Take the lead in laying out the blue ocean market for malignant pleural effusion treatment.

China is accelerating the approval speed of market access for the treatment technologies for major diseases with clear efficacy and safety.

A few days ago, the Hubei Provincial Medical Insurance Bureau and the Health Commission issued the “Notice on Some Newly Added and Revised Medical Approval of medical service projects. Among them, the medicine-loaded vesicle therapy technology for tumors has also been officially approved for multiple cancer indications, and clinical applications can be carried out in more indications.

This also means that the application market and population expansion of China’s first drug-loaded vesicle treatment technology for tumors will benefit more patients.

A new therapy with both immunotherapy and biological chemotherapy characteristics?

Drug-loaded tumor microparticle immunotherapeutics(drug-loaded tumor microparticle immunotherapeutics, hereinafter referred to as “DTMI technology”) is a new tumor biological immunotherapy biotechnology platform based on extracellular vesicles (EVs).

It is based on extracellular vesicles of natural biological origin with diameters between 100-1000 nanometers, and is combined with the delivered drug molecules or biologically active substances. Form a brand-new drug delivery and controlled release model, form drug-loaded vesicles with multiple anti-tumor functions, and achieve the purpose of treating tumors by mobilizing the largest number of neutrophils known as the human body’s natural barrier. >A new tumor immunotherapy with the characteristics of both immunotherapy and biological chemotherapy.

The approved DTMI technology was developed by Hubei ShengQi’an Biotechnology Co., Ltd. (Soundny-bio, 870592, NEEQ) independently researched and developed the initiative and has a global patent system.

According to the introduction, different from other immunotherapies, DTMI technology uses the characteristics of vesicles to transmit information between cells, and through biophysical mechanism of action, it is easier to target and kill tumor stem cells that cause tumor recurrence and metastasis, while activating Immunity, remodeling the tumor immune microenvironment, has the characteristics of low toxicity and high efficiency.

As of now, Shengqian Biology has carried out clinical cooperation with more than 60 mainstream tertiary hospitals across the country. Currently, the marketed indications include malignant pleural effusion and cholangiocarcinoma. The upcoming indications include lung cancer, gastric cancer, liver cancer, esophageal cancer, and malignant abdominal cavity. Effusion etc.

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Laying out a blue ocean market for malignant pleural effusion treatment

It is worth noting that malignant pleural effusion is the first to be used in the indications that have been on the market. This market is regarded as a blue ocean market by the industry.

This is because many solid tumors such as lung cancer, breast cancer, and ovarian cancer can metastasize to the pleural cavity and form malignant pleural effusion. Taking lung cancer as an example, up to 60% of patients with advanced lung cancer will have malignant pleural effusion, which seriously affects the patient’s life cycle and quality of life. However, there is a lack of effective clinical treatments.

A “Pleural Effusion Treatment Market Analysis Report” published by Hengzhou Bozhi Information Consulting shows that in recent years, the global pleural effusion treatment market has developed Fast, among them, the global revenue in 2018 was close to US$4.23 billion, and in 2019 it was US$4.482 billion. The average market growth rate was 5.91%, and the compound annual growth rate for 2020-2026 is expected to be 6.60%.

However, currently, there is no universal gold standard for the treatment of malignant pleural effusion in China, and most of the existing treatment methods are symptomatic and palliative treatment.

The results of a number of clinical studies in the early stage of DTMI technology show that it has shown good effectiveness and safety. Compared with the traditional malignant pleural effusion treatment, the remission rate is about 50%, and the remission rate of DTMI technology is 30 higher. %about.

At present, many studies have been carried out on the treatment of diseases with extracellular vesicles represented by DTMI technology on a global scale. A set of EVs statistics based on PubMed search shows that since 2010, the global academic achievements on EVs have increased exponentially every year.

In the capital market, well-known domestic and foreign institutions, including Tencent and IIIumina, have deployed the extracellular vesicle field in advance, and the latter has become a blue ocean market that investment institutions are eagerly chasing. It is worth noting that the clinical transformation of these projects has mostly developed to the pre-clinical and clinical phase 1 stages, which is quite different from the development progress of Shengqi’an Biological.

11 years of long research and development

I learned that aboutThe research and development of DTMI technology can be traced back to 2009, Sheng Qi’an Biological research and developmentThe team started at that timeDrug-loaded vesicles in tumor treatment The research by encapsulating chemotherapy drugs in vesicles released by tumor cells proved that drug-loaded vesicles can kill tumor cells efficiently. This work was published in Nature Communications in 2012.

Next, the team further confirmed that drug-loaded vesicles preferentially kill drug-resistant tumor seed cells. The relevant results were published in “Cell Research”, “Biomaterials” and other journals . At that time, there were relatively few basic researches on extracellular vesicles in the world.

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After more than ten years of research, the R&D team has successively clarified the organic combination of vesicles with chemotherapy drugs, oncolytic viruses, and biological macromolecules to form rich Application scenarios, and continue to study the technology’s killing and action mechanisms on tumor cells, so that basic research and clinical experts continue to optimize clinical treatment plans.

In the future clinical application of the technology, Meng Fanfan, President of Shengqi’an Biotech, pointed out that the technology has a broad spectrum of indications, which can be combined with chemotherapy drugs and viruses. , Can also do vaccine-related research, “Its indication is not only in the field of tumors, we position it as a biotechnology platform with a wide range of application scenarios.”

“New medical technology model” completes clinical transformation

It is worth mentioning that, unlike the innovative therapies that are generally approved for marketing through NMPA, DTMI technology adopts a more “special” “new medical technology model” Completed the clinical transformation.

Specifically, the new medical technology model is for companies to sign medical technology service contracts with hospitals, and the hospitals carry out clinical applications, which is in line with the current and future directions and trends of China’s deepening reform of the medical and health system.

Reflected in the company’s clinical transformation, as of now, the technology has been approved for use in the 7 provinces and cities of Anhui, Hubei, Hunan, Hebei, Tianjin, Shandong, and Shenzhen. One of the new medical technology companies for disease research and clinical transformation.

According to Ma Gang, the director and vice president of Sheng Qi’an Bio, In the second half of 2019, this technology realized the first fee collection in Anhui, forming a closed-loop business model; The technology obtained Hubei Province price approval, and obtained the clinical application ethics approval of Wuhan Union Hospital, based on itsThe huge number of patients will also be the company’s recent sales focus.

also understand thatShengqi’an Biotech has been listed on the New Third Board in February 2017 . Based on the industry in which Sheng Qi’an Biology is located and its strong technological innovation attributes,Meng Fanfan revealed that At present, many institutions and host brokerages are actively seeking cooperation. The company will consider the pace of development of the company and launch the SSE STAR Market at an appropriate time.