Local Anti Cancer Drugs Approved Locally Listed In Baiji Shenzhou Hematoma Area

Following the approval of the US Food and Drug Administration (FDA) at the end of 2019, in June 3rd, the official website of the National Drug Administration (NMPA) announced that it was approved by the priority review and approval process with the approval of the 1 innovative drugs, the zipitinib capsule (trade name: Baiyue Ze), which was used for the patients who had received at least one treatment of adult mantle cell lymphoma (MCL). Adult patients with chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) who had received at least one treatment before.

It is a selective inhibitor of Bruton's tyrosine kinase (BTK). It is also an innovative drug developed by China and has its own intellectual property rights. The State Food and drug administration has requested that the holders of drug listing will continue to confirm the clinical research as planned after the listing of this product.

This is the second commercially developed proprietary drug developed after the approval of the PD-1 drug for ralezumab.

Compared with 6 listed PD-1 drugs market in China, the competitive advantage of Baiji Shenzhou in the BTK inhibitor market seems to be stronger: the first BTK inhibitor in the world has been developed by Johnson (Yang Sen) and AI Bo Wei jointly developed by Ibrahimovic (Imbruvica), the second is AstraZeneca's Acate Ni (acalabrutinib), and the zanubrutin of Baiji Shenzhou (zanubrutin). IB) is the third listed BTK inhibitor in the world.

Baiji Shenzhou also has high hopes for CHB. In 2019, Baiji Shenzhou ranked the top of domestic pharmaceutical companies with more than 6 billion 600 million yuan of R & D investment. Although it sold three new drugs, the industry paid more attention to the commercialization of its products.

In the first quarter of 2020, the income of the products in the United States was $720 thousand. For future market prospects, Wu Xiaobin, general manager and chief executive of China, said in a subsequent press conference: "the BTK inhibitor of Zebti Ni is a market from scratch. Because of the efficacy of BTK, chronic lymphocytic leukemia has become a chronic disease. The market potential of BTK inhibitors is very large and must be one of our flagship products. "

Johnson and AstraZeneca also value their BTK very much in their earnings reports. They have repeatedly mentioned the potential of market growth in the future, and the global commercialization process of Baiji Shenzhou is just beginning.

8 years: from Changping to the United States

Lymphoma is a group of malignant tumors originating from lymphohematopoietic system. It is one of the ten most common malignant tumors in China. According to epidemiological statistics, non Hodgkin lymphoma (NHL) accounts for 91% of all lymphoma cases, including 66% of B cell non Hodgkin's lymphoma, in 88200 new cases of lymphoma in China every year. Among them, mantle cell lymphoma (MCL) accounts for about 5% of all B cell non Hodgkin's lymphoma, while chronic lymphocytic lymphoma (CLL) / small lymphocytic lymphoma (SLL) accounts for 6% of all B cell non Hodgkin lymphoma.

The two approved indications for the implementation of the disease in mainland China are based on data from two key clinical studies. Data from the BGB-3111-206 study of a pivotal 2 phase multicenter clinical trial in China showed that the total remission rate of R/R MCL treated with single dose of R/R was 84% and the complete remission rate was 69%. In another BGB-3111-205 study of China's pivotal 2 phase multicenter clinical trial for R/R CLL/SLL, the total response rate was 62.6%, the complete remission rate was 3.3%, the partial remission rate was 59.3%, and 22% of the patients had partial depression with lymphocytic growth.

It is in the research and development center of Changping, Beijing. In June 2012, the research team formally launched the project for BTK development. After a series of screening and testing, the final candidate molecule was selected from more than 500 compounds and numbered BGB-3111, meaning 3111st compounds made after the establishment of Baiji Shenzhou.

From the laboratory project to the present two places in China and the United States, the development of the 8 years of the time of the development of the last year was revealed. Baiji Shenzhou said that the clinical trials launched by sib tinib are currently in the world nearly 25, clinical trials covering more than 20 countries, and more than 500 international clinical experts have participated in or chaired their relevant clinical trials, including more than 70 clinical experts from China. Over the world, over 1700 patients have received the treatment of the capsules.

"We believe that the chabatinib is the best BTK for best-in-class in the world," said Wang Lai, senior vice president of global research and Asia Pacific clinical development in the world. It has two main differences from other BTK in the world. "The first effect is better, and its inhibition on targets is more complete and lasting. Second, the security is better and the targets are more specific. The Miss effect is very small, resulting in less toxic side effects. "

In April 2013, Baiji Shenzhou filed a patent application, which is a global patent originated from the Chinese patent office, which means it is a new anti-cancer drug developed locally in China. In 2014, the first clinical application of the drug was introduced in Australia. In August of the same year, the first patient was given medicine.

Wang Lai explained, "at that time, the main reason for going to Australia was that the reform of China's pharmaceutical administration had not yet reached the point of acceleration. At that time, a new drug had to be listed for a long time, while in Australia it was relatively fast, and their ability to do clinical trials was also very strong. The doctors were very experienced."

Yan Xiaojun, senior vice president and chief of global pharmaceutical affairs, has divided the 8 years into four phases. 2012-2013 years of drug development, pre pharmacology and toxicology experiments; 2014-2015 start IND and clinical trials; 2016-2017 clinical trials; 2018 to date, new drug application (NDA) and listing. "In 2016, our communication with the drug review center identified a 2 phase clinical support with a single arm, which accelerated the overall R & D and listing."

In a series of clinical trials, it has shown good efficacy and safety in MCL, CLL and other B cell lymphoma. In November 2019, zerb was approved by FDA for the treatment of patients with mantle cell lymphoma who had received at least one treatment before. It became the first locally researched and new anticancer drug approved in the United States.

At present, they have not been approved in the US and other countries outside China, but they have accelerated the process of globalization. In May 21st, Baiji Shenzhou announced the signing of the exclusive proxy distribution agreement with Israel Medison Pharma in Israel. Medison will have the right to carry out commercialization activities in Israel against the CHB. At the same time, the two sides also submitted applications for new drugs in Israel. Baiji Shenzhou said it will also communicate with the European Medicines Agency (EMA) this year.

For the subsequent production, Wang Zhiwei, one of the chief inventors of the Chai, "the construction process is very long. In 2015, we thought that this drug could be firmly established in the world, and then it was commercialized in the world." In 2015, Baiji shenzhou first found a collaborator Catalent in the United States, and set up a company in Suzhou in the same year as the first small molecule production base. With an investment of several hundred million yuan, it has an area of 13299 square meters, with 205 employees and an annual capacity of 100 million capsules. Its raw materials are produced by the pharmaceutical company, and the exclusive production line is provided for Baiji Shenzhou.

Acceleration of Globalization

In 2013, BTK inhibitor Ibrahimovic was approved to be listed in the United States. According to Johnson's 2019 earnings report, its sales revenue was $3 billion 411 million, an increase of 30.4% over the same period, of which the US market revenue was 1 billion 555 million dollars (+37.7%), and the rest of the world's revenue was $1 billion 856 million (+24.9%).

According to AstraZeneca's 2019 earnings report, another BTK inhibitor, Calquence, which was approved in November 2019, has a revenue of about $160 million a year, mainly in the US. AstraZeneca chief executive Pascal Soriot also emphasized that the listing of Calquence is expected to have a beneficial impact on the growth of total revenue in 2020. "These new drugs are the backbone of the main areas of treatment, and also an important platform for future growth."

The most direct competition is price. In 2017, Ibrahimovic listed in the Chinese market for Nigeria, a box of 90 pieces of Ibrahimovic sold for 48600 yuan for the Nigeria, and in 2018, Ibrahimovic reduced the price of Ni to 17010 yuan.

Baiji Shenzhou has not yet announced the price of the chipburi in China, Wu Xiaobin said. "The innovative drugs we developed independently can make the people get more accessibility and affordability, and believe that the price will have more advantages, and we hope to use a very popular price."

For the future global competition, Wu Xiaobin said, "the sales figures of the first quarter of the year in the first quarter of the year are below the plan. Mantle cell lymphoma is a very small indication in the United States. The biggest significance of its listing is the establishment of our team and the gradual establishment of links with doctors and related institutions. Corresponding growth. "

Another competition comes from clinical layout and joint development. AstraZeneca and Johnson released their data on the combination of BTK inhibitors and other drugs in 2019.

At present, Baiji Shenzhou is carrying out 16 clinical studies on the whole world. At the same time, we are conducting 2 Comparisons of Ibrahimovic global clinical 3 phase head to head research on WM and CLL. It is the first local new drug in China to launch a direct and effective research with foreign pharmaceutical companies.

For the future clinical study and choice of indications for Ibrahimovic, Wang Lai told the twenty-first Century economic report that "the listing of Ibrahimovic for Nigeria is 6 years ahead of us. For B cell lymphoma, one of the more important pathways is BTK and the other is BCL2. Baiji Shenzhou now has many joint plans with BCL2, including the use of Rumei, including follicular lymphoma and diffuse large B cell lymphoma. Drug combination is a general trend for cancer. We hope there will be more synergy in the future.

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