Drugs to be launched in China in 2018 (Part I)

In 2017, a large wave of imported and domestic new drugs were quickly approved for listing with the help of priority review. Some lucky ones also caught up with the bus of medical insurance negotiations in some provinces and cities. So what other blockbuster new drugs are worth looking forward to in the Chinese market in 2018? The editor will introduce the upcoming drugs in two phases.

1. Injectable Aibo Weitai-Frontier Biology

Aibo Weitai is a class 1 new drug independently developed by cutting-edge organisms. It belongs to gp41 inhibitor and is the world's first long-acting AIDS drug. On the one hand, it is convenient to administer the drug and can be injected once a week. On the other hand, it is effective for patients with drug resistance. Aibo Weitai received special funding for the creation of major national new drugs.

The application for listing of Aibo Weitai for injection was accepted by CDE on July 18, 2016 and went through the special approval channel. On November 3, 2016, it was included in the priority review by CDE on the grounds of "anti-AIDS, innovative drugs". At present, the technical review (pharmacy, pharmacology and toxicology, clinical) has been completed and is waiting for on-site inspection by the certification center. The three-in-one report (technical review report, on-site verification report, it is expected to be approved for listing in 2018Q1.

2. Nivolumab injection-Brixtime Myers Squibb

Nivolumab is the world's first listed PD-1 monoclonal antibody and was first approved in Japan. Since 2014/12/22 for the first time in the United States to get melanoma indications, has been approved by the FDA nine indications. In 2016, BMS's global sales of Opdivo were $3.774 billion, and in January-September 2017 sales were $3.587 billion (+ 46%).

Nivolumab's application for listing for second-line treatment of NSCLC in China was accepted by CDE on November 2, 2017, and was included in the priority review by CDE on December 18, 2017 on the grounds of "obvious therapeutic advantages compared with existing treatment methods. Although the Nivolumab has not yet entered the review queue, but in view of its clinical efficacy, high degree of concern, and biological drug review tasks are relatively small, almost no backlog, so it is very optimistic that the Nivolumab will be approved quickly.

Taking the same popular osimertinib as a reference (2017/2/3 submitted for listing application, 2017/3/3 included in priority review, 2017/3/24 approved by CFDA), it is optimistic that Nivolumab will be approved for listing in China in 2018Q1, becoming the first PD-1/PD-L1 drug listed in China.

3. Thiepifelstine Injection-Hengrui.

Thiopterostim injection is 19K(HHPG-19K, polyethylene glycol recombinant human granulocyte stimulating factor injection), which can be used for chemotherapy-related neutropenia in tumor patients clinically, because it has obtained the WHO common name and belongs to the new drug of long-acting granulocyte colony stimulating factor (G-CSF) family, rather than the generic drug of Amgen blockbuster Neulasta (polyethylene glycol filostim). Brokers predict that their sales peak can exceed 2 billion yuan.

The listing process of thipefigerstine injection was quite rough. Hengrui submitted a 19K listing application (CXSS1300007) as early as March 4, 2013. After more than 2 years of hard queuing, it caught up with the clinical data self-examination on July 22, 2015. Hengrui announced to withdraw the listing application on May 18, 2016, saying that it would improve the relevant research and development data and supplement the application as soon as possible.

On March 24, 2017, Hengrui re-applied for 19K listing under the name of thiapfigerin injection. It was once included in CDE's priority review list on the grounds of "obvious therapeutic advantages compared with existing treatment methods and major special projects". Although it was not included in the list, the technical review (pharmacy, pharmacology and toxicology, clinical) was completed on October 13, 2017 and is waiting for on-site verification. If it goes well, it is expected to be approved by CFDA in 2017Q2.

　4. Anlotinib Hydrochloride Capsules-Zhengda Tianqing

Anlotinib is a multi-target tyrosine kinase inhibitor, which can effectively inhibit VEGFR, PDGFR, FGFR, c-Kit and other kinases, and has the effect of anti-tumor angiogenesis and tumor growth.

According to the results of the ASCO2017 published ALTER 0303 study of the third-line treatment of advanced NSCLC with erlotinib, erlotinib can significantly prolong OS(9.63 vs 6.30 months) and PFS(5.37 vs1.40 months) and significantly improve ORR(9.18 vs0.7%) compared with placebo control group.

The listing application of anlotinib for the treatment of non-small cell lung cancer was accepted by CDE on March 16, 2017, and went through a special approval channel. On April 27, 2017, it "has obvious therapeutic advantages compared with existing treatment methods; The reason for major special projects was included in the priority review by CDE. At present, the technical review of pharmacology, toxicology and clinical part has been completed, and the pharmacy part is waiting for review. After that, it will enter the site for verification one after another and issue a three-in-one report. It is expected that CFDA approval will be obtained in 2017Q2.

5. Pyrrotinib Maleate Tablets-Hengrui

Piritinib is an EGFR/HER2 small molecule inhibitor, developed for the treatment of HER2 breast cancer, gastric cancer and NSCLC. It has received special funding for the creation of major national new drugs and is a new drug project that Hengrui has high hopes. Up to now, Hengrui has invested 0.52 billion yuan in the research and development project of pyrrolitinib.

In the phase II clinical trial for breast cancer patients who failed anthracycline and taxane therapy and did not exceed 2 lines of chemotherapy after recurrence/metastasis, the objective response rate of pyrrotinib + capecitabine (hereinafter referred to as "pyrrotinib group") was 78.5, and the objective response rate of lapatinib + capecitabine (hereinafter referred to as "lapatinib group") was 57.1. The objective response rate was improved by approximately 21% in the pyrrotinib group compared with the lapatinib group. Median PFS was 18.1 months in the pyrrotinib group and 7.0 months in the lapatinib group, and the risk of disease progression and death was reduced by 63.7 percent in the pyrrotinib group.

In view of the excellent phase II clinical data, Hengrui submitted a conditional listing application for pyrrotinib to treat breast cancer to CDE. The application was accepted by CDE on August 24, 2017 and went through a special approval channel. On September 26, 2017, it was included in the priority review by CDE on the grounds of "having obvious clinical value and major projects. At present, the technical review of the clinical part has been completed, and the pharmacy and pharmacology and toxicology parts are waiting for review. It is expected that CFDA approval will be obtained in 2018Q2.

6. Fruquintinib Capsules-Lilly/Hutchison

Fuquintinib is a small molecule VEGFR inhibitor independently developed by Hutchison Medicine, which is intended to be developed for the treatment of colorectal cancer, gastric cancer and NSCLC, and has received special funding for the creation of major new drugs in the country.

Colorectal cancer is the second most common type of cancer in China, with about 380000 new cases per year. According to the results of Phase III FRESCO study announced by the ASCO2017 Congress, 416 Chinese metastatic colorectal cancer patients who have received more than 2 rounds of systemic chemotherapy were divided into 2:1 groups and treated with fuquintinib and placebo respectively. The median overall survival time was 9.30 vs 6.57 months. Other secondary clinical endpoints such as PFS, ORR and DCR also reached statistically significant differences. Grade 3 or higher adverse reactions were mainly hypertension (21.6%), hand-foot skin reaction (10.8%), proteinuria (3.2%) and diarrhea (3.2%).

The listing application of furosinetinib for the treatment of advanced colorectal cancer was accepted by CDE on June 30, 2017, and on September 4, 2017, it was included in the priority review by CDE on the grounds of "obvious clinical value; Major special projects. At present, the technical review of pharmacology and toxicology has been completed, pharmacy and clinical are waiting for review, and it is expected to be approved by CFDA in 2017Q3. Lilly is mainly responsible for the commercial promotion of fuquintinib after its listing in China.

The next issue will introduce the remaining new drugs that will be listed in China in 2018. Please pay more attention.