Kang Ai Biology: committed to the DC-T solid tumor immunotherapy new drug, preparation of Pre-IND, planning industrialization landing

Guide: Kang ai bioimmune treatment program to promoteThe National Cancer Center's cancer statistics released in 2019, noted that "in 2015 there were about 3.929 million cases of malignant tumors and about 2.338 million deaths." On average, more than 10,000 people are diagnosed with cancer every day, and 7.5 people are diagnosed with cancer every minute"Furthermore, in the past 10 years, the incidence of malignant tumors in China has maintained an annual increase of about 3.9%, and the mortality rate has maintained an annual increase of 2.5%with the succession of legendary creatures and Shenzhou cells, the domestic cell immunotherapy industry in 2020 ushered in a wave of small climaxBeijing Kang Ai-Hao Biotech Co., Ltd(hereinafter referred to as Kang Ai Biological) is one such company engaged in the development of tumor cell immunotherapy products, using innovative technology to provide cancer patients with high-quality, high-accessible treatment programsSource: Lanzhou Institute of Biological Products teamKang Ai Biology team, and Lanzhou biological products research all certain sourcesDrLu Wei, founder of Kang Ai Biology, has his own doctoral degreeFor eight years since 1996, DrLu has been a researcher at the Lanzhou Institute of Biological ProductsIn 2004, DrLu came out with a group of like-minded friends and began researching cell therapyToday's Kang ai biology, some of the technical backbone is at that time Lanzhou Institute of Biological Products personnelactually, there have been some episodes in betweenDr Lu entered the company that was related to Huada's genes In 2008, he briefly joined Beijing Huada Jibi Ai Biotechnology Co., Ltd., and in 2010, Dr Lu Wei was the Marketing Director of the Medical Health Division Of Huada Gene Research Center Co., Ltd in Beijing For Dr Lu, this experience has brought about an accumulation of market experience But since then the two sides are not much contact, Huada Gene more focus on front-end diagnosis, Kang Ai biological to try anti-cancer drug research and development treatment 2012, Kang Ai Bio was finally announced Li Junyang, deputy general manager of Kangai Biology, said in an interview that Dr Lu's original specialty was to study the field of cells, and the current technology patents used are more of the results of Dr Lu's study The research team from the Lanzhou Institute of Biological Products is not limited to technical research for Kang Ai Biology Team members also have production processes involved and are familiar with the entire production process And this is very helpful to the product industrialization of kangai bio in the near future line: to MTCA-CTL products as the core, preparation of Pre-IND Li Junyang said in an interview, although the car-T productCD19, CD20 is also continuing research and development, but the focus on MTCA-CTL products MTCA-CTL products are in preparation for Pre-IND (communication meetings with the review center prior to the declaration of clinical approvals) The product in the last year has ended animal experiments, efficacy, rapid poison have been completed The product clinical trial targets patients with advanced stomach cancer There are also plans to expand dozens of indications in the future There are plans to maintain concentration in the treatment of advanced stomach cancer MTCA-CTL is a kind of autoimmune cell therapy technology, the main feature is to ensure that non-MHC (main tissue compatibility complex, human MHC is called HLA) restrictive lethal NK-T cell amplification at the same time, directed amplification of MHC restrictive CD8-specific CTL cells When amplification, autologous dendritic cells treated with a variety of tumor antigens are added to co-culture, stimulating induced immune cells, enabling them to specifically identify and kill tumor cells the "KACM001 injection" in the 2019 financial results is actually the company's MTCA-CTL product Kang said the product will be priced at 3-50,000 yuan per course In fact, immunocellular therapy is the use of the patient's own immune cells for treatment, in addition to minor fever side effects, the patient has little burden in terms of clinical effect, The Chinese Academy of Medical Sciences Oncology Hospital released a new generation of cell immunotherapy MTCA-CTL joint chemotherapy treatment gastric cancer phase II clinical research data show that compared with chemotherapy groups, the combination treatment of non-removable gastric cancer median progression survival extended by 135 days, median survival extended by 206 days MTCA-CTL technology as a new generation of cell immunotherapy technology, compared with the previous two generations of DC-CIK as the representative of nonspecific cell immunotherapy and DC-CIK-specific immunotherapy, the immunotherapy added a variety of specific antigens, with more accurate target tumor killing effect, and can produce immune memory other: medical testing brings cash flow, CAR-T, stem cell product balanced development put the importance of MTCA-CTL products before CAR-T products, is based on reality considerations At present, due to the heat in this field, 90% of enterprises are currently laying out CAR-T products Due to the influx of CAR-T products into the declaration, the filing process is longer and cannot be approved quickly more realistic considerations may come from the market CAR-T products are more cut into the field of hematoma, but the patient base is small market space is not large Two CAR-T products, which have been approved abroad, sold for $475,000 and $375,000, respectively Such expensive unit prices also make it impossible for patients to afford it Clinically, cytokine storms, neurotoxicity and other reactions may also occur Technically, these issues have yet to be addressed In addition, Li Junyang said, "CAR-T products, although up to 80% of the remission rate, but the recurrence rate of up to 50%." After off-target and then use THE CAR-T product, the larger case is invalid." Enterprises want to CD19, CD20, CD22, CD138 and other targets, to find CAR-T products other targets, it is difficult Kang ai Biology is currently working with the Fourth Military Medical University and the Chinese Academy of Medical Sciences Oncology Hospital, but also with more than 30 other hospitals across the country to cooperate, covering all parts of the country At present, the hospitals that cooperate with Kang Ai Biology in clinical practice include the Chinese Academy of Medical Sciences Oncology Hospital, Lu Daopei Hospital, Gansu Provincial People's Hospital, Gansu Cancer Hospital, Landa Hospital and so on Kang Ai Biological plans to conduct clinical multi-center recruitment at the co-operative hospital after receiving the approval in fact, in addition to MTCA-CTL products, Kangai Bio is currently balancing the development of CAR-T products (CD19, CD20) and stem cell products CAR-T products have been tested in human sand, with a good rate of mitigation In terms of stem cells, two drugs are being developed using interstitial stem cells, one for bone joints and one for type 2 diabetes There is also a partially small stem cell storage business that comes with it bring cash flow to the enterprise is its immune testing of the medical examination The Medical Examiner has reached some cooperation with the Sanjia Hospital and the commercial medical examination institutions Prior to the development of new drugs, which were primarily used to keep cash flow running, Kang ai Bio had the ability to make its own blood compared to other companies that had fallen due to large environmental impacts the future: looking for an industrial base to realize the listing Kang ai creatures have a fairly clear understanding of their own advantages They realized the importance of sales channels to the business Even if there are good medicines, whether they can be developed, channels are also a very important part Prior to the cooperation of more than 30 hospitals, will be well supported by the future industrialization of Kangai biological, convenient for its rapid opening of the market Medical inspection business currently provides cash flow at the same time, the realization of the diversion, to help Kang Ai biological product evaluation standards set Third-party medical examination marketing team can also help MTCA-CTL products in the future to achieve rapid marketing promotion for the health of the creature, safety and effectiveness are always the first If a drug is on the market, cost-effective enough, and safe enough, it will be a better drug After ensuring safety, effectiveness, and cost-effectiveness, it also means a broad market space for an enterprise at present, Kang ai bio more hope to engage with local governments, looking for a base to achieve industrialization, and in the process of landing to seek the support of industrial funds In fact, this is also for the new drug to get the batch, and do the preparatory Kang said that most of the company's products may stay in the laboratory stage, do not have the ability to industrialize, but Kang ai Bio believes that its technical team, because of familiarwith with the process, so do not need to worry too much Kang ai biological goal is very clear, is to rush to industrialization actually, there is also capital in the contact with Kang Ai creatures, hoping to enter before the IND For the capital market, Li Junyang believes that into the cell therapy enterprise's capital harvest period At the moment, HKEx biopharmaceutical companies only need to meet a $1.5 billion valuation and can go public without revenue Co-tron board also provides a certain convenience for biopharmaceutical enterprises Biopharmaceutical enterprises need a lot of capital investment in the early stage, but in the later stage basically no more capital, for the capital is good Kang ai bio is optimistic about the capital market registration system reform, the future at the right time will also consider the Sprint Branch board or GEM