2018 These new drugs focus on the global eye!

Medical Network February 6th Recently, FirstWord has carried out a detailed analysis of new dosage forms and new indications for new drugs and listed products that are expected to seize the headlines of 2018, and roughly outlines the bumper harvest of new drug research and development in this year.

New drug

Bictegravir

[indications] HIV

[Company] Gilead Science

It is expected that Gilead Sciences will regain its dominance in the AIDS drug market this year with its new compound preparation of the integrase inhibitor bictegravir. This new compound product is a triple compound anti-AIDS drug that combines bictegravir with emtricitabine and tenofovir alafenamide (TAF) at a fixed dose (50/200/25 mg). Gilead is expected to use this new product to weaken the momentum of Tivicay and Triiumeq of GlaxoSmithKline's ViiV.

Despite the strong growth of Tivicay in recent years, the two-in-one compound preparation developed by ViiV seems to have no curative effect, because although its side effects are reduced, some people think that the compound preparation is more resistant to drug resistance, so it does not help the market competition.

Epacadostat

[indications] melanoma

[company] Incyte

This year will further confirm whether the combination of PD-(L)1 and IDO inhibitors is effective for melanoma treatment. Although the data from Phase II non-randomized clinical trials are impressive, the need to establish a new benchmark for clinical treatment has to wait for the results of the Phase III clinical study of ECHO-30. The study combines Mertr & Co.'s Keytruda and Incyte's epacadostat for first-line treatment of melanoma, which is expected to be completed in the first half of this year.

Early data showed that the efficacy of Keytruda in combination with epacadostat was comparable to that of Bristol-Myers Squibb's PD-1/CTLA-4 combination therapy (Opdivo/Yervoy) with fewer side effects. If the latest study yields positive data, the expected outcomes of Phase III trials for other tumors, including first-line treatment of NSCLC, will also increase.

Ozanimod

[indications] multiple sclerosis

[Company] New Base Medicine

Roche's Octreus was born last year and successfully occupied the market for multiple sclerosis. It is not known whether Celgene's Ozanimod can replicate its brilliance. Ozanimod's efficacy is comparable to the oral drug Gilenya, with fewer side effects, reducing the need for post-medication monitoring, and neurologists sometimes switch to other drugs because of Gilenya's side effects. Ozanimod's Phase III clinical data reflects its advantages, but there are still some opinions that the prospect of the drug is not optimistic, especially the Gilenya generics will also be on the market.

Olumiant

[Indications] Rheumatoid arthritis

[Company] Lilly

Eli Lilly responded quickly to the FDA's potential safety issue with Olumiant, which is expected to resubmit the listing application for this JAK inhibitor to the FDA earlier this year and seek approval before the end of the year. Industry experts are impressed with the efficacy of Olumiant, and Lilly needs to gain momentum from new products.

Olumiant will apply for a new drug for 2018 immunizations: a new phase III clinical data will continue to show the efficacy of AbbVie's upadacitinib in patients with rheumatoid arthritis (RA), which may eventually be submitted to the FDA at the end of the year. Application; phase III clinical data of JAK inhibitor filgotinib in the treatment of RA jointly developed by Gilead and Galapagos, and all phase III clinical trials of the monoclonal antibody risankizumab developed by Abbott and Boehringer Ingelheim for the treatment of psoriasis The data will be announced in the first half of this year. In the context of the stagnation of TNF monoclonal antibodies, the emergence of these new drugs has become a new bright spot in this therapeutic field.

Aimovig

[indications] migraine

[Company] Anjin / Novartis

Aimovig, jointly developed by Amgen and Novartis, is expected to receive FDA approval by May 17, which will be the first CGRP (calcitonin gene-related peptide) inhibitor to enter the migraine drug market. The other three CGRP inhibitors are getting closer and closer (the anti-CGRP drugs jointly developed by Teva and Lilly are also likely to be approved by the FDA this year), which will bring fierce market competition. These antibody drugs are in prevention and It has similar efficacy in reducing the frequency of migraine development. Important clinical data for two oral CGRP inhibitors will also be published in 2018.

Lanadelumab

[indications] hereditary angioedema

[Company] Charles Pharmaceuticals

In May last year, Shire announced the positive phase III trial data of lanadelumab for the treatment of hereditary angioedema (HAE), which is expected to be submitted to the FDA soon and will be reviewed by the end of 2018. result. Lanadelumab is the "successor" of Charles's preventive treatment, Cinryze, which will compete with Hagarda of CSL Behring for the HAE market, which was approved by the FDA in June last year. Shire is working hard to improve the convenience of lanadelumab, making it a new selling point, both of which will benefit from the expanding preventive drug market.

Rova-T

[indications] small cell lung cancer

[Company] Aberdeen

In 2017, Aberdeen’s stock rose significantly, mainly because the company’s best-selling drug , Humira’s patent protection in the US, will not expire until at least 2020, which gives investors confidence in Abbott. Keep rising.

At the same time, Aberdeen is still working hard to develop new products. The company's Phase II clinical study of the efficacy of Rova-T on small cell lung cancer (TRINITY study) will be available this year, which may pave the way for a listing application later this year. In 2016, Abbott earned Rova-T's patent for a $5.8 billion acquisition of Stemcentrx, which has high hopes.

Multiple cystic fibrosis therapy

【Company】Futai Pharmaceutical, Galapagos

Analysts believe that Vertex Pharmaceuticals remains the "prey" for pharmaceutical giants to watch, as a new round of Phase II clinical data for the development of triple-conjugated drugs for cystic fibrosis will be available this year, and Its VX-661/Orkambi compound (for patients with cystic fibrosis of the CTFR gene F508del mutation at 12 years of age and older or homozygous) is also expected to receive FDA approval. But the company's future competitive threats may also be more prominent, because Galapagos' new cystic fibrosis drug is also outstanding, although it is about two years later than Forte Pharmaceuticals.

Larotrectinib

[Indications] TRK fusion cancer

[Company] Loxo Oncology / Bayer

Larotrectinib is mainly used for the treatment of adult and child patients with NTRK fusion gene, inoperable resection or metastatic solid tumor, regardless of tumor tissue type. Loxo announced last month that it has submitted a new round of new drug applications for larotrectinib to the FDA. Not long ago, Loxo and Bayer reached a joint development relationship with larotrectinib. During this period, Roche also acquired the biotechnology company Ignyta. The latter's entrectinib is also used to treat solid tumor patients carrying the NTRK fusion gene.

Last year, Merck's Keytruda received FDA approval as the first treatment for a variety of solid tumors for specific gene mutations, either by microsatellite instability (MSI-H) or mismatch repair deletion (dMMR) gene mutations. Caused by a non-surgical removal or metastatic solid tumor.

ALXN1210

[Indications] Paroxysmal nocturnal hemoglobinuria

[Company] Yali Brother Pharmaceutical

Alexion Pharmaceuticals' ALXN121 treatment for new and transformed paroxysmal nocturnal hemoglobinuria (PNH) phase III clinical trial results will be available later this year, if the data is optimistic, the company is in biotechnology The field will receive new attention, and ALXN1210 is also expected to replace Soliris as the best-selling product of Yali Brothers.

There are more competitors in the PNH field, and Yali’s expectations for the ALXN1210 are also rising. The ALXN1210 or license gives patients more convenience, but the key is whether it has a therapeutic advantage.

AVXS-101

[Indications] Spinal muscular atrophy

[Company] AveXis

At the end of 2016, Spinraza, jointly developed by Biogen and Ionis Pharmaceuticals, was approved for marketing and became the first treatment for spinal muscular atrophy (SMA). Now AveXis also wants to share a piece of the pie, based on strong Phase I clinical data, the new drug AVXS-101 can be submitted later this year for the treatment of patients with type 1 SMA. At the same time, Baijian will also launch its clinical trial of experimental gene therapy for SMA patients.

Epidiolex

[Indications] Lennox-Gastaut/Dravet syndrome

[Company] GW Pharmaceutical

In recent years, CG Pharmaceutical's Epidiolex clinical support data has been steadily accumulating, and recently it has entered the stage of market review. It is expected to receive FDA approval later this year for the treatment of Lennox-Gastaut syndrome (also known as childhood diffuse). Sexual slow spine - slow wave (small episode variant) epilepsy encephalopathy) and Dravet syndrome (also known as severe myoclonic epilepsy in infants ).

Patisiran

[Indications] Hereditary ATTR amyloidosis

[company] Alnylam / Sanofi

In September last year, Alnylam Pharmaceuticals and its partner Sanofi announced the first positive data for its Phase III clinical study of its RNAi drug Patisiran and quickly submitted a FDA application for the drug. Patisiran is mainly used for the treatment of hereditary ATTR amyloidosis and is expected to be approved for marketing in 2018 or 2019.

Apalutamide

[indications] prostate cancer

[Company] Johnson & Johnson

Johnson & Johnson has not yet published data on advanced clinical studies of apalutamide, but it has submitted a FDA application for apalutamide for the treatment of non-metastatic castration-resistant prostate cancer (CRPC), which the FDA recently granted. Pharmacy priority review qualification. In 2013, based on Apalutamide (formerly known as ARN-509) in Phase II clinical data from CRPC, Johnson & Johnson acquired Aragon Pharmaceuticals with a $650 million advance payment plus a $350 million milestone.

New dosage form / new indication

Semaglutide (oral dosage form)

[indications] diabetes

[Company] Novo Nordisk

At the end of last year, Novo Nordisk's Ozempic (semaglutide) was approved by the FDA and is expected to strengthen its leading position in the GLP-1 agonist market. If the oral dosage form of semaglutide can also obtain positive phase III clinical trial data, its market position will be further improved. Experts believe that if the efficacy of oral semaglutide is comparable to that of injections, the drug will likely revolutionize the treatment of diabetes and accelerate the use of GLP-1 drugs in the early treatment of diabetes.

PD-1/L1 inhibitor

[indications] non-small cell lung cancer

[Company]

2018 may be the key year to determine how PD-1 and PD-L1 inhibitors work in first-line treatment of non-small cell lung cancer (NSCLC). Phase III clinical trial data from AstraZeneca and Bristol-Myers Squibb will be published to determine whether the efficacy of PD-(L)1/CTLA-4 inhibitors in combination with NSCLC is Better than chemotherapy.

Although the confidence in this combination therapy has gradually declined over the past year, the combination of PD-(L)1 and chemotherapy has been proven and won recognition. By the end of this year, the results of the combination of PD-(L)1/CTLA-4 inhibitors with current standard therapies will also be available.

Recently, Merck announced that Keytruda combined with chemotherapy (pemetrexed and platinum drugs) first-line treatment of metastatic non-squamous NSCLC in the key phase III KEYNOTE-189 study has achieved encouraging results, which can significantly prolong overall survival and no progress Survival period.

Imfinzi

[Indications] Phase III NSCLC

[Company] AstraZeneca

Last year, AstraZeneca slammed a victory, as its Phase III PACIFIC trial yielded positive results, suggesting that the PD-L1 inhibitor Imfinzi can significantly improve Phase III NSCLC that previously responded to existing standard therapies. Progressive survival of the patient. AstraZeneca is expected to update the overall survival data for this study later this year, which may ensure that Imfinzi's new indication is approved by the FDA and EMA. Then, the company's focus will be to increase the doctor's use of the drug, because in the treatment of stage III NSCLC patients, Imfinzi is expected to lead other PD-(L)1 inhibitor competitors for 2 to 3 years and benefit in advance.

In addition, last year's first CAR-T therapy – Novartis's Kymriah and Gilead's Yescarta were approved for listing. This year, the market is still the focus of the pharmaceutical industry, and people are watching the commercialization of this revolutionary scientific achievement. No success.

The FDA will also conduct a detailed review of the new data for JCAR017 from Juno Therapeutics to see if the effectiveness and safety of this CAR-T therapy is advantageous. Its early data is more eye-catching, but the report at the ASH annual meeting last November showed no surprise.

At the same time, the commercialization of the gene therapy Luxturna by Spark Therapeutics has also received widespread attention.