking experimental dogs as an example, domestic enterprises or research institutions initially chose to import breeds from the United States and Japan to meet market supply needs or for their own research purposes. Within the industry, many large-scale research institutions develop and breed disease model animals according to their specific needs; however, no enterprise has yet achieved large-scale industrialization and commercialization of large animal models.

“Among these, technology presents a challenge, but what is even more difficult is the wait and validation over time. ‘In the laboratory animal industry, developing a disease model is only the first step; maintaining a sufficient population size and accumulating data over time to evaluate and validate the stability and maturity of a strain are far more critical,’ Zhao Jianping admitted.”

Today, after years of technological accumulation,Beijing Xinuoyin Biotechnology Co., Ltd. has successfully developed 17 disease models., involving multiple strains including dogs, pigs, cats, rabbits, and mice and rats. Among them,Gene-edited dog models for atherosclerotic disease, autism, GCK diabetes caused by point mutations, and RPE65-associated congenital amaurosis are all world firsts.

In addition to holding unique advantages in canine disease models, the strategy of breeding such a wide range of strains is also part of Xinuoyin’s corporate development strategy. “No single model animal is suitable for all diseases. We have communicated with many principal investigators (PIs), and different diseases require more appropriate model animals,” explained Zhao Jianping in detail. For instance, cats are more suitable for hypertension models due to their relatively stable blood pressure; pigs are suitable for research on heart-related diseases because their heart size and structure are similar to those of humans; and dogs, through long-term convergent evolution during their companionship with humans, are more suitable for research on neurological diseases, tumors, and metabolic disorders.

The construction and breeding of model animals with different strains are the foundation,Xinuoyin aims to build a preclinical CRO platform on this foundation, providing more rigorous and professional services for drug development through the "model organisms + preclinical CRO" development path.Zhao Jianping introduced that, in the process of constructing and developing animal models, Xinuoyin has accumulated research data in various aspects such as molecular identification and phenotypic evaluation. Therefore, Xinuoyin has not only established technical barriers in the development of large animal models but can also extend its advantages by simulating the occurrence and development processes of diseases to help pharmaceutical companies conduct preclinical studies of new drugs.

Currently,Xinuoyin has established four major platforms: a gene-edited model animal platform, a preclinical CRO service platform, an animal production and experimental service platform, and specialized functional laboratories., providing multi-dimensional empowerment across the development and preparation of gene-edited model animals, colony breeding, animal experimentation, early-stage efficacy evaluation of innovative drugs, and preclinical CRO services.

Beijing Xinuoyin Biotechnology Co., Ltd., established just one year ago, has already forged in-depth collaborations with numerous academic institutions and innovative pharmaceutical companies, including the Institute of Genetics and Developmental Biology at the Chinese Academy of Sciences, Capital Medical University, Beijing Tongren Hospital, New Bud Gene, and Zhongji Zhiyao. In the future, Xinuoyin will continue to deepen its cooperation with institutions such as the PLA General Hospital (301 Hospital) and the School of Pharmaceutical Science and Technology at Tianjin University, launching a new round of development of gene-edited large animal models and preclinical drug evaluation studies.

Nowadays, Beijing Xinuoyin Biotechnology Co., Ltd., located in the Daxing Free Trade Innovation Service Center in Beijing, already occupies two buildings totaling 6,300 square meters. Nevertheless, Zhao Jianping has begun to worry that the space will soon become insufficient. He noted that developing more large-animal models is merely the starting point. While establishing collaborations with key research institutions, Xinuoyin aims to further increase its service share for innovative pharmaceutical companies, supporting the development and translation of novel drugs. The company intends not only to extend its reach from Beijing to the Yangtze River Delta and Pearl River Delta regions but also to expand into the international market.