And Huang Medicine Su comfort country: based on China synchronization of global high-quality drug innovation steady...

On January 23, 2021, and Huang Pharmaceutical's innovative oncology drug Sutaida ® (Sovantini capsules) was launched in Beijing, Shanghai and Guangzhou in a "offline plus online" linkage, while the "Suda Newborn Patient Assistance Project" around Sovantini was officially launched.
, a member of the Chinese Academy of Sciences, first affirmed the listing of Sovantini, "Sovantini's arrival fills the clinical gap in the treatment of non-pancreatic neuroendocrine tumors in China."
and proved to the global medical community the strength of China's innovative medicines.
" Sovantini is the second innovative oncology drug approved for listing in China, following the approval of the market, and Huang Medicine has opened up more commercial possibilities for Huang Medicine.
such a significant milestone, Sovantini's progress has not stopped.
is understood to have begun rolling applications for Sovantini's first overseas drug listing to the FDA, and plans to submit Sovantini's listing license application in Europe, as well as launching Sovantini's development and commercialization programs in China, the United States and around the world.
From the project in 2006 to the end of 2020 was officially approved, Sovantini's research and development has gone through 14 years, 14 years of hard work, 14 years of hard work, 14 years of global steps, and now a new journey, what is the unforgettable story behind Sovantini's research and development? How will patients better enjoy this innovation? What are the difficulties and challenges of Huang Medicine's long-held path of innovation? How will the globalization and capitalization strategy of Huang Medicine go in the future? ...... To further explore the answers to the above questions, Sina Pharmaceuticals interviewed Mr. Su Sooguo, Chief Scientific Officer of Huang Pharmaceuticals.
Explied frontier blue wisp" Sovantini's listing road, can be said to be a road we completely walk out on our own, is a road to break the frontier, road blue wisp road.
" - If China's innovative pharmaceutical industry today is thriving under policy dividends and capital, Sovantini's project was a barren scene at the beginning of 2006.
that time, and Huang medicine needs to face the test of the unknown, can only constantly touch the stone across the river.
In 2008, shortly after Sovantini's project began, he was hit by the global financial crisis, and Huang Pharma, like all start-ups, faced extremely difficult financing problems, according to Mr. Su.
, however, the financial difficulties are by no way the only difficulties to face in the development of new drugs, and the difficulties of technology are more related to the life and death of the entire project.
most memorable thing about the Soviets was that Sovantini had been suspended for a year for technical problems.
problems occurred in Theofantinist into Phase I clinical studies, where oral absorption was uneven due to drug solubility.
, the drug exposure is too low, the efficacy is not guaranteed, and the exposure is too high to lead to adverse reactions to the drug.
the same dose or so must have a more uniform absorption, so that the amount of drug exposure in the body in a reasonable range, can effectively guarantee efficacy, without leading to more serious adverse reactions.
the problem, and Huang Medicine immediately called off the clinical trial of Sovantini.
and then spent nearly a year re-researching and optimizing Sovantini's preparation process before restarting clinical studies.
more than a year of improving the preparation process, in order to adhere to the original, the Soviet comfort country and the research team like standing on the edge of the cliff to rescue the project, under enormous pressure.
"We did not give up, completely on their own to support it, adhere to the preparation optimization to overcome the drug solubility, and ultimately proved to be right," suzuzied.
addition, Sovantini faces a very long clinical trial because non-pancreatic neuroendocrine tumors are relatively "rare" tumors and have a relatively small number of patients.
good in this one soaked in the sweat of the struggle of the study, finally blossomed.
the first heart not to benefit patients" as a domestic innovative drug, we do not want to see patients for economic reasons do not use our innovation results.
" - On December 30, 2020, Sovantini was officially approved by the State Drug Administration for the treatment of non-pancreatic neuroendocrine tumors.
Sovantini is a new type of oral tyrosine kinase inhibitor with dual anti-tumor mechanism, including inhibition of tumor angiogenesic, but also can regulate tumor microenvironmental immune response, activate the body's immune function.
data show that in 2018, there were about 67,600 newly diagnosed cases of neuroendocrine tumors in China, and according to the ratio of incidence to prevalence in China, there are a total of 300,000 neuroendocrine tumor patients in China, of which about 90% are non-pancreatic neuroendocrine tumors.
In the huge demand of patients, the domestic neuroendocrine tumor targeted drugs have been limited, and the efficacy and tolerance need to be improved, the advent of Sovantini for patients to bring new hope, but to truly benefit patients, the patient's financial burden is also a necessary consideration.
, Mr Su said: "Any commercial company needs to be profitable to support subsequent research investment in order to achieve sustainable development."
For and Yellow Medicine, whether it's pyridoquine or Sovantini, these original and innovative drugs, which are rooted in China, will always adhere to the concept of maximum patient accessibility and affordability as a commercialization.
"We don't want to see patients not being able to use our medicines for economic reasons, and I want our innovations to benefit patients as much as possible," Su stressed repeatedly.
, in order to improve drug access, and Huang Medicine has now built 400 people of professional oncology academic promotion team.
, china has also reached strategic cooperation with the National Pharmaceutical Group, covering 30 provinces, municipalities directly under the Central Government, more than 2000 hospitals.
And in order to enable more non-pancreatic neuroendocrine tumor patients to "use" and "affordable" domestic innovative drugs, and Huang Pharmaceuticals also joined hands with the China Primary Health Care Foundation launched the "Suda Newborn Patient Assistance Project", and Huang Pharmaceutical will provide the project free of charge Sovantini, by the China Primary Health Care Foundation responsible for project management, supervision, audit and implementation.
same time, The Soviets said Sovantini would participate in health-care negotiations this year in 2021, when more patients are expected to get Sovantini in a more cost-effective way.
addition, and Yellow Medicine has begun to develop more adaptations to Sovantini, to explore the therapeutic efficacy of Sovantini in areas other than neuroendocrine tumors for the benefit of more patients.
"Independent innovation is a difficult risk path, and the reason why Huang medicine can persist is in the beginning, we hope that through independent innovation to bring hope to patients, to bring patients more and better treatment options, but also hope that they can afford this medicine."
"To overcome the stubborn disease who" and Huang medicine's innovation path and China's innovative pharmaceutical career development trajectory, is a from nothing, from zero to one, from one to more process.
" - Su comfort country and Huang medicine was founded in Shanghai Zhangjiang in 2002, the establishment of the beginning of the firm to take the road of independent research and development.
was a very ambitious goal in China's innovation and research and development environment at the time, but also a very risky and costly thing.
no doubt, and Huang medicine took a rare road, there is a "give me who, overcome the disease" spirit.
hard-working people, after years of persistence, and Huang medicine has now forward-looking layout of a number of research pipelines, and began to enter the harvest period.
At present, and the yellow medicine pyridoxine, Sovantinib has formed a two-star layout, and another new drug Sevotinib is also on the rise, Sevotini is expected to become the first on behalf of China to the global lung cancer targeted innovative drugs, and Yellow Medicine to open the "three swordsman" to fight the global cancer market situation.
addition, according to Su comfort country introduced: "Currently and Yellow Medicine has 9 clinical stages of products, by 2022 should have 13 products into clinical research."
addition, not only the number of products, but also the trend of geometric growth in clinical studies per product, in the case of Sovantini, we may start 12-15 different clinical studies this year.
" and Yellow Pharmaceutical Pipeline, October 1, 2020 update (official website information) to expand the world in the same boat" and Huang Medicine has always adhered to two major principles, one is independent innovation, the other is global synchronization.
" - In recent years, the new domestic drug "out to sea" has become an increasingly important strategy for pharmaceutical companies, and Huang medicine is undoubtedly the "explorer" in this group of enterprises.
the secret of going to sea is to turn off good quality! Su said that And Huang medicine has always adhered to two major principles, one is independent innovation, the other is global synchronization.
almost all products adopt a strategy of simultaneous global development.
are mainly reflected in - 1, all candidate drugs are self-developed and have global registration potential.
2, take Sovantini as an example, in the research design, the choice of the main endpoint, etc. are in accordance with the highest standards of international clinical research.
quality of clinical research in Sofantini at present has been well received at home and abroad.
Susazu Added:
The positioning of He Huang Pharmaceuticals hopes to bring China's innovative talents and innovation forces to the international stage, to create international-level innovation results, and ultimately to serve patients around the world."
is understood to have filed a rolling application for Theovantinib's listing with the FDA at the end of December 2020, following the FDA granting Sovantini two fast-track qualifications in April 2020 and orphan drugs in November 2019.
, Sovantini is planning to submit a listing permit application to the European EMA.
in September 2020, the third phase of the global study on pyriquine has also been launched.
addition, in 2020, Severtini's China listing application has been submitted, is expected to be approved for listing in mid-2021.
several clinical trials are under way around the world during the same period.
...... It is worth mentioning that in order to further global research and development, and Huang Pharmaceutical's previously suspended IPO plans are also considering a re-agenda.
s more and more products are being commercialized, this will help boost investor confidence in us, and an IPO may be a better time," said Mr Su.
and Huang Pharma, a Chinese innovative pharmaceutical company headquartered in Hong Kong, China, and most of our operations are in Chinese mainland, so we have been actively considering a return to the local market listing, the future hong Kong or mainland market may be the choice.
" can be seen, from the beginning of its inception, and Huang medicine adhere to the "independent innovation", "globalization" this rare and very difficult road.
road, once fraught with thorns, is becoming a brighter highway in the face of international integration, policy dividends and capital holdings.
and Huang Medicine, one of the earliest pioneers of innovative drugs in China, are now entering a state of continuous development in the field of diseases such as cancer and autoimmunity around the world, and it remains to be seen how it will hold the bull's ear in the future.