Seed Incubator, LinDo K.K.
LinDo is what is known as an incubator, a company that takes the “seeds” of innovative new drugs, grows those seeds, and launches those new drugs onto the market. Its goal is to create an environment that offers the same level of choice of therapeutic drugs as the US and Europe to the frontlines of treatment of rare disorders and intractable diseases in Japan.
In today’s pharmaceutical market, the central focus of drug development is on diseases for which there is a low degree of treatment satisfaction. Drugs aimed at treating rare disorders, intractable diseases, and rare cancers account for the majority of new drug development around the world. Over 70% of the new drugs being created are coming not from the existing pharmaceutical companies, but in emerging biopharma (EBP) companies, which have an extremely high level of drug discovery technology.
Among the new drugs developed by these EBPs, those that are suitable for large-scale manufacture are licensed by the large pharmaceutical companies, which conduct clinical trials in Japan and eventually launch them on the Japanese market. While the EBPs obtain financing to continue their clinical development of the remaining drugs that are not taken up by Big Pharma, it is not easy for them to conduct clinical development in Japan as well as in Europe and the US.
In the pediatric domain, in particular, Japan lags far behind world standards in the development of new drugs
There are three main reasons for this
In general, EBPs’ first priority is to obtain approval in Europe and the US. As such, they do not have the financial wherewithal to undertake clinical development in Japan.
For EBPs, it is not easy to understand the Japanese market, including its structure and potential, and of how to handle Japan’s approval system.
The challenge of corporate networking and partnering for conducting development in Japan remains unresolved.
The compounding of these three reasons has led to the social issue of “drug loss,” in which many new drugs are not developed or approved in Japan, and it is the great hope of patients and healthcare professionals seeking new treatments that they be developed for the Japanese market.
Using a development scheme created in partnership with Medical Incubator Japan K.K. (MIJ), whose people have a wealth of experience working for pharmaceutical companies, LinDo, as seed incubator, will promote the clinical development of innovative new drugs with potential for treating rare disorders and intractable diseases, with the aim of obtaining approval for those drugs in Japan.
Accelerating seed searches and licensing
MIJ is a venture capital firm that has been making private-equity investments in unlisted EBPs globally, including in Japan, since 2018. Its search capabilities extends to several hundred companies a year, from which it selects promising seeds to contact and evaluate.
It leverages the MIJ BG2 Fund to search for more promising seeds.
In addition to its own licensing capabilities, LinDo’s access to promising seeds is bolstered by MIJ’s search and evaluation capabilities, derived from its many and varied global networks.
This tag team of MIJ’s investment and LinDo’s clinical development clears the obstacles preventing EBPs’ new drugs from being developed in the Japanese market, allowing for new drugs that should be licensed in Japan to undergo clinical development at full capacity.
Small, elite clinical development team and lean development management system
To achieve the development and approval of EBPs’ promising new drugs in Japan, LinDo has established a governance structure for compliance with Japanese laws and regulations, and our small, elite team of professionals, who have keen knowledge of and extensive experience in the pharmaceutical business, engage in the entire process, from licensing to development and marketing. We also have a network of partner companies that assist us with everything from development and clinical trials to marketing and logistics.
We partner with a team of highly experienced specialists in the important steps of clinical development, including market searches, identification of hospitals and physicians to participate in the trials, and monitoring. Our development team members, who have a wealth of experience in the development of overseas EBPs’ seeds in Japan, coordinate with the overseas EBPs in devising development strategies, handling pharmaceutical affairs procedures, development management, and even application and approval.
To combat the common problem of delays in patient enrolment in Japanese trials, we leverage the network of physicians maintained by our partner companies to realize the swift identification and early enrolment of patients to suit the trial protocol, something that has been impossible to achieve with existing CROs.
With these new initiatives and our lean management scheme that is unlike those of development companies that have come before us, we will promote the development of drugs to treat rare disorders and intractable diseases.
OUR FOCUS
The domains in which LinDo will focus its licensing and development efforts are “rare disorders” and “intractable diseases (including government-designated intractable diseases)” for which existing therapeutic drugs have been unable to achieve sufficient efficacy or treatment outcomes. In particular, the area of pediatric drugs is one in which there are significant hopes for an improvement in treatment options and expected clinical efficacy, compared with overseas markets.
In Japan, rare disorders are defined as disorders that affect fewer than 50,000 patients in Japan. Because many rare disorders are serious, chronic, progressive, and have a high mortality rate, they have a grave impact on patients, their families, and society.
An intractable disease is defined as a disease that meets the following three criteria according to the Act on Medical Care for Patients with Intractable Diseases:
In Europe and the US, if manufacturing and marketing approval is obtained for indications in adults, development for pediatric indications is mandatory by law, and progress is being made in the construction of various evidence for appropriate drug treatment of children. Because there is no such legal requirement for the development of pediatric drugs in Japan, the construction of evidence for the pediatric application of new drugs and their approval in Japan is lagging further behind.
Progress is being made today in the scientific elucidation of cancers. Through more detailed analysis using the genes and proteins that determine the pathology and course of cancers in individual patients, it is becoming possible to cure diseases or improve the patient’s condition by administering drugs that work directly on individual cancers.
LinDo will focus on drug development that will offer options
for the best treatment methods according to the type of patient.
