Rolontis and Leclaza make their place in Korea

...promising new homegrown drugs settle in Korea

Yuhan’s Leclaza exceeds annual sales of KRW 10 billion for 2 consecutive years since its launch...global trials are also smoothly underway

Hanmi’s Rolontis raises initial sales of KRW 1.5 billion in Korea... starts sales in the US

Leclaza and Rolontis, the homegrown drugs that have gained attention as promising new global drugs, have made a smooth start in the domestic market.

 

Yuhan Corp’s Leclaza’s annual sales exceeded KRW 10 billion in the second year of release, and Hanmi Pharmaceutical’s Rolontis has also started making sales in earnest in the Korean market.

 

◆Yuhan’s Leclaza’s sales exceed KRW 10 billion in only 3 quarters...

 

nears FDA approval According to the market research institution IQVIA on the 28th, Leclaza’s sales in Q3 were KRW 4.6 billion, a threefold increase from the KRW 1.5 billion in the same period of the previous year.

 

Leclaza is the 31st novel drug to be developed in Korea.

 

It received approval as a non-small-cell lung cancer treatment for patients with EGFR T790M mutation-positive, locally advanced or metastatic NSCLC who were previously treated with an EGFR-TKI.

 

It inhibits the signal transduction that is involved in lung cancer cell proliferation and growth to inhibit the proliferation and growth of lung cancer cells.

 

Leclaza entered the Korean prescription market in earnest with its reimbursement listing in July last year.

 

It first made sales of KRW 1.5 billion in Q3 last year and then sold KRW 2.6 billion in Q4.

 

Its sales continued to rise further this year.

 

In Q1 and Q2 this year, it raised sales of KRW 3.2 billion and KRW 3.7 billion and continued its growth in Q3.

 

Leclaza recorded cumulative sales of KRW 11.5 billion in Q3 this year and then exceeded KRW 10 billion in its second year of release.

 

Among new anticancer drugs developed in Korea, Leclaza is the first to raise annual sales that exceed KRW 10 billion.

 

Other homegrown new anticancer drugs that were approved before Leclaza include Il-Yang Pharmaceuticals’ Supect, Dongwha Pharm’s Milican, Chong Kun Dang’s Camtobell, Sam Sung Pharmaceutical’s Riavax, Hanmi Pharmaceutical’s Olita.

 

None of the products have exceeded annual sales of KRW 10 billion.

 

In the early stages of its release, Leclaza is evaluated to have made a smooth start.

 

As anticancer drugs are usually used in large medical institutions, they are only allowed to make prescriptions only after passing drug committee reviews in their respective institutions.

 

Also, as the new drugs need to directly compete with promising new drugs from multinational pharmaceutical companies, it is not easy for local homegrown new anticancer drugs to achieve commercial results.

 

Leclaza passed reviews in drugs committees of major large-scale medical institutions in Korea and started speeding up market penetration.

 

Leclaza is also speeding up entry to the US market.

 

Yuhan Corp made a licensing deal with Janssen biotech in November 2018.

 

Since then, Janssen has been developing the drug in combination with its own EGFR-MET bispecific antibody ‘amivantamab.’ The CHRYSALIS trial which had been the first trial initiated after the agreement was signed, has been now expanded to study its combination with other platinum-based anticancer therapies including ‘carboplatin,’ ‘pemetrexed.’ Janssen is also expected to apply for FDA approval for such combinations within the year at the earliest.

 

The global Phase III trial for the first-line therapy is also in smooth progress.

 

According to a phase III trial recently announced by Yuhan Corp, Leclaza reduce the risk of disease progression or death by 55% compared to Iressa and statistically significantly improved progression-free survival, the primary endpoint.

 

PFS is an important evaluation index used to confirm the efficacy of anticancer drugs and refers to the period that a patient lives with the disease without progression or death.

 

The Phase III trial has been conducted on 393 treatment-naive patients with EGFR-positive locally advanced or metastatic non-small-cell lung cancer.

 

Yuhan Corp received approval to conduct the clinical trial in December 2019 from the Ministry of Food and Drug Safety, and 119 institutions in 13 countries participated in the trial.

 

Based on the trial results, the company plans to apply for its use as a first-line treatment.

 

◆Hanmi’s Rolontis first makes KRW 1.5 billion this year...

 

starts sales in the US market Hanmi Pharmaceutical’s Rolontis which recently entered the US market started to raise sales in earnest in Korea.

 

2 Rolontis recorded KRW 1 billion in the Korean market in Q3.

 

It made sales for the first time in Q1 this year and then sold KRW 0.4 billion in Q2.

 

As of Q3, its cumulative sales reached KRW 1.5 billion.

 

Rolontis is a new biological drug that Hanmi Pharmaceutical transferred the technology to Spectrum in 2012.

 

It is administered to prevent or treat neutropenia in cancer patients that receive myelosuppressive chemotherapy.

 

The drug has a similar mechanism of action to Amgen’s blockbuster drug ‘Neulasta (pegfilgrastim),’ by increasing the G-CSF receptor to stimulate neutrophil production.

 

The drug was approved as the 33rd homegrown new drug in March and started to be sold in Korea after receiving reimbursement in November last year.

 

Rolontis was approved under the brand name Rolvedon by the US FDA in September this year and succeeded in commercialization 10 years after its technology transfer.

 

Rolvedon is now recorded as the 6th product to pass FDA review among new drugs developed with a Korean company’s technology.

 

LG Chem’s Factive was the first among homegrown new drugs to pass the US gates in 2003.

 

Then, Sivextro that Dong-A ST licensed out was approved by the FDA in 2014.

 

Then, in 2016, SK Chemical’s hemophilia drug Abstyla received FDA approval.

 

In 2019, SK Biopharmaceutical’s narcolepsy drug Sunosi and new epilepsy drug Xcopri received FDA approval.

 

Rolontis is the first drug to receive marekting approval from the FDA among Hanmi Pharmaceutical’s products.

 

It is the first new drug to be produced in the US market and produced at a domestic plant (Pyeongtaek Bio Plant) that has received on-site inspections from the FDA.

 

It is the first new drug to be produced in the U.S.

 

market and produced at a domestic plant (Pyeongtaek Bio Plant) that has received an on-site FDA inspection.

 

Rolontis started selling in the US market in earnest last month.

 

The US neutropenia treatment market is worth KRW 3 trillion a year.

 

With Spectrum failing to introduce another anticancer drug it brought in from Hanmi Pharmaceutical, poziotinib, to the US, the company has expressed aims to focus on the commercial success of Rolontis.

 

After failing to receive approval for poziotinib, Spectrum planned to start restructuring, including a 75% reduction in R&D personnel by the end of the year, and concentrate the saved operating funds on Rolontis.