Qihan Bio Secures Over RMB 100 Million in Pre-B Funding and Advances First Product QN-019a into Clinical Trials

Nov 06, 2023 10:55 CST Updated 10:55

Qihan Biotech

Gene Editing Technology Developer

HongShan

Business Consulting, Enterprise Management Consulting Investment Institutions

Lilly Asia Ventures

Biopharmaceutical Investment Management Institution

▎WuXi AppTec Content Team Report

Recently, the biopharmaceutical company Hangzhou Qihan Biotech Co., Ltd. has achieved many significant developments: on July 18,The approval of QN-019a, the first product of Hangzhou Qihan Biotech Co., Ltd. for clinical trial in China, marks the company's official entry into the clinical stage.On September 13, Fortune announced the list of "China's Most Socially Influential Startups" for 2023.Hangzhou Qihan Biotech Co., Ltd. successfully made the list with its innovative technology in the field of cell therapy.; September 22,QihanHangzhou Qihan Biotech Co., Ltd. Announces Completion of Over 100 Million Yuan in Pre-B Round Financing, to support the rapid iteration and global development of the company's gene-editing products over the next 4-5 years. These developments have once again drawn industry attention to this rising star.

Hangzhou Qihan Biotech Co., Ltd. was founded in 2017.Dedicated to applying high-throughput gene editing technology in the fields of cell therapy and organ transplantationHangzhou Qihan Biotech Co., Ltd. was named one of the "50 Smartest Companies of 2019" by MIT Technology Review. Since its establishment, Qihan Biotech has received support from numerous investment institutions such as Sequoia Capital China, CMB International Capital, Lilly Asia Ventures, Matrix Partners China, and Zhejiang Industrial Fund. The company has built a high-throughput gene-editing platform, a stem cell differentiation immune cell platform, and a non-human primate platform, which can be used to develop various universal products. Currently, Qihan Biotech...YesMultiple allogeneic cell therapy products have been advanced into investigator-initiated clinical trials (IIT)., among whichGene-Edited iPSC-Derived Cell Therapy Product QN-019aHas obtained the clinical trial implied permission from the National Medical Products Administration of China.

So, what are the core advantages of Hangzhou Qihan Biotech Co., Ltd. in the field of cell and organ therapy? What are the key challenges for cell therapy transitioning from individualized treatments to off-the-shelf solutions? What potential solutions does Hangzhou Qihan Biotech Co., Ltd. offer for these challenges? With these questions in mind, the content team of WuXi AppTec recently conducted an exclusive interview withDr. Luhan Yang, Founder and Chief Executive Officer (CEO) of Hangzhou Qihan Biotech Co., Ltd.Dr. Yang received his bachelor's degree from Peking University and his Ph.D. from Harvard University. He has been repeatedly featured in various elite lists published by renowned magazines such as Forbes and Fortune.

Image Source: Provided by Qihan Biotech, Produced by the WuXi AppTec Content Team

WuXi AppTec Content Team: Why did you choose to start a business in the field of cell and organ therapy?

Dr. Luhan Yang: A review of the entire history of pharmaceutical development, from small molecules to large molecules, shows that drug development has increasingly tended toward targeting and functional diversity. Distinct from small molecules and large molecules,Cell therapy is a living drugIt not only possesses cytotoxic and expansion capabilities, but also attracts other immune cells to attack tumors after expansion, offering more diverse and sustained functionality. Additionally, cell therapy can serve various structural functions. Therefore,I believe that cell therapy will definitely be a trend in the future of drug development.。

Organ transplantation is another field that I am optimistic about. I once read a book that had a profound impact on me, called *The Puzzle People*, written by Dr. Thomas Starzl, the founding figure of the organ transplantation field. This book made me realize,Organ transplantation can save critically ill patients and enable them to survive for 30 to 40 years post-transplant, which is a remarkable achievement in the fields of biopharmaceuticals and life sciences.。

I myself majored in biotechnology, and have been working in the cell and organ therapy industry since graduation, for nearly 8 years now. I feel extremely fortunate to have caught the right era, learned and mastered advanced technologies and tools, and been lucky enough to participate in and witness the rise of the cell and gene therapy (CGT) industry.

WuXi AppTec Content Team: What are the unique advantages of Hangzhou Qihan Biotech Co., Ltd.'s technology and products? Which pain points in current disease treatment do they have the potential to address? What are the key challenges to fully realizing the potential of Qihan Biotech’s cell therapy products? And what are the potential solutions?

Dr. Luhan Yang: The mission of Hangzhou Qihan Biotech Co., Ltd. is to leverage its strengths, namely the use of multi-gene editing technology and understanding of transplant rejection, to developOff-the-shelf allogeneic cellsAndXenogeneic Organ Therapy, ultimately alleviating patient suffering. Our short-term goal is to develop off-the-shelf cells, while our long-term vision is aimed at organ therapy, which requires long-term accumulation.

Off-the-shelf cells hold great potential, especially those derived from stem cell sources. The field as a whole is still in the early stages of industrial exploration, primarily due to two fundamental biological issues that remain unresolved.First, if the source is allogeneic cells, it will inevitably face host rejection, thus challenging the sustainability of the cells.. In this context, how to design and optimize the product to rapidly kill tumors like autologous cells while enabling long-term monitoring of tumor recurrence is an urgent issue for the industry to address.Secondly, if the source is stem cells, how can we make the differentiated cells match primary cells in terms of safety, efficacy, and long-term persistence?，Is also a considerable challenge.。

At Hangzhou Qihan Biotech Co., Ltd., we have established several technical platforms that are expected to address the core issues in this field.1. High-throughput gene editing platformIt can modify dozens of genes on a single cell, which is especially necessary when product assembly is complex and multiple factors such as anti-rejection response, sustainability, and killing function need to be considered. Multi-gene editing is essential in these cases and can also help accelerate product development.Second, a non-human primate platform that is mirror-symmetrical to humansThrough this platform, we can reprogram monkeys' fibroblast stem cells into stem cells, then differentiate them into immune cells and infuse them back into the monkey's body. This is different from the xenogeneic models used by most cell therapy companies that conduct preclinical animal experiments on mice. The non-human primate platform can better simulate the human immune system, providing solid animal data support for testing the clinical safety, persistence, and efficacy of gene-edited NK cells. It also gives us more confidence in the product before it enters clinical trials. For example, we can inject multiple differently edited cells into the same monkey and then screen which edits are beneficial. We can also perform PET-CT scans and in vivo tests on the monkeys to better understand the distribution, homing, and survival of the cells in the body.Moreover, thanks to China's dual-track system for cell therapy products, Hangzhou Qihan Biotech Co., Ltd. can also rapidly iterate its products., under the supervision and cooperation of health departments and hospitals, clinical trials are carried out.

Of course, in my opinion, for a company,Technology is the cornerstone, but the key to a company's success lies in its people and culture.In the past few years, Hangzhou Qihan Biotech Co., Ltd. has formed several very distinct cultures that help the company address R&D challenges in the field of cell therapy.We are a hard-fighting team.. Although the scientific research we are engaged in is challenging, if we consider it from the perspective of first principles, the two fundamental issues of cell therapy are solvable scientific problems. What we need to do is figure out how to solve them. Meanwhile,We are also an open and self-reflective team.After all, our understanding of diseases, cells, and even tools is limited, and the entire field is still in the early stages of exploration while learning and doing. Therefore, the team at Hangzhou Qihan Biotech Co., Ltd. is constantly acquiring new skills, knowledge, and work methods every day to make progress together.Unity and cooperation are also one of our core cultures.Because the product needs to achieve rapid iteration from research and development, production to clinical application, it not only requires fast transformation from upstream to downstream, but also needs downstream to quickly feedback critical information to upstream. The cooperation and tacit understanding of the team in this process are very crucial.Qihan Biotech starts with technology, and if one day we succeed, I believe it’s because of our people and culture.。

WuXi AppTec Content Team: In the next few years, what milestone developments are expected in Qihan Biotech's R&D pipeline?

Dr. Luhan Yang：QN-019a is an immune cell product that combines gene editing with stem cells., whose clinical trial application has received the tacit approval for clinical trials from the China National Medical Products Administration,We will steadily advance its clinical trials for B-cell lymphoma.。

At the same time, we are alsoDevelopment of iPSC-derived off-the-shelf products for acute myeloid leukemia (AML)，Hope to achieve 50% complete response (CR) and long-term sustained remission in the study, thereby benefiting patients. AML is a hematological tumor with significant unmet clinical needs. Patients who are intolerant to radiotherapy and chemotherapy or experience recurrence have an average survival of only about six months. CAR-T therapy also has limitations in terms of safety and efficacy in treating AML. Immune cells derived from iPSCs, especially NK cells, offer certain advantages in AML treatment, which is also a key area our rapid iteration platform needs to breakthrough.

In addition,We will also explore the application of other iPSC-derived immune cell products in other disease types.。

WuXi AppTec Content Team: If we gather here again 10 years from now, what changes do you think the cell and gene therapy field will witness? Could you paint a picture of what the landscape might look like in 10 years?

Dr. Luhan Yang: I am cautiously optimistic about this. According to the innovation curve proposed by Gartner, a globally renowned technology consulting firm, all innovative technologies go through stages of rapid growth, sharp decline, and eventual recovery. When a new technology emerges, everyone rushes to embrace it; when it is discovered that the technology cannot be successfully implemented, people begin to panic and withdraw, which is a process of disillusionment; as the technology gradually matures, it enters a slow upward phase of enlightenment; finally, the technology achieves mature development and widespread application. In fact, all technologies in various industries, including TMT (telecom, media, and technology), biopharmaceuticals, chips, artificial intelligence, etc., follow this curve, although the cycles, peaks, and troughs may vary for different technologies.

In my view, the current现货-type cell therapy is still in a stage of bubble disillusionment. ButLooking Ahead to the Next Decade，I believe there will definitely be companies that can develop off-the-shelf cell therapy products, and among them will be Chinese companies.. Meanwhile,The indications for cell therapy will be greatly expanded, not only for hematological tumors, but also for solid tumors, autoimmune diseases, infectious diseases, and even anti-aging. This is also an inevitable trend.Hopefully, in the future, whatever immune cells can do, cell therapy will be able to do as well.

WuXi AppTec Content Team: As an entrepreneur in the innovative drug field, what other viewpoints and voices do you hope to convey to the industry?

Dr. Luhan Yang: The development of off-the-shelf cell therapy products is a long and challenging journey, but progress is possible with persistent effort. This field is currently facing numerous difficulties: scientific uncertainties, an industry capital winter, and challenges in recruiting, training, and retaining talent. However, imagine 10 years from now—if we can truly transform innovative technologies into products that benefit patients, it will not only reshape the entire pharmaceutical landscape but may even influence the way new drugs are developed globally. If all this can be achieved, every effort and sacrifice will have been worthwhile. I also hope more like-minded individuals who wish to contribute to the biopharmaceutical field will join Hangzhou Qihan Biotech Co., Ltd., to create value together and change the future.

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