If 90% of business is just showing up, these K-biopharm firms nail it

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If 90% of business is just showing up, these K-biopharm firms nail it

SAN FRANCISCO - While Samsung BioLogics and Celltrion graced the Grand Ballroom at the 38th annual J.P. Morgan Healthcare Conference, other Korean companies labored to get their message out on lesser platforms at the Westin St. Francis hotel in San Francisco.

They were relegated to the Emerging Markets Track and made presentations in smallest room utilized by the conference organizers, way up on the 32nd floor.

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Genexine Chairman Sung Young-chul presents the company’s research and development strategies Wednesday during the 38th J.P. Morgan Healthcare Conference held in San Francisco. The Korean biotech company announced its midterm results for the Phase 2 clinical trial of its treatment for cervical cancer using HPV therapeutic DNA vaccines in combination with Keytruda. [KO JUN-TAE]

Despite the limited exposure, they did their best to explain their research and development (R&D) strategies and future initiatives before investors. Genexine, Hugel, LG Chem Life Sciences, Daewoong Pharmaceutical and Hanmi Pharmaceutical made it clear that they have big plans and ambitions.

For some, just being there was important.

“It is the first time for us to present at the J.P. Morgan Healthcare Conference,” said Hugel CEO Sohn Ji-hoon. “It gives us the opportunity to present our global strategies.”

For the most part, they updated investors on progress being made on pipeline development. They emphasized that they are not dependent on just one or two therapies.

Genexine, which presented early in the morning, mainly focused on presenting the midterm Phase 2 clinical trial results for its treatment for cervical cancer using HPV therapeutic DNA vaccines in combination with Keytruda.

Chairman Sung Young-chul, who has been leading the company since November, said the results were successful and that the company is well on its way to earning conditional commercialization approval from the Ministry of Food and Drug Safety within 2022.

Conditional approvals are usually granted based on the results of Phase 2 clinical trials for treatments targeting serious and rare disorders. Those receiving such approvals can start selling the treatment once they begin Phase 3 clinical trials.

LG Chem Life Sciences President Son Jee-woong announced during his session that the company has expanded the number of new drug development projects to 40 from 30. The life sciences division of LG Chem spent a total of 165 billion won (142 million) on R&D last year.

The company is expanding its portfolio to stay current with the global trend of diversifying market strategies for future growth. It is mainly concentrated on developing treatments for cancer, diabetes, gastrointestinal diseases and immune system-related disorders. It is also pursuing open innovation and looking for more partners.

Son said the company’s progress on Phase 2 clinical trials for its gout treatment and chronic inflammation therapy have been positive thus far.

Daewoong Pharmaceutical sees 2020 as a year to realize value from the R&D investments it has made over the years.

The company announced that it is seeking to concentrate on introducing its Fexuprazan gastroesophageal reflux disease treatment to the global markets. The company is awaiting approval for the therapy from Korea’s Drug Safety Ministry after completing Phase 3 clinical trials last year. Daewoong Pharmaceutical CEO Jeon Seng-ho said the company will work to kick off clinical trials in other countries this year and eventually entered the global 40 trillion won market.

The company also used its time slot to introduce additional business initiatives for its botulinum toxin products. Daewoong Pharmaceutical has gained some recognition on a global scale due to the strong market entrance of its Nabota botulinum toxin product.

Jeon said the company is targeting the therapeutic market in addition to the aesthetic market. Daewoong Pharmaceutical has been working with AEON Biopharma since last year to kick off clinical trials and get approval for the use of botulinum toxin products for therapeutic purposes in the United States.

Hugel, which took the stage at the J.P. Morgan Healthcare Conference for the first time in the company’s history, said it is expecting to start globalization of its botulinum toxin product before June. Hugel CEO Sohn said the company is expected to earn approval for the product from the Chinese health authorities by June at the latest and is aiming to receive the same from the U.S. Food and Drug Administration (FDA) between late 2021 and early 2022.

He added that the FDA decided to start evaluation for clinical trials of Botulax from Hugel without additional documentation. Hugel has been projecting final FDA approval between late 2022 and early 2023.

Hanmi Pharmaceutical said its focus remains on approvals for eight of its key new drugs. CEO Kwon Se-chang is especially focused on getting trials and the approval processes going for nonalcoholic steatohepatitis treatment HM15211 and anti-obesity drugs HM12525A and HM15136.

Development rights were returned to Hanmi by Beerse, a Belgium-based subsidiary of Johnson & Johnson, of New Brunswick, New Jersey, in July last year, as Phase 2 clinical trials did not yield satisfactory results.

After a series of setbacks in developing new drugs during the first half of last year, and a more than 50 percent drop in the stock price in a year, the company has been working to sign more drug development deals with global counterparts.

Other Korean companies updated reporters on their progress during the conference despite not making formal presentations.

SK Biopharmaceuticals, which in November last year was the first Korean company to earn an FDA approval on its own, told reporters Wednesday that it will launch one new drug every two years to keep the momentum going.

Xcopri, a tablet treatment for partial-onset seizures in adults with epilepsy, is expected to be offered by the end of the second quarter, according to SK Biopharmaceuticals CEO Cho Jeong-woo, adding that it has already hired the needed 110 sales representatives to market the treatment in the United States.

The company has already earned approval to start Phase 1 clinical trials for another treatment for the same disorder from the FDA in December and is on track to develop an anticancer therapy.

Sunosi, an SK Biopharmaceuticals treatment for excessive daytime sleepiness, which was tech transferred to Jazz Pharmaceuticals, is expected to earn sales approval from the European Medicines Agency this month. Sunosi will hit the German market mid-2020 and be taken to the French and British markets next year.

BY KO JUN-TAE [ko.juntae@joongang.co.kr]

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