Take a look first! The 12 Heavyweight Anticancer Drugs to Be Launched in 2018 at Home and Abroad!

• by EVOMT
• 2018-01-21

The year 2018 has already begun. In this new year, which cancer treatment related drugs will be listed in the United States and which drugs will be listed in China? Let's make a prediction together

U.S.A

1、Epacadostat

Epacadostat is undoubtedly a dazzling new star in the field of IDO. Clinical trial results show that the combination of IDO inhibitors and programmed death receptor 1 (PD-1) monoclonal antibodies is superior in some aspects to the use of PD-1 monoclonal antibodies alone. The company has reached a cooperation agreement with the two giants of PD-1 monoclonal antibodies, Merck and BMS, and has also extensively explored the combined functions of Epacadostat with other immune checkpoint inhibitors, with indications covering multiple cancer categories, However, Incyte seems not satisfied with this, and their every move has received great attention. In October, Incyte purchased the global development and commercial rights for all indications of MacroGenis' PD-1 monoclonal antibody drug MGA012, further expanding its PD-1 pipeline. I believe that the joint use of MGA012 and Epacadostat will soon begin

2、Rova-T

Rova-T is an antibody drug targeting DLL3 protein on the surface of cancer stem cells, which is still in the experimental stage for the second line combined treatment of small cell lung cancer. AbbVie believes that Rova-T combined with Opdivo or Opdivo+Yervoy will make it a winner in small cell lung cancer, but its ultimate success requires more clinical trials to confirm

3、ARN-509

Apalutamide (ARN-509) is a new generation of anti androgen drugs developed for the treatment of prostate cancer. Johnson&Johnson has been quietly promoting the clinical research and development of Apalutamide, although these data have not yet been seen, it is also an exciting event to see it move towards regulatory agencies. With the strong business development team of Johnson&Johnson, this product is expected to become a blockbuster drug

China

1. Patuzumab

On January 2, 2018, the listing application of Roche's blockbuster breast cancer drug Perjeta (Patuzumab) in China was accepted by CDE

As early as June 2012, patuzumab was approved by the FDA to be used in combination with trastuzumab and docetaxel for metastaticfile breast cancer that has not received anti-HER2+therapy or chemotherapy. In September 2013, patuzumab was accelerated by the FDA to be used in combination with trastuzumab and chemotherapy for neoadjuvant treatment of HER2+breast cancer. On December 20, 2017, the FDA approved the use of patuzumab in combination with trastuzumab and chemotherapy, It is used as adjuvant therapy for early HER2+breast cancer patients with high risk of recurrence. Meanwhile, FDA has changed the accelerated approval of new adjuvant therapy for HER2+breast cancer from accelerated approval to full approval

After submitting a listing application in China, Patuzumab is expected to receive priority review from CDE and provide new treatment options for Chinese patients

2、Opdivo

Opdivo is one of the most widely used PD-1 monoclonal antibodies in clinical practice, and has been successively approved by the FDA for nine indications

Opdivo's application for the second line treatment of non small cell lung cancer in China was accepted by CDE on November 2, 2017, and was included in the priority review by CDE on December 18 for the reason of "significant therapeutic advantages compared to existing treatment methods." It is optimistic that Nivolumab will be approved for marketing in China in Q1 2018, becoming the first PD-1/PD-L1 drug to be listed in China

3. Thiopeneglastine injection

Thiopeneglastine injection, known as 19K (HHPG-19K, polyethylene glycol recombinant human granulocyte stimulating factor injection), can be used clinically for chemotherapy-related neutropenia in cancer patients

As early as March 4, 2013, 19K submitted its listing application (CXSS1300007), but it seemed that the listing was imminent, but it caught up with the clinical self examination on July 22, 2015. On May 18, 2016, Hengrui issued a notice to withdraw 19K's listing application, and said that it would improve relevant research and development data and supplement the application as soon as possible

On March 24th, 2017, Hengrui reapplied for the 19K listing under the name of Thipefeneglastine Injection, and once appeared in the CDE's priority review list for the reason that it had "significant therapeutic advantages compared to existing treatment methods, and significant special items." Although it was not included in the final review, the technical review was completed on October 13th, 2017, and is awaiting on-site verification. If successful, it is expected to obtain CFDA approval in Q2 2018

4. Androtinib

Androtinib is a multi target tyrosine kinase inhibitor that can effectively inhibit VEGFR, PDGFR, FGFR, c-Kit, and other kinases. It has the effect of anti tumor angiogenesis and inhibiting tumor growth, and has received special funding for national major new drug development

"The listing application of arotinib for the treatment of non small cell lung cancer was accepted by CDE on March 16, 2017, taking a special approval channel. On April 27, 2017, it was included in the priority review by CDE for the reason of" having significant therapeutic advantages compared to existing treatment methods "and" major special projects. "Currently, the technical review of the pharmacology, toxicology, and clinical parts has been completed, and the pharmaceutical part has been queued for review. After that, it will successively enter the on-site inspection and issue a three-in-one report.", It is expected to obtain CFDA approval in Q2 2018

5. Pyrrolidine

Pyrrolitinib, a small molecule inhibitor of EGFR/HER2, was developed for the treatment of HER2+breast cancer, gastric cancer and NSCLC, and won the national special fund for major new drug development. It is a new drug project that Hengrui has high hopes for

Hengrui submitted to CDE the conditional marketing application of pyrrolitinib for breast cancer treatment. 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 of CDE for the reason of "having obvious clinical value and being a major special project". At present, the technical review of the clinical part has been completed, and the pharmaceutical and pharmacological toxicology parts are queued for review. It is expected to be approved by CFDA in 2018Q2

6. Furoquitinib

Furoquitinib is a small molecule VEGFR inhibitor independently developed by Hehuang Pharmaceutical. It is intended to be developed for the treatment of colorectal cancer, gastric cancer, and NSCLC, and has received special funding for national major new drug development

The marketing application of furoquitinib for the treatment of advanced colorectal cancer was accepted by CDE on June 30, 2017, and was included in the priority review by CDE on September 4, 2017 for the reason of "having significant clinical value; significant special projects." Currently, the technical review of the pharmacological and toxicological aspects has been completed, and the pharmaceutical and clinical queues are pending review. It is expected to obtain CFDA approval for marketing in Q3, 2018

7. Olapali

"Lynparza is the first PARP inhibitor to be launched globally based on the DNA damage response (DDR) mechanism. It was first approved by the FDA in December 2014 for use in the fourth line treatment of advanced BRCA+ovarian cancer. On July 17, this year, it was approved by the FDA for use in the second line maintenance treatment of adult ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer patients who respond to platinum drugs and have recurrent diseases. To date,", Lynparza has treated over 30000 patients with advanced cancer

On October 18, the marketing application (sNDA) of Lynparza for BRCA mutation and HER2 metastaticfile breast cancer, which was submitted to FDA by AstraZeneca/MSD, was accepted by FDA and qualified for priority review. The applicable population is expected to be significantly expanded

The application for the second line treatment of ovarian cancer in China was accepted by CDE on December 1, 2017. It is the first imported new drug to apply for listing in China using international multicenter clinical trial data after the three reports and three batches were cancelled. As the application for listing has just been submitted for half a month, the possibility of subsequent inclusion in the priority review by CDE is extremely high, and it is expected to obtain CFDA approval for listing in Q3 2018

8. Remvastinib

Remvastinib is a multi target kinase inhibitor that can block tumor cells including VEGFR1-3, FGFR1-4, PDGFR&alpha A series of regulatory factors, including KIT and RET, were approved by the FDA as priority review and orphan drugs on February 13, 2015 for use in the treatment of high-risk differentiated thyroid cancer that is refractory to radioactive iodine. On May 13, 2016, they were approved by the FDA to treat advanced renal cell carcinoma that has previously received anti VEGF therapy in combination with Afinitor

On the indications for liver cancer, Eisai submitted a marketing application in Japan in June 2017, a marketing application to the EMA and FDA in July 2017, a marketing application to the CFDA on November 3, 2017, and a priority review by CDE on December 18, 2017. The FDA granted the orphan drug qualification for the treatment of hepatocellular carcinoma with rivatinib, and accepted Eisai's sNDA on September 27. The approval decision was made in accordance with the 10-month standard review process, An approval decision will be made by the end of July. Remvastinib is expected to receive CFDA approval in China by Q4 2018

9. Seretinib

Seretinib is a second generation anaplastic lymphoma kinase (ALK) inhibitor. On April 29, 2014, it was approved by the FDA for use in the treatment of ALK+non small cell lung cancer that is intolerant to or progression of the disease with clonidinib. On May 26, 2017, it was approved by the FDA for first-line treatment of ALK+metastaticfile non small cell lung cancer

The marketing application for Seretinib capsules submitted by Novartis was officially accepted by CDE on December 11, 2017, and there should be no suspense if it is included in the priority review later (the clinical application has received priority review). It is expected to obtain CFDA approval by Q4, 2018

The above summarizes the cancer treatment related drugs that may be launched in the United States and China in 2018, covering lung cancer, stomach cancer, liver cancer, breast cancer, ovarian cancer and other major cancers. I hope these drugs will come to Chinese patients as soon as possible to protect their health