Scientific And Technological Innovation Enterprises Visit Series Report Part 1: Finding A New Way To Speed Up The Research And Development Of "Epidemic" New Drugs

"The clinical trial of Prochloraz in patients with severe new crown has been approved by the Brazilian independent review board (IRB)"

Behind the enterprise announcement on January 28, it is to further develop the pharmaceutical industry as a pioneer in anti epidemic.

Prochloraz is independently developed by the pioneer pharmaceutical company headquartered in Suzhou Industrial Park. The preliminary results of clinical trials showed that prochloraz had prominent effect and good safety in the treatment of mild and moderate covid-19 patients, and it was positive for both male and female patients.

"We plan to promote phase III international multicenter drug clinical trial (MRCT) as soon as possible, apply for emergency medication license, and let more new crown patients benefit from prochloraz treatment as soon as possible," said Dr. Tong Youzhi, founder, chairman and CEO of pioneer pharmaceutical

Over the past two months, the shares of pioneer pharmaceutical have risen more than 50%.

For the capital market, the important progress of pharmaceutical industry development in 2020 also includes: IPO listing in Hong Kong, key layout of small and medium-sized molecules, and operation of R & D centers and production bases.

The interview of the 21st century economic report on the development of pharmaceutical industry was conducted at No. 20, Songbei Road, Suzhou Industrial Park, where the GMP factory is located.

The production base, which covers an area of about 20000 square meters, will be used for the commercial production of Prochloraz and the production of clinical drugs of freitaphan.

Global war "epidemic" journey

Pioneer pharmaceutical is an innovative drug R & D enterprise established in 2009, focusing on androgen receptor (AR) and tumor related diseases.

Over the past decade, the products of the pharmaceutical industry have mainly covered the high incidence of cancer and other diseases that do not meet the clinical needs, including prostate cancer, breast cancer, liver cancer and hair loss.

The new crown epidemic in 2020 makes the clinical trials of innovative pharmaceutical enterprises generally be impacted. It is found that prochloraz can block ar signal and reduce the expression of ACE-2 and TMPRSS2 protein.

ACE-2 and TMPRSS2 are two key proteins of NCV entering host cells. This means that prochloraz is expected to reduce the deterioration of covid-19 patients from mild to severe.

A global collaboration in the development of new anti epidemic drugs started rapidly.

In June 2020, applied biology, an American biotechnology company, launched a clinical study on patients with a new crown of anti androgen therapy in Brazil, exploring the pharmaceutical industry, and then joined the study to provide relevant drugs and partial funding for the project.

A few months later, pioneer pharmaceutical received good news from Andy Goren, Professor of Brown University, President and chief medical officer of Applied Biology: the clinical trial of Prochloraz in the treatment of covid-19 achieved positive results.

After entering 2021, good news comes frequently:

On January 7, prochloraz significantly inhibited the conversion from mild to severe in male patients with new crown, and the short-term medication (15 days) was safe;

On January 10, the interim data of Prochloraz in female subjects with new crowns were consistent with the results of the previously published clinical trials in male subjects with new crowns;

On January 28, the clinical trial of proclumide in the treatment of severe new crown patients was approved by the Brazilian Independent Review Committee (IRB). Through the rapid review process, 588 critically ill patients will participate in the parallel controlled trial.

Stick to the original intention of starting a business

Pharmaceutical industry has a long history. Today, the giants in the pharmaceutical industry often have a history of 100 years.

In terms of age, the development of pharmaceutical industry is still a new recruit in the pharmaceutical industry. However, Tong Youzhi, founder of the pharmaceutical industry, is a veteran in the "never declining sunrise industry".

Tong Youzhi graduated from the Chemistry Department of Peking University in the 1980s, and then went to the United States to obtain a doctor's degree in pharmacology from Cornell University / Sloan Kettering cancer center, and served as an assistant professor at Albert Einstein Medical College.

In 2002, he was invited by the dean of the Albert Einstein School of medicine to join the company of angion biomedica. As one of the early team members of the company, Tong Youzhi experienced the entrepreneurial process of new drug R & D company.

"Our generation has a general sense of patriotism. When we come back to start a business, we hope to do something for our country, not just technology driven." Tong Youzhi resigned and returned to China in 2008, his wish was to make innovative medicine that Chinese people can afford.

Prochloraz is the first innovative drug project independently developed by the pharmaceutical industry. The ongoing clinical trials in the same period are mainly for patients with prostate cancer and breast cancer.

Lu Yan, CFO of pioneering pharmaceutical industry, told 21st century economic report that two phase III clinical trials of Prochloraz in the treatment of advanced prostate cancer in China are being promoted, and a phase II clinical trial in the United States is in progress simultaneously.

According to the growth rate of new cases, prostate cancer is the second fastest growing cancer among the major cancer types in China, and breast cancer is the most common cancer type for women in the world in 2018.

In fact, by the time the company was listed on the Hong Kong stock exchange, five drugs under development in the pharmaceutical industry had been approved for clinical trials in China, the United States and Taiwan.

Since the introduction of the ALK-1 antibody project awarded by Pfizer, the pharmaceutical industry has expanded its layout in macromolecular drugs, including the R & D and commercialization license of double target antibody PD-L1 / TGF - β of gensun company in Greater China.

Macromolecule small molecule combination

The clinical performance of Prochloraz exceeded Tong Youzhi's expectation, and also made the pioneer pharmaceutical industry win the attention of the capital market. The stock price of the pioneer pharmaceutical industry rebounded rapidly after several months of downturn.

In fact, looking back 10 years, the pioneering pharmaceutical entrepreneurial team has experienced the dawn of China's innovative pharmaceutical industry, and has traveled all the way to the present.

In recent years, the valuation of local innovative pharmaceutical enterprises has reached new highs, and PE / VC investment institutions have stepped into the market.

"At that time, they didn't have any money. A lot of the equipment was second-hand equipment in the United States, which was carried back." Lu Yan told reporters that at the beginning of his business, Tong Youzhi used the mortgage money to pay wages to his employees. He rented his apartment several kilometers away and rode an electric car to work every day.

Pharmaceutical R & D is an industry with long cycle, high risk and high cost. However, at the beginning of pioneering pharmaceutical industry, the haze of the global financial crisis has not disappeared, and innovative drugs have not been widely seen by local investment institutions, so the financial situation of the pharmaceutical industry in the first few years is not optimistic.

The turnaround took place in 2012. Tong you's friend recommended the development of pharmaceutical industry to Lenovo star.

As a result, Lenovo star became an angel investor in the pharmaceutical industry in 2012. When the company went public, the project brought huge returns to Lenovo star.

Not only Lenovo star, but also obtained investment from Yuanhe holdings, Yuansheng capital, Honghui capital, Songhe capital and Shanghai Free Trade Zone fund before listing. In May last year, the company's cornerstone investors included Gree Financial Holdings, Honghui capital and Ruiyuan fund.

Innovative drug research and development, a sword in ten years. At present, pioneer pharmaceutical has five products in clinical development stage and has carried out a number of phase I-III clinical trials in China and the United States. In addition, it also includes PD-L1 / TGF - β double target antibody, protac based androgen receptor degradation agent (AR degrader) and c-myc inhibitor.

It is hoped that in the future, we can strive to transform the company from biotechnology to biopharm and become a closed-loop company with innovation in the whole industry chain. In addition to further improving the R & D strength and striving to reach the international leading level, we can also achieve self-sufficiency in clinical development, production and marketing.

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