- by Son, Hyung-Min Feb 29, 2024 06:03am
The achievements made by the pharmaceutical and bio-industry companies in Korea in developing targeted antitumor therapies are being introduced at academic conferences overseas. iLeadBMS and PharosiBio have announced positive preclinical study results, and have received the green light to enter main clinical trials.
The ESMO Targeted Anticancer Therapies Congress 2024 was held in Paris, France, for 3 days from February 26. The European Society for Medical Oncology, one of the world's three major oncology societies, organizes the congress every year to showcase promising new targets and candidates.
On the 26th, iLeadBMS, a drug developer subsidiary of Ildong Pharmaceutical, presented clinical trial results on its IL2106, a molecular glue (targeted protein degradation, TPD), through a poster presentation. Founded in December 2020, iLeadBMS is a bioventure that develops new drugs in the field of small molecules. Ildong Pharmaceutical became the company’s largest shareholder in July 2021.
The TPD molecule being developed by iLeadBMS has a mechanism of action that degrades proteins that cause cancer and eliminates the target itself. Targeted anticancer drugs inhibit tumor growth by acting on the target protein, but TPDs offer an advantage as they target the cause of the disease.
Although no TPD product has been commercialized yet, pharmaceutical companies that have seen the promise of the technology have been continuously joining in on the challenge. In addition to Ildong Pharmaceutical, Novo Nordisk and Daewoong Pharmaceutical have entered the development stage.
iLeadBMS targets CDK12, a protein that regulates the expression of genes related to cancer. The CDK12 protein is known to be expressed in several solid tumors, including breast and gastric cancers.
In a preclinical trial, IL2106 potently inhibited cells expressing triple-negative breast cancer and HER2-negative gastric cancer through targeted protein degradation. IL6-110 was particularly successful in significantly reducing cyclin K levels in HCC70 cells that cause triple-negative breast cancer.
In a study conducted on mouse models, IL2106 demonstrated a favorable pharmacodynamic (PK) profile using a single oral dose.
The team concluded, "These findings can serve as evidence that molecular glues could serve as a novel CDK12/13 inhibitor.”
On the 26th, PharosiBio also announced through a poster presentation that it had confirmed the efficacy of its colorectal cancer drug candidate, PHI-501, in a preclinical trial. PHI-501 is a bispecific antibody that targets pan-RAF and DDR1 (Discoidin Domain Receptor 1). By targeting the two biomarkers, PharosiBio expects its candidate to show efficacy in inhibiting cancer cell growth and metastasis.
The preclinical trial was conducted on the mouse in vivo model to confirm PHI-501’s mechanism of action as monotherapy, on whether it can overcome resistance to BRAF inhibitors while showing antitumor effects.
Results showed that PHI-501 suppressed tumor growth in a colon cancer xenograft model with BRAF or KRAS mutations.
More specifically, PHI-501 showed 96% tumor suppression in the BRAF xenograft model and 83.3% tumor suppression in the KRAS xenograft model. PHI-501 also suppressed tumor growth by 76.1% in a model that showed resistance to the recently approved colorectal cancer drug Vitrakvi by Ono Pharmaceutical.
Based on the positive results found in preclinical trial results, PharosiBio plans to initiate clinical trials to confirm the efficacy of PHI-501.
- Hanmi Pharm ‘confirms the effect of SERM+Vitamin D combo’
- by Son, Hyung-Min Feb 29, 2024 06:03am
Hanmi Pharmaceutical announced on the 27th that the results of big data-based research on 'SERM+Vitamin D combination drugs', including its own ‘RaboneD’, were published in the SCI-level international journal, 'Osteoporosis International'.
RaboneD is an osteoporosis treatment developed by Hanmi Pharmaceutical that combines vitamin D with the SERM class raloxifene.
The study compared the efficacy of selective estrogen receptor modulator (SERM) + vitamin D combination and SERM alone in 2,885 patients diagnosed with osteoporosis using insurance claims data from the National Health Insurance Service from 2017 to 2019.
Sang-Min Kim, Professor of Orthopedic Surgery at Korea University College of Medicine Guro Hospital, Seong-Eun Byun, Professor of Orthopaedic Surgery, CHA Bundang Medical Center, and Hanmi Pharm’s data science team participated in the study.
Study results showed that the SERM+Vitamin D combination significantly lowered the risk of osteoporotic fractures by approximately 23% compared with SERM alone, and the combination reduced the risk of hip fracture by approximately 75% compared with SERM alone.
This is the first real-world, data-driven study to analyze the fracture reduction effect of a SERM+vitamin D combination compared with SERM alone. The results showed that the SERM+Vitamin D combination was effective in reducing the risk of hip fracture as well as osteoporotic fractures compared to SERM alone.
Professor Sang-Min Kim, said, "We found that the risk of osteoporotic fracture was significantly lower in the SERM+Vitamin D administered group compared with the monotherapy group in women with osteoporosis aged 50 years and older in Korea. The results suggest that the SERM+Vitamin D combination may be a viable option for postmenopausal women with a relatively low fracture risk.”
Professor Seong-Eun Byun, said, “SERM class osteoporosis treatments not only improve bone density and lipid profiles, but also act like antiestrogen in the uterus and breast, so there is less concern about the risk of endometrial and breast cancer. As Vitamin D is an important factor that controls the whole body calcium homeostasis and is known to be necessary for bone health, several guidelines recommend adequate intake of vitamin D for patients with osteoporosis."
An Hanmi Pharmaceutical official said, "As a typical chronic disease, the number of osteoporotic fractures has been continuously increasing with Korea’s entry into a super-aged society. Therefore, we expect the results of this study to broaden the treatment options for doctors and patients.”
- NA Opp party in unison say ‘it's time for INN prescribing'
- by Kim JiEun Feb 29, 2024 06:03am
- Opposition lawmakers unanimously voiced the need to introduce International Nonproprietary Names (INN) prescribing and the resolution of the unstable drug supply and demand.
The National Assembly representatives who attended the 70th Regular General Assembly of the Korean Pharmaceutical Association Delegates that was held at The K Hotel in Seoul on the 28th pledged their active support in resolving the pending issues and policies that remain in Korea’s pharmaceutical affairs.
Speaking at the event, Rep. Ihk-pyo Hong, the floor leader of the Democratic Party of Korea, said, "International conflicts are even affecting the medicines I take. They have disrupted the global supply chain and affected the supply of medicines. The government needs to come up with a solution to resolve the issue of this unstable drug supply."
Rep. Ihk-pyo Hong added, “We need to institutionalize and legislate INN prescribing. The concerns in health insurance finances caused by original drugs is an international issue. We need to make efforts to institutionalize INN prescribing."
"The pilot project for non-face-to-face medical treatment is a major topic these days. A public electronic prescription system should be established in the process of institutionalizing non-face-to-face treatment to minimize side effects related to the current prescription transmission.
Rep. Min-Seok Kim, a Democratic Party lawmaker (member of the Health and Welfare Committee), said, "It is problematic that the pilot project for non-face-to-face treatment was implemented in the name of deregulation. It is urgent to institutionalize a public electronic prescription delivery system. I have INN prescribing written down an agenda that needs legislation. We all know that it is a main issue that needs resolution for medical order and publicity in our society.”
Rep. Min-seok Kim added, “INN prescribing is an issue that should be approached through a social agreement, and I hope the issue is presented for the first time in the next National Assembly. We need to discuss the working environment and grounds for young pharmacists. They would also want to work under a fair order. We will work to create that fair order with pharmacists who have served on the side of the people."
Rep Sang-hee Kim, another member of the Democratic Party of Korea, said, "In no case should the public have difficulty buying medicine at pharmacies due to a lack of medicine. It is so difficult to restore medical school admissions to the number that was reduced after negotiation with doctors during the separation of prescribing and dispensing. Also, the Korean medicine pharmacist system was created as a result of the Korean medicine dispute. Such side effects of wrong policies are difficult to resolve and lead to public burden. I am grateful to the pharmacists for their participation in putting the people first."
- Roche Korea appoints Ezat Azem as new CEO
- by Eo, Yun-Ho Feb 29, 2024 06:03am
Roche Korea is welcoming its new CEO, who will take up the position after a two-month vacancy.
According to an interview, Roche Korea recently appointed Ezat Azem as new CEO.
Before his appointment in Korea, Ezat Azem was a General Manager in Roche’s Greece subsidiary. Ezat Azem joined Roche’s Israel subsidiary in 1997 and worked in the marketing business unit. Later, he headed the subsidiaries in Slovenia and Greece.
Ezat Azem has a background in medical training, having graduated from The Hebrew University of Jerusalem Medical School. Later, he completed an executive MBA from Tel Aviv University.
Meanwhile, former Roche Korea CEO Nic Horridge retired in 2023 and has been appointed head of the Australian subsidiary.
Nic Horridge was appointed as the head of Roche Korea in October 2018 and led the corporation for approximately five years. While he was in office, Nic Horridge’s significant achievements included the expansion of the anticancer immunotherapy ‘Tecentriq (atezolizumab)’ to include first-line treatment of lung cancer. Additionally, he facilitated new listings of ‘Evrysdi (risdiplam)‘ for spinal muscular atrophy, ‘Vabysmo (faricimab)’ for eye diseases, and ‘Rozlytrek (entrectinib),’ a tumor-agnostic drug.
- Saxenda and Qsymia take up 57% of the obesity market share
- by Chon, Seung-Hyun Feb 28, 2024 10:35am
- Last year, Korea’s obesity drug market size reached its largest size in history. It broke the record in 2019, and since then, the market size expanded for five consecutive years. Saxenda and Qsymia account for 60 % of the total market share. Meanwhile, sales of previous obesity drugs, such as psychotropic drugs, are declining, further polarizing the market. As blockbuster drugs gaining popularity overseas are nearing launch in Korea, the dynamics of the Korean obesity drug market are expected to change in the future.
The market for obesity drugs was 178 billion won last year, up 1.3% from the previous year, according to a pharmaceutical market research company IQVIA on the 29th.
The market for obesity drugs reached 134.1 billion won in 2019, hitting a new record in ten years, and changed its record for four consecutive years. The market has been growing rapidly every year, with an increase of 83.9% over five years since it made 96.8 billion won in 2018.
The introduction of Saxenda and Qsymia recently has expanded the market for obesity drugs.
Last year, Saxenda recorded sales of 66.8 billion won, marking a 13.4% increase compared to the previous year, achieving a new record for two consecutive years. After recording sales of 42.6 billion won in 2019, Saxenda slowed in sales in 2020 and 2021, with 36.8 billion won and 36.2 billion won, respectively. It is analyzed that due to limited outdoor activities during the initial spread of Covid-19, the interest in obesity drugs may have decreased.
However, it has been noted that the demand for Saxenda rose as many people gained weight due to reduced outdoor activities during the Covid-19 pandemic since 2020, and as outdoor activities resumed, the demand for Saxenda continued to increase. In comparison to the sales in 2020, Saxenda's sales in 2022 increased by 84.4% over the course of two years.
Saxenda, launched in Korea in 2018, is the first glucagon-like peptide-1 (GLP-1) agonist medication for obesity. It contains the same ingredient as Victoza (ingredient: liraglutide), which is prescribed to patients with type 2 diabetes, but with different methods of administration and dosages.
Saxenda became the top-selling drug in the market after recording sales of 42.6 billion won in 2019, just after its launch, and maintained the place for five consecutive years.
The mechanism of action of Saxenda was designed similarly to the body’s GLP-1, leading to the suppression of appetite and weight loss. It gained popularity with the perception that it is relatively safer than existing weight-loss drugs.
According to estimates, Saxenda took up a 37.5% market share of the obesity market last year. While Saxenda’s market share grew significantly from 7.8% in 2018 to 31.8% in 2019, it slowed down in 2020 and 2021, holding 25.8% and 25.2%, respectively. However, in 2022, Saxenda’s market share increased to over 30% and continued to grow last year.
Alvogen Korea’s Qsymia has been gaining popularity recently. Qsymia reached sales of 35.5 billion won last year, an increase of 18.0 % compared to the previous year. In two years since 2021, when it made 26.2 billion won, the sales expanded by 35.4%.
Qsymia, a combination drug of “phentermine’ and ‘topiramate,’ was launched in late 2019. Alvogen Korea acquired the sales rights for Qsymia in Korea from Vivus of the United States in 2017. Alvogen initiated domestic marketing through a joint sales agreement with Chong Kun Dang.
Despite oral administration, Qsymia has a relatively small amount of psychotropic drug ingredients, and it has the advantage that it can be prescribed for an extended period. Alvogen Korea's extensive sales networks in the domestic obesity market, gained from its previous experience selling Furing and Furimin, synergized with Chong Kun Dang's business power to penetrate the market with Qsymia rapidly.
Last year, Qsymia's market share in the obesity treatment market increased by 2.8% compared to the previous year, reaching 19.9%. The combined market share of Saxenda and Qsymia accounted for 57.5% of the total obesity market last year. The market share of Saxenda and Qsymia increased by 16.0% over two years, from 41.5% in 2020, significantly enhancing their market influence.
In contrast, existing obesity drugs, excluding Saxenda and Qsymia, showed weakness overall. Sales of obesity drugs, excluding Saxenda and Qsymia, decreased by 12.7% to 757 billion won compared to the previous year.
Daewoong Pharmaceutical's Dietamin saw a decrease in sales to 7 billion won last year, down 11.5% from the previous year. Huons' Hutermin recorded sales of 4.3 billion won, a 10.7% decrease from the prior year. The market share of existing obesity treatments, excluding Saxenda and Qsymia, was 68.2% in 2019 but decreased to 42.5% last year.
The industry anticipates that the emergence of overseas validated blockbuster treatments for obesity would bring significant changes in market dynamics.
Last April, the Ministry of Food and Drug Safety (MFDS) approved Novo Nordisk's Wegovy. Wegovy is a GLP-1 agonist in the same class as Saxenda. Novo Nordisk improved upon Saxenda, administered once daily, by making Wegovy a once-weekly injection. Since its release in the U.S. market, Wegovy's demand has surged to the point of shortages, with even Ozempic, a diabetes treatment with the same ingredient and usage, experiencing stockouts due to its high popularity.
Eli Lilly's Mounjaro received approval from the MFDS in June last year. Mounjaro is a next-generation GLP-1 agonist that activates GLP-1 and GIP receptors with a once-weekly dose. It was approved as a treatment for type 2 diabetes and is expected to secure indications for obesity treatment in the future. Since its approval in the United States last year, Mounjaro generated sales of 2 trillion won in the first half of this year. With Mounjaro's approval as an obesity treatment, it is expected to bring significant changes in the obesity drug market alongside Wegovy.
- KRPIA appoints Sanofi CEO Kay Bae as new chair
- by Feb 28, 2024 05:50am
The Korean Research-based Pharmaceutical Industry Association (KRPIA) announced on the 23rd that it has appointed Kay Bae (Bae Kyung-eun), Country Lead of Sanofi-Aventis Korea, as the 15th chair of KRPIA.
Bae served on the KRPIA board of directors in September 2013, and she has been a member of the vice-chair body, contributing to the growth of KRPIA.
Bae graduated from the College of Pharmacy at Seoul National University and received a master’s degree in global management from Aalto University School of Business.
Bae gained diverse experiences in the field, including positions as Global Head of Business Units, Head of Anticancer Drugs and Prescription Medicines, and CEO at global pharmaceutical companies since 1994.
For over ten years, Bae served as the head of Sanofi-Aventis Korea, where she is currently the CEO. She led the unification of independent business units, Sanofi Pasteur, a subsidiary dedicated to producing vaccines, and Sanofi Genzyme, a part of the Specialty Care franchise, into a single brand.
Before becoming CEO of Sanfofi-Aventis Korea and Genzyme Korea, Bae worked at Novartis Korea and Novartis Unites States. Since September 2022, Bae has been serving as the chairperson of the Healthcare Committee at the European Chamber of Commerce in Korea (ECCK).
Bae is known for having a profound understanding of the pharmaceutical industry and the Korean systems and policies while demonstrating strong leadership skills.
“We will strive to provide rapid and broadened treatment benefits of innovative new drugs to patients in Korea amid the rapidly evolving healthcare and medical industry,” Bae said. “To promote innovative development in the domestic pharmaceutical and biotechnology industry, we plan to collaborate with other domestic companies by strengthening our open innovation platform,” Bae added.
The KRPIA has announced the appointment of new vice-chairs along with a new chairperson.
KRPIA’s vice-chairs are △Jae (Byungjae) Yoo of Novartis Korea, △Hye Young Lee of BMS Pharmaceutical Korea, and △Dong-Wook Oh of Pfizer Korea. A new board of directors was elected through a voting process in mid-January last year: △Maurizio Borgatta of GSK Korea △Jaeyeon Choi of Gilead Sciences Korea, △Christoph Hamann of Merck Korea, △Ji-young Sohn of Moderna Korea, △JinA Lee of Bayer Korea, △Sang Kyung Noh of Amgen Korea, △Junil Kim of Astellas Pharma Korea, △Soyoung Kang of AbbVie Korea, and △Albert Kim of MSD Korea.