[헬스코리아뉴스 / 이순호] Im In-nyeon (壬寅年) The combination of Jeon Seung-ho and Lee Chang-jae, who have been leading Daewoong Pharmaceutical since the new year, broke off a good start. In addition to the commercialization of new drugs to treat gastroesophageal reflux disease, which has not been able to get out of review by regulatory authorities for a long time, a green light has turned on, and the botulinum toxin preparation, which has suffered ups and downs in clinical trials in China, has started the local approval process.
Not only has the voice of concern over the delay in commercialization of the main pipeline been erased, but these products are expected to quickly settle in the market and generate sales.
Daewoong Pharmaceutical received approval from the Ministry of Food and Drug Safety on the 30th of Gurab to market a new drug for gastroesophageal reflux disease, ‘Fexuclu’ (ingredient name: fexuprazan hydrochloride).
‘Fexuclu’ is the best-in-class new drug in the gastroesophageal reflux disease family developed by Daewoong Pharmaceutical. It is a P-CAB (Potassium-Competitive) Acid Blocker).
With this approval, ‘Fexuclu’ became the 34th domestic drug and the second domestic P-CAB-based new drug to treat gastroesophageal reflux disease successfully commercialized.
Daewoong Pharmaceutical applied for a product license for ‘Pexuclu’ to the Ministry of Food and Drug Safety in November 2019. It took more than two years to review the permit. Even for a new drug, it is considered unusual given that the approval review process usually takes about a year.
According to the industry, the biggest reason for the delay in the approval review of ‘Pexuclu’ is the outbreak of the new coronavirus infection (Corona 19). The first confirmed case of COVID-19 in Korea was in January 2020. This is right after Daewoong Pharmaceutical applied for marketing approval for ‘Pexuclu’.
Since then, as the spread of COVID-19 has accelerated out of control, health authorities, including the Ministry of Food and Drug Safety, have set quarantine as a top priority. The Ministry of Food and Drug Safety’s work focused on urgent issues such as supply of masks, support for the development of COVID-19 treatments and vaccines, and approval review, and ‘Pexuclu’ was pushed down to the next priority. As a result, it took about two years and one month after submitting the application to obtain the permit.
In the meantime, there have been many voices of concern in the market over the delay in the approval of ‘Pexuclu’. This is because HK Innoen’s ‘K-Cap’ (tegoprazan), the biggest competitor and the first domestic P-CAB-based new drug, is rapidly increasing its market share by preoccupying the market. It was pointed out that if the permit is delayed, it could be difficult to pursue.
However, as the product license fell before 2021, ‘Pexuclu’ will be able to catch up with ‘K-Cap’ from this year. The company plans to immediately apply for insurance drug prices and launch the product within the first half of this year.
The size of the domestic gastroesophageal reflux disease treatment market is estimated at 470 billion won. In the past, this market was dominated by proton pump inhibitors (PPIs), but after the advent of ‘K-cap’, a P-CAB drug, the market is quickly giving away the lead.
Sales of ‘K-Cap’, which caused a sensation at the same time as its launch in 2019, are likely to exceed 100 billion won this year. As such, the market demand for P-CAB-based drugs is overflowing. ‘Pexuclu’ is highly likely to be the second P-CAB drug to be launched on the market after ‘K-Cab’. Previously, Takeda Pharmaceutical received approval for ‘Bosin Tea’ (ingredient name: Bonoprazan, overseas product name: ‘Takecap’), but it is still unclear whether or not to launch it.
Considering that there is only one competing drug in the same class, ‘K-Cap’, and Daewoong Pharmaceutical has one of the strongest sales forces in the industry, ‘Pexuclu’, like ‘K-Cap’, is likely to become a blockbuster product in a short period of time. very high If it is released in the first half of the year, it is expected to generate considerable sales from this year. This is directly reflected in the company’s performance.
Chang-jae Lee, the new CEO, is expected to actively pursue ‘Pexuclu’ in the domestic market. Unlike President Jeon Seung-ho, who specializes in overseas business, President Lee Chang-jae has been recognized for his domestic sales and marketing capabilities and has been promoted to the position of president.
In particular, ‘Pexuclu’ is expected to be fully prepared for successful commercialization, as it is the first large-scale product that President Lee takes on after taking office as president and can serve as a test bed for his management ability to be evaluated.
After joining Daewoong Pharmaceutical, CEO Chang-jae Lee is a marketing project manager (PM), sales manager, and then promoted to the youngest marketing executive. In addition, he was promoted to Vice President in 2020 after serving as the head of the ETC sales and marketing division and the business management division. After that, he was promoted to vice president in recognition of his achievements and abilities, and took the position of president only two years later.
‘Nabota’ begins licensing process in China… Estimated review period of about 1 year
If commercialization is successful, rapid growth is expected … Jeon Seung-ho’s role as president is important
Daewoong Pharmaceutical submitted clinical data and a biological drug license application (BLA) for its botulinum toxin drug ‘Nabota’ to the National Drug Administration (NMPA) of China on December 31 last year. It has been about five and a half years since the company entered the local market and started the licensing process.
Daewoong Pharmaceutical announced its entry into the local botulinum toxin market by applying for a phase 3 clinical trial for ‘Nabota’ to the then-China Food and Drug Administration (CFDA, now NMPA) in June 2016.
In January 2018, about a year and a half after this, Daewoong Pharmaceutical received approval for a clinical trial plan (CTA) from the CFDA and began preparations for a full-scale clinical trial, but the CTA was abruptly withdrawn in October of the same year. The reason was the change of the ‘Nabota’ production plant.
At that time, Daewoong Pharmaceutical said, “At the time of submitting the CTA to the CFDA in China, we applied for (clinical testing) with the production of the first plant. It was decided to change the production site to the second factory, which has more than 9 times the production capacity compared to the previous year.”
Daewoong Pharmaceutical submitted the CTA again in December 2018, two months later, and received CFDA approval in March 2019, the following year.
After that, the process went smoothly. In December 2019, a full-scale phase 3 clinical trial started, and the trial was completed in July of last year, after about a year and eight months, and the data were organized.
Clinical trials and commercialization were delayed for more than a year due to the voluntary withdrawal of CTA, but considering the growth and potential of the Chinese botulinum toxin market, it is evaluated that Nabota’s local competitiveness is sufficient. This can be seen to some extent through Hugel, which successfully entered the Chinese market before Daewoong Pharmaceutical.
In October 2020, Hugel received approval as a large-selling product for its botulinum toxin preparation ‘Retivo’ in China and launched the product in February last year. Hugel does not disclose the sales of ‘Retivo’ in China, but it is known that the current quarterly sales amount to tens of billions of won. This is interpreted to mean that the local botulinum toxin formulation market is growing explosively, and there is a large demand for Korean products.
In fact, China is considered a market with abundant potential as the experience rate of botulinum toxin preparations is still only around 1%. Goldman Sachs, the largest investment bank in the United States, predicted that the Chinese botulinum toxin formulation market, which was worth $672 million (about 800 billion won) in 2018, will expand to $1.555 billion (about 1.8 trillion won) by 2025. looked forward
‘Retivo’ submitted a BLA to the NMPA in China in April 2019 and obtained approval in October of last year, about one year and six months later. Considering that China was at the time when the Corona 19 situation was the most severe and there were many administrative delays, ‘Nabota’ is expected to be able to obtain Chinese approval by the end of this year or the first half of next year at the latest.
As Hugel’s ‘Retivo’ has been on a rapid growth trajectory since its launch in China, the industry is predicting that if ‘Nabota’ succeeds in commercialization, sales will occur quickly.
However, the role of CEO Jeon Seung-ho, an expert in overseas business, is important for local approval and release to occur without problems. This is because China, a communist country, has a strong government influence due to its political nature, so the drug approval process is more complicated than in other countries and there are many variables.
Since joining Daewoong Pharmaceutical, CEO Jeon Seung-ho has served as a licensing team leader, global strategy team leader, global marketing TF team leader, and global business division manager, and is currently leading Nabota’s global expansion. Obtaining US approval and launching ‘Jubo’ (‘Nabota’ US product name) is also considered one of the former president’s achievements.
Jeon Seung-ho, who was appointed as the CEO of Daewoong Pharmaceutical in 2018, succeeded in reappointing this year in recognition of his achievements. In the midst of this, if Nabota’s entry into China is successfully completed, the position of the former president in the company is expected to be further consolidated.
An industry official said, “The domestic approval of ‘Pexuclu’ and the application for Chinese approval of ‘Nabota’ will be of great strength to CEOs Jeon Seung-ho and Lee Chang-jae, who are working together for the first time this year, and will serve as a test bed for performance. As they are considered as the next generation of ‘cash cows’, both managers are expected to exert their utmost efforts to achieve results in their respective fields,” he said.
Meanwhile, Daewoong Pharmaceutical changed from the system of co-CEOs Yoon Jae-chun and Jeon Seung-ho to Jeon Seung-ho and Lee Chang-jae through regular executive personnel appointments in 2022. Former CEO Yoon Jae-chun was promoted to vice-chairman of Daewoong, a holding company.
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