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- 2026-05-04 18:09:02
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- K-bio, R&D global competitiveness will be put to the test
- by Son, Hyung-Min Mar 22, 2024 06:09am
- The American Association for Cancer Research annual meeting (AACR 2024) will be held April 5-10 in San Diego. The Korean pharmaceutical industry will showcase its new candidate products entering late-stage clinical trials or aiming to export technology on platforms, testing their global competitiveness. The spotlight is on these new candidate products, particularly the trending bispecific antibodies and antibody-drug conjugate (ADC), to identify which ones stand out from the rest. Yuhan, Hanmi Pharmaceutical, ABL Bio, and LegoChem Biosciences announced they are prepared to present the clinical trial results at the conference. According to industry sources on the 19th, the American Association for Cancer Research annual meeting 2024 (AACR 2024) will be held April 5-10 in San Diego, United States. The AACR is one of the world’s three cancer conferences, next to the European Society for Medical Oncology (ESMO). During the conference, early-stage clinical results of new candidate cancer drugs, including findings from preclinical and phase 1 trials, are typically presented. Korean pharmaceutical drug discovery actively pursues the development of ‘bispecific antibodies,‘ which simultaneously target two mutations At this year's AACR 2024, the Korean companies will present clinical results of candidate bispecific antibodies with novel mechanisms. Bispecific antibodies have clinical advantages over monoclonal antibodies, as they have additional specific antigen-binding sites. Yuhan will unveil two preclinical research results of bispecific antibodies in cancer immunotherapy, which the company is jointly developing with a bioventure company in South Korea. Yuhan’s new candidate product to be presented at the meeting is YH41723. YH41723, cancer immunotherapy under joint development by Yuhan and ImmuneOnsia, targets PD-L1 and TIGIT. Yuhan plans to maximize the drug's effect by targeting both TIGIT (T-cell iMMunoreceptor with immunoglobulin and ITIM domain) and PDL-1, which is currently targeted by commercialized cancer immunotherapy such as Keytruda and Opdivo. In addition to Yuhan Pharmaceuticals, global pharmaceutical companies such as Roche, Merck, Novartis, and Gilead are also developing anti-cancer drugs targeting TIGIT. Additionally, during a poster session, Yuhan will present the preclinical results of YH32367, which is under joint development with ABL Bio. YH32367 targets HER2 and 41BB proteins expressed in major solid cancers. It has been reported that reducing 41BB toxicity can prevent long-term cancer recurrence because 41BB is activated only nearby PD-L1-expressing cancer cells. Hanmi Pharmaceutical will present preclinical results of BH3120, which targets PD-L1 and 41BB. BH3120 incorporates Hanmi's platform technology Pentambody, a next-generation bispecific antibody platform that activates immune cells while selectively attacking target cancer cells. Results on the anticancer synergy and safety profile of PDL-1 inhibitors in combination therapy will be presented at the conference. Beijing Hanmi Pharmaceutical is currently conducting phase 1 clinical trials of BH3120 as a monotherapy. Additionally, Hanmi Pharmaceutical will present research results of the next-generation EZH1/2 bispecific inhibitor, HM97662. Selective inhibition of EZH2 is known to induce resistance by activating EZH1. Based on the assumption that bispecific inhibition of EZH1 and EZH2 may be more effective than EZH2 inhibition alone, Hanmi Pharmaceutical has developed HM97662. ABL Bio will participate in poster sessions to present the preclinical results of its new bispecific antibody immunotherapy candidates, ABL112 and ABL407. These two candidate pipelines, featuring the 41BB-based bispecific antibody platform Grabody-T, will be presented for the first time at AACR 2024 next month. ABL112 targets TIGIT. ABL407 targets LILRB4, which is overexpressed in immunosuppressive tumor-associated myeloid cells. Shaperon will present the research results of Papiliximab, a nano-body bispecific antibody that simultaneously inhibits the immune checkpoint and innate immune checkpoint proteins. The company plans to reveal how they can prevent cancer cells from evading the immune system's response by simultaneously targeting PD-L1 and the innate immune checkpoint ligand CD47. Papiliximab is known for not causing hemolysis even at high concentrations, thereby avoiding the side effects of conventional CD47 antibodies. LegoChem Biosciences will showcase the preclinical results of ADC bispecific antibody ‘LCB36’ LegoChem Biosciences, specializing in antibody-drug conjugates (ADCs) discovery, will present the preclinical results of its ADC bispecific antibody LCB36 for the first time at the conference. LCB36 targets CD20 and CD22. LCB36 is the first to target CD20 and CD22 simultaneously, while monoclonal antibodies targeting CD20 or CD22 and bispecific antibodies targeting CD20 and CD3 have been developed CD20 and CD22 are known to be expressed in blood cancers, and LegoChem Biosciences is developing LCB36 as a new drug targeting B-cell lymphoma. LegoChem Biosciences plans to showcase the drug tolerance and safety model acquired from a mouse model study. Additionally, LegoChem Biosciences plans to showcase the research outcomes of ADC LCB02A, which targets claudin 18.2. Claudin 18.2 is a protein overexpressed in stomach and esophagus cancers, an emerging target that ADC drug discovery focuses on. LegoChem Biosciences will also showcase the preclinical results of LCB84, an ADC targeting TROP2. LCB84 is a new drug candidate that achieved a successful technology export to Johnson & Johnson's subsidiary Janssen in the United States in December last year, amounting to $1.7 billion (approximately KRW 2.24 trillion). In preclinical studies, LCB84 demonstrated efficacy in solid tumors not responding to topoisomerase enzymes-based TROP2 ADC payloads. Major ADCs like Enhertu (trastuzumab deruxtecan) incorporate the technology of topoisomerase enzymes. TROP2 functions as a calcium signal transducer in cells, regulating cell proliferation and survival. Although this protein is found in normal cells, it is often overexpressed in cancer cells, leading to drug resistance. The TROP2 biomarker is mainly found in breast cancer, non-small cell lung cancer, colorectal cancer, and other solid tumors. Companies like LegoChem Biosciences are targeting major solid tumors in their clinical trials. The only successful commercialization using a similar mechanism has been Gilead's Trodelvy (sacituzumab govitecan).
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- Lotte Biologics’ sales amount to KRW 228.6 billion
- by Kim, Jin-Gu Mar 22, 2024 06:09am
- Lotte Biologics. Lotte Biologics recorded sales of KRW 228.6 billion last year. As the Syracuse manufacturing plant in the United States went into full-scale production, sales of KRW 83.1 billion in the first half of the year expanded to KRW 145.6 billion in the second half of the year. The analysis indicates that Lotte Biologics’ Contract development and manufacturing organization (CDMO) business is on the right track. According to the Financial Supervisory Service on the 23rd, Lotte Biologics' sales for last year amounted to KRW 228.6 billion. The company, launched in May 2022, began generating significant revenue last year. Sales for the first quarter were KRW 20.7 billion, KRW 62.3 billion for the second quarter, KRW 89.8 billion for the third quarter, and KRW 55.8 billion for the fourth quarter. The net income for the year amounts to KRW 56.7 billion. In 2022, the company turned around from a loss of KRW 17.7 billion. Lotte Biologics' revenue is expected to derive most of its revenue from its CDMO business in the United States. In May 2022, Lotte Biologics signed a contract with BMS to acquire a biopharmaceutical production plant in Syracuse, U.S., for $160 million (approximately KRW 220 billion). This plant can produce raw materials for antibody medicines at an annual scale of 35,000 liters. The acquisition process was completed as of December 31, 2022. Starting from January 1, last year, the plant commenced full-scale production. Lotte Biologics inherited the existing CDMO contracts as part of acquiring the BMS plant. The company will commit to produce pharmaceuticals manufactured by BMS for the next three years after acquiring the plant. According to this contract, last year, the Syracuse plant reportedly produced BMS's immune checkpoint inhibitors 'Opdivo' and 'Yervoy,' immunosuppressants for kidney transplantation 'NeuroLex,' and multiple myeloma treatment 'Empliciti.' Lotte Biologics’ Syracuse manufacturing plant in the United States. The company began generating significant revenue last year. Securing new clients has remained a challenge for the company. Last year's revenue was mostly derived from inheriting BMS's CDMO contract; thus, there were almost no new orders. Considering the three-year contract period, it is analyzed that the company needs to secure new clients within the next two years to meet the target annual revenue of KRW 1.5 trillion by 2030. Lotte Biologics' focus on global events such as the BIO International Convention, CPhI Global event, and the JP Morgan Healthcare Conference aligns with this strategy. Lotte Biologics has announced its participation in BIO International Convention, which will be held in San Diego in June this year. For the third consecutive year since 2022, the company will operate a booth, emphasizing its distinctive capabilities by showcasing the company’s manufacturing technology, process development services, quality systems, and plans for establishing a domestic mega plant. During last year's conference, the company set up meeting tables and private meeting rooms within the booth, facilitating partnering with over 30 global pharmaceutical companies and small to medium-sized biotech firms interested in biopharmaceuticals CDMO. This year, they plan to continue focusing on securing CDMO contracts with global pharmaceutical companies through meetings. Lotte Biologics aims to achieve sales of KRW 1.5 trillion by 2030. To accomplish this goal, they are securing domestic production facilities, in addition to expanding CDMO business centered around the Syracuse plant in the United States. In June last year, they signed an MOU with the Incheon Metropolitan City and the Incheon Free Economic Zone Authority to construct a mega plant in Songdo, Incheon. By 2030, the company plans to build three mega plants, each with a capacity of 360,000 liters.
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- Antihistamine sales benefit from end of pandemic and endemic
- by Son, Hyung-Min Mar 22, 2024 06:06am
- Last year, sales of major antihistamines showed a clear recovery, exceeding the level it had made before the pandemic. Sales of antihistamines had plummeted in 2020 and 2021 during the COVID-19 pandemic. The analysis is that the increase in sales is likely due to the rise in allergy patients with the lifted mask mandates and the increase in outdoor activity that followed. According to the market research institution IQIVA on the 21st, sales of the antihistamine Xyzal increased 18% YoY to reach KRW 14.4 billion the past year. Xyzal is a third-generation antihistamine developed by UCB Korea and is the leader in the antihistamine market. Antihistamine drugs block histamine, which is involved in allergic reactions such as hives, redness, and itching. In addition to allergic conditions, they are also used to relieve rhinitis, asthma, and nasal congestion. Because antihistamines work on the central nervous system (CNS), they can cause side effects such as drowsiness and sedation. However, third-generation antihistamines are known to cross the blood-brain barrier (BBB) less frequently than first- and second-generation medications, making them less likely to cause drowsiness. Xyzal’s sales decreased by 17.6% to KRW 9.3 billion in 2020 from KRW 11.3 billion in 2019, but increased again to KRW 9.9 billion in 2020 and then to KRW 12.2 billion in 2022. The industry believes sales of antihistamines will continue to grow along with the increase in the number of allergic rhinitis patients in Korea. According to the Korea Disease Control and Prevention Agency, the rate of physicians’ diagnosis of allergic rhinitis increased from 16.8% in 2012 to 21.2% in 2022. The NHIS data also showed that the number of patients diagnosed with allergic rhinitis increased to 6.01 million in 2022 from less than 5 million in 2021 during the COVID-19 pandemic. Other third-generation antihistamines also saw a resurgence in sales with the end of the pandemic. Handok's Allegra generated sales of KRW 8.1 billion last year, up 10.9% YoY. Allegra is a fexofenadine-based antihistamine developed by Sanofi, and Handok holds domestic rights for the drug in Korea. Allegra’s sales were sluggish in 2020 and 2021, KRW 4.8 billion and KRW 5 billion, respectively, but recovered to KRW 7.3 billion in 2022 and surpassed KRW 8 billion last year. Fexonadine, a same-ingredient drug from Hanmi Pharmaceutical, also saw a 21% increase in sales YoY. Sales of Organon Korea’s Aerius, a desloratadine-based third-generation antihistamine, rose 44.4%. The rebound in sales has led to a series of launches of third-generation antihistamines by domestic drugmakers as well. Samjin Pharm and GC Biopharma also launched their fexofenadine-based allergy treatments this month. first-and-second generation antihistamines also show good sales...Sales of Clarityne sluggish In addition to third-generation antihistamines, sales of first- and second-generation antihistamines also grew in general. UCB Korea’s Zyrtec, a second-generation antihistamine, generated sales of KRW 14.3 billion last year, up 14.4% from KRW 12.5 billion in 2022. Zyrtec has been sold exclusively in Korea by the local drug distributor BeoYoung since last year. In Korea, Zyrtec sold 2.628 million tablets last year. Sales of UCB Korea’s Ucerax, a first-generation antihistamine, reached KRW 1.4 billion, up 55.5% YoY. The company had previously considered withdrawing the marketing authorization of its Ucerax due to insufficient supply, but the company succeeded in resuming supply in 2019 with Yuhan Corp taking over domestic distribution. Sales of Hansol Pharm’s Zeromine soft capsules grew 58.3% compared to 2022. On the other hand, sales of Bayer’s Clarityne and Yungin Pharmaceutical’s Plakon dropped sharply. Clarityne posted sales of KRW 40 million last year, down 60% from the KRW 1 billion in 2022. Clarityne is a second-generation antihistamine developed by Merck, and Bayer acquired its marketing rights in 2014 when it acquired Merck's OTC division. Clarityne's sales fell from KRW 1.1 billion in 2019 to KRW 900 million in 2021, and last year, sales fell to less than KRW 100 million. Bayer Korea explained, "The product has been out of stock since Q1 last year due to a shortage of supply that was unable to meet the high demand, which led to the decline in sales.” Plakon’s sales fell 70% YoY and reached KRW 90 million last year. Before COVID-19, Plakon ‘s sales were in the KRW 2 billion range, but sales have continued to decline. Yungin Pharmaceutical withdrew the product from the Korean market by withdrawing its marketing authorization for the drug. Plakon, which was approved in Korea in 1962, is a first-generation antihistamine containing piprinhydrinate and was subject to clinical reevaluations in 2021. Yungin Pharmaceutical did not submit the reevaluation data and received administrative dispositions - a two-month sales suspension in December of the same year. The company voluntarily withdrew the product in February 2022. Accordingly, Plakon was also removed from the drug shortage prevention list in April 2022.
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- Luxturna prescriptions available for rare retinal disease
- by Eo, Yun-Ho Mar 22, 2024 06:06am
- Novartis Korea’s Luxturna (voretigene neparvovec), a therapy used to treat inherited retinal dystrophy (IRD). Prescriptions for the gene therapy ‘Luxturna,’ which targets only a few patients, are becoming available in South Korea. According to industry sources, Novartis Korea’s Luxturna (voretigene neparvovec), a therapy used to treat inherited retinal dystrophy (IRD), has cleared the Drug Committee (DC) of the tertiary general hospitals, including Samsung Medical Center in Seoul, Seoul National University Hospital, and Severance Hospital. Luxturna was first administered at Samsung Medical Center in Seoul among these hospitals. Luxturna, listed for reimbursement last February, restores function by substituting the RPE65 gene mutation, which is one of the causes of IRD, with a normal gene through a single administration. Essentially, it is a disease-modifying treatment. Since Luxturna is a gene therapy, the number of hospitals prescribing it may not increase significantly. Hospitals that can prescribe Luxturna should screen patients to ensure they receive benefits, given the limited number of patients. Phase 3 clinical trials, including patients with confirmed biallelic RPE65 mutations-associated IRD, demonstrated the efficacy of Luxturna. The clinical results revealed that the patients treated with Luxturna had significantly improved functional vision after one year compared to the comparator group. The 'Multi-Luminance Mobility Test (MLMT) average score, which evaluates the ability to pass various obstacles of different heights in everyday walking environments, was used as the primary endpoint at the one-year treatment assessment. The Luxturna treatment group's score increased by 1.8 points, 1.6 points higher than the control group's 0.2-point increase. Initially, Luxturna applied for reimbursement in September 2021, but no progress was made. In March last year, it was considered for review by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) but failed to establish a reimbursement criterion. After improving its documents, Luxturna completed negotiations for drug pricing in December and was listed for reimbursement in February.
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- "Envlo shows superior effects in diabetic kidney disease"
- by Son, Hyung-Min Mar 21, 2024 05:52am
- Daewoong Pharmaceutical Daewoong Pharmaceutical announced on the 19th that Envlo (ingredient: enavogliflozin), an SGLT-2 class diabetes treatment from the company’s drug discovery, demonstrated superior effects in patients with diabetes compared to dapagliflozin. Based on the clinical results, Envlo has shown superior effects in all four indexes, including ▲glycosylated hemoglobin, ▲fasting glucose, ▲urine glucose-to-creatinine ratio (UGCR), and ▲homeostasis model assessment-insulin resistance (HOMA-IR), compared to dapagliflozin, another SGLT-2 inhibitor. The clinical study evaluated changes in glycosylated hemoglobin and fasting plasma glucose in 470 patients with type 2 diabetes. Based on their kidney functions, the patients were assigned to two groups and were given either Envlo or dapagliflozin for 24 weeks. The study enrolled patients with type 2 diabetes patients who had inadequate glycemic control despite undergoing a combination of metformin and another antihyperglycemic agent or a combination therapy of metformin and gemigliptin (DPP-4 inhibitor). The clinical results demonstrated that Envlo reduced fasting plasma glucose more significantly than dapagliflozin. The Envlo group had fasting plasma glucose of 26.65 mg/dl at week 6 and 28.54 mg/dl at week 24, while the dapagliflozin group had fasting plasma glucose of only 21.54 mg/dl at week 6 and 23.52 mg/dl at week 24. Envlo, a new Korea-made drug, has a superior effect in reducing ‘glucose’ than a global pharmaceutical drug…The results from the study of diabetic kidney disease patients. A significant reduction in glycosylated hemoglobin in the Envlo group was observed, with a decrease of 0.76% at week 6 and 0.94% at week 24. This indicates a nearly 1% reduction in glycosylated hemoglobin over 24 weeks. Dapagliflozin resulted in a reduction of 0.66% at week 6 and 0.77% by 24 weeks. Among the clinical result indexes, the ‘urine glucose-to-creatinine ratio’ (UGCR) particularly stands out. The UGCR measures the ‘glucose’ secretion in urine. The patients administered with Envlo had UGCR of approximately 55g/g from week 6 to week 24. This result is similar to the level seen in diabetic patients with normal kidney function. Daewoong Pharmaceutical anticipates that the new Korea-made drug Envlo will provide an outstanding alternative for diabetic patients with kidney disorders. Currently, patients who have been taking Forxiga are facing finding a new drug because the global pharmaceutical company announced the discontinuation of Forxiga. “It is of particular interest that we provide clinical evidence when diabetic patients require a new drug prescription,” Daewoong Pharmaceutical’s CEO Chang-jae Lee said. “As the clinical result was published in a globally recognized SCIE research paper, we plan to obtain additional evidence to prove Envlo as an alternative solution,” Lee added. The study was published in the SCIE-listed international research paper, ’Cardiovascular Diabetology.’ It was titled ‘Efficacy and safety of enavogliflozin vs. dapagliflozin as add-on therapy in patients with type 2 diabetes mellitus based on renal function: a pooled analysis of two randomized controlled trials.’
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- Haleon Korea declares full independence from GSK
- by Eo, Yun-Ho Mar 21, 2024 05:52am
- The consumer healthcare company Haleon has declared its full independence from GSK. Haleon Korea, the Korean subsidiary of Haleon, announced on the 20th that it has completed the official registration of its business and is embarking on a new journey. The company had been completely spun off from GSK in July 2022 to become a 100% consumer healthcare specialty company. In Korea, the company has been preparing for the change for the past year and a half, including changing the packaging of its products, and has finally finalized the process and has officially launched as Haleon Korea in March 2024. Haleon Korea has been selling 12 leading brands in Korea, including ▲Centrum (multivitamin brand), ▲Sensodyne (toothpaste for sensitive teeth), ▲Parodontax (toothpaste for gum health), ▲Polident (denture cleaning and adhesive brand), ▲Teraflu (cold relief brand), ▲Otrivine (nasal congestion relief brand), and ▲Driclor (hyperhidrosis management brand). Dong-Woo Shin, CEO of Haleon Korea, said, “We will continue to introduce scientifically verified products every year to empower consumers' self-care capabilities and race for the development of the Korean consumer healthcare market.” Haleon was launched in 2015 and 2020 as the combined consumer healthcare business of Novartis and Pfizer, and then GSK, respectively. The name Haleon is a combination of health and strength, inspired by the old English word "Hale," meaning health, and the Greek word "Leon," which is associated with strength.
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- Fintepla gets orphan drug designation for Dravet syndrome
- by Eo, Yun-Ho Mar 21, 2024 05:52am
- UCB 'Fintepla' has been designated as an orphan drug in South Korea for its indication for Dravet syndrome. The Ministry of Food and Drug Safety (MFDS) has announced this in the posting of the Orphan Drug Designation. UCB’s Fintepla (fenfluramine) initially acquired FDA approval for the treatment of rare epilepsy of infancy in 2020. Additionally, in 2022, it added an indication for Lennox-Gastaut syndrome (LGS). Fenfluramine, banned in the United States in 1997, suppresses appetite by increasing serotonin content in the brain. It was discontinued because overuse of the drug led to the stimulation of the central nervous system, damaged heart valves, schizophrenic symptoms, and even death. Fenfluramine is currently prescribed as a low-dose and liquid form for oral administration. Randomized, double-blind, placebo-and comparator-controlled Phase 3 clinical trial, including children and adolescents aged 2 to 18, demonstrated efficacy of fenfluramine. The primary endpoint was a comparison of the monthly convulsive seizure frequency (MCSF). MCSF comparison results show that the frequency of convulsive seizure for a month in the fenfluramine group reduced by 54.0% compared to the placebo. In the fenfluramine group, 54% had a clinically significant reduction in MCSF, compared to 5% in the placebo group. The fenfluramine group had a longer median seizure-free interval than the placebo group (22 days vs. 13 days). The percentage of patients who were seizure-free after an episode was 12% in the fenfluramine group and 0% in the placebo group. Patients treated with fenfluramine had a significant reduction in convulsive seizures compared to the patients treated with a placebo. Notably, the fenfluramine group had a reduction in seizures within three to four weeks and maintained treatment effects over 14 to 15 weeks. Dravet syndrome is a rare disease characterized by tonic-clonic seizures or myoclonic seizures, which cause muscles in the body to contract and relax, during infancy. It has been reported that SCN1A gene mutations are a common cause of the disease.
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- SK Life Science’s sales rise tenfold in 5 years in the US
- by Chon, Seung-Hyun Mar 20, 2024 05:44am
- SK Biopharmaceuticals' U.S.-based subsidiary posted sales of nearly KRW 500 billion last year. The sales of its epilepsy drug cenobamate increased in the U.S., increasing the company’s sales by over tenfold in 5 years. According to the Financial Supervisory Service on Tuesday, SK Life Science’s sales totaled KRW 49.9 billion last year, up 26.5% from the previous year. SK Life Science is a wholly-owned subsidiary of SK Biopharmaceuticals. It is in charge of the U.S. sales of cenobamate, a new drug developed by SK Biopharmaceuticals. Annual sales of SK Life Science (Unit: KRW 100 million, Data: FSS) SK Life Science’s sales have been showing strong growth, up 83.7% in 2 years since posting KRW 267.2 billion in 2021. Its sales have expanded more than tenfold in five years from a mere KRW 47.5 billion it generated in sales in 2018. This is in part due to the surge in sales of its new epilepsy drug cenobamate in the United States. Xcopri, which contains cenobamate, is an epilepsy drug independently developed by SK Biopharmaceuticals and sold in the United States. It is prescribed for the treatment of partial-onset seizures in adults in the U.S. Its mechanism of action relieves seizure symptoms by simultaneously regulating two targets related to excitatory and inhibitory signaling, which are causes of epilepsy. SK Biopharmaceuticals had independently performed the whole course of Xcopri’s development and commercialization from early development to U.S. Food and Drug Administration (FDA) approval. The company received approval for its cenobamate under the brand name ‘Xcopri’ in November 2019, and has been selling the drug through SK Life Science since May 2020. Last year, cenobamate’s U.S. sales reached KRW 270.8 billion, up 60.1% YoY. In 2021, cenobamate posted sales of KRW 78.2 billion, more than tripling in 2 years. SK Life Science has about 150 medical representatives. Epilepsy is a condition that is treated by a small number of focus specialists in the United States. Due to the small number of target physicians, the company was able to sell the drug directly in the U.S. with such a small sales force. SK Life Science’s marketing center, which consists of sales and marketing personnel, has experts with more than 20 years of experience in successfully launching and selling epilepsy treatments and major central nervous system drugs at Johnson & Johnson, UCB, and other leading companies in the U.S. CNS market. Quarterly sales of Xcopri in the US (Unit: KRW 100 million, Data: FSS) With the rise in cenobamate’s sales, SK Life Science’s parent company has also increased its operating expense support. Last year, SK Life Science's revenue included KRW 220 billion in operating expenses paid by its parent company SK Biopharmaceuticals. SK Biopharmaceuticals earned revenue by supplying SK Life Science with cenobamate. The company pays SK Life Science a certain amount of operating expenses each year, which are reflected in SK Life Science's revenue, according to the company. The company said, "The number of prescriptions in December last year, the 44th month of cenobamate’s launch, was about 26,000, which is about 2.2 times the number of prescriptions made in the 44th month by its competitors. We will work to accelerate growth by increasing the number of monthly prescriptions to over 30,000 this year.”
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- Sales of Tagrisso stay strong, Leclaza rises in lung cancer
- by Mar 20, 2024 05:44am
- In the EGFR-positive non-small cell lung cancer (NSCLC) treatment market, Leclaza’s sales growth stood out amid strong sales of Tagrisso. Tagrisso and Leclaza are both third-generation targeted therapies, and the two were approved as a first-line treatment for lung cancer this year and were given the green light to expand sales. Among first- and second-generation targeted therapies, all drugs other than Giotrif posted sluggish sales last year. According to the market research institution IQVIA on the 20th, Tagrisso generated sales of KRW 111 billion last year, up 4.2% YoY. Tagrisso is a third-generation tyrosine kinase inhibitor (TKI) that was developed by AstraZeneca. EGFR-positive lung cancer treatments are categorized into four types: first-generation EGFR TKIs like AstraZeneca's Iressa (gefitinib) and Roche's Tarceva (erlotinib); second-generation EGFR TKIs like Boheringer Ingelheim's Giotrif and Pfizer's Vizimpro (dacomitinib); and third-generation EGFR TKIs like Leclaza (lasertinib) and AstraZeneca's Tagrisso (osimertinib). Sales of Tagrisso, which exceeded the KRW 100 billion mark in sales in 2020, have remained stagnant for 2 years. After reaching KRW 106.5 billion in 2020, the drug posted similar sales in 2021 and 2022. After working to receive reimbursement for the drug as a first-line treatment for years, AstraZeneca received the reimbursement approval this year as a first-line treatment for EGFR-positive lung cancer, and this is also expected to expand sales. Moreover, Tagrisso is also the only third-generation TKI to be approved for use in early-stage lung cancer. In December last year, Tagrisso was approved as an adjuvant therapy for patients with EGFR exon 19 and exon 21 mutated NSCLC after complete resection. In the phase III ADAURA study, Tagrisso was shown to reduce the risk of death by 51% compared to conventional therapy. Powered by the advantages, Tagrisso’s sales are expected to increase further in the coming years. Leclaza posted sales of KRW 22.6 billion last year, up 40.3% YoY. Leclaza, which was approved in Korea in January 2021, was also granted reimbursement the same year. After posting KRW 4.1 billion in sales in Q2, it posted sales of KRW 16 billion the following year, then surpassed KRW 20 billion last year. Leclaza’s approval as a first-line treatment for EGFR-positive NSCLC in July last year is analyzed to have contributed to the rise in sales. Before the approval, patients had to be confirmed to be T790M-positive through an additional tissue test after using a first- or second-generation EGFR TKI to be eligible to use Leclaza with reimbursement. With all 3 TKIs, including Leclaza and Tagrisso, now covered as first-line treatments, physicians and patients will have a full range of first- and third-generation targeted therapies to choose from. Another benefit of Leclaza is its potential for use in combination with Rybrevant. Combination therapies, including Tagrisso plus platinum-based chemotherapy and Rybrevant plus platinum-based chemotherapy, are currently approved by regulatory authorities abroad for the first-line treatment of lung cancer. Combining the use of Leclaza, which targets EGFR-mutated exon 19 and exon 21 deletion, with Rybrevant, which targets exon 20 deletion, has been attracting attention as a viable targeted therapy combination. Currently, the Leclaza + Rybrevant combination is being reviewed for approval in the US as a first-line treatment for lung cancer. Sales of all first-generation EGFR TKIS other than Giotrif decline During the same period, first- and second-generation TKIs saw sluggish growth. Only Giotrif’s sales showed growth, while all others declined. Giotrif generated KRW 27.2 billion in sales last year, up 5.8% from 2022. Since its launch in Korea in 2014, Giotrif has seen a gradual but steady increase in sales. After surpassing the KRW 10 billion mark in sales for the first time in 2017, Giotrif posted sales of KRW 16.6 billion in 2019, KRW 22 billion in 2021, and KRW 25.7 billion in 2022. Giotrif benefited how third-generation TKIs not being used as first-line treatments. On the other hand, Vizimpro’s sales had been sluggish. Vizimpro, which had been released later in 2020, had increased slightly to KRW 1.4 billion in 2021 and KRW 2.8 billion in 2022, but stagnated at KRW 2.7 billion last year. The weakness of Vizympro is in its side effects. In the ARCHER 1050 study, the Phase III trial that became the grounds for its approval, Vizympro showed better efficacy compared to first-generation TKIs, but also a higher rate of adverse events. 60% of patients in the Vizympro arm required dose adjustments due to adverse events. In general, first-generation TKIs are continuing to show declining sales. First, Iressa posted sales of KRW 12.7 billion last year, down 9.2% YoY. Sales have been on a steady decline since 2020 when sales fell below KRW 20 billion (USD 19.6 billion). Iressa posted KRW 16.7 billion in sales in 2021 and KRW 14 billion in 2022. Iressa is known to be a milder cancer drug with fewer side effects among targeted therapy options. As such, it has been used as a priority in patients with relatively poor health. However, sales have been declining with more treatment options becoming available, with latecomers confirming their efficacy over Iressa. Tarceva’s sales fell 13.8% YoY to KRW 3.1 billion last year. This is the fifth consecutive year the drug saw declining sales after posting KRW 8.2 billion in 2019. Compared to the KRW 17.3 billion it had earned in 2016, Tarceva’s sales have more than halved. Tarceva’s sales are also on a decline due to the emergence of more effective second and third-generation targeted therapies. Tarceva also suffered a setback in 2016 when its maintenance therapy indication was removed for patients with stage IIIA or higher NSCLC. Also, Tarceva was not proven effective in retrospective clinical studies. Therefore, its sales are expected to continue to decline when combined targeted therapies are approved for use in the first line.
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- Professor Yoo discovers specific protein expression in HCC
- by Lee, Tak-Sun Mar 19, 2024 05:45am
- Professor Changhoon Yoo, Department of Oncology, Asan Medical Center On the 15th, CMIC Korea, a contract research organization (CRO), announced that the results of the RENOBATE (IIT, Phase II) trial led by Professor Changhoon Yoo (Department of Oncology, Asan Medical Center) were recently published in the international academic journal, Nature Medicine (IF=82.9). This is the first time the results of a clinical study conducted by a Korean researcher have been published in Nature Medicine. In the RENOBATE 42 patients with hepatocellular carcinoma were administered the immunoconology drug regorafenib in combination with the targeted anticancer drug nivolumab. The study used circulation tumor DNA and single-cell RNA sequencing analysis to identify the characteristics of immune cells expressed in patients who did not respond to the combination therapy. The recent development of immuno-oncology drugs, also known as 3rd generation anticancer drugs, that offer better anticancer effects with less toxicity and side effects, has raised hopes for many cancer patients. However, 3 out of 10 patients with HCC were either not responding to or getting worse with the use of targeted anticancer drug+immune-oncology drug combination therapy. The RENOBATE study found that these patients had more than 2 times more expression of a specific protein called TMEM176A/B. This is very promising news for HCC patients who were unable to see much effect with the use of existing anticancer therapies and raises expectations for further developments. The study, which has raised the profile of Korea’s anti-cancer research, was initiated by Professor Changhoon Yoo in 2019 with his collaborators and was completed 3 and a half years later in late 2022. Even though the study was an investigator-initiated trial, which usually has a small amount of research funding, CMIC Korea, the first clinical contract research organization (CRO) in Korea, took charge of monitoring, data management, and clinical analysis to ensure and collect accurate and ethical clinical research data. According to Professor Yoo, this has helped improve the credibility of his research, which has been recognized by peer review and Nature Medicine. This has also been mentioned in the methodology part of the paper as well. Professor Yoo said, "We will continue on our efforts to support patients suffering from incurable diseases through reliable clinical research."
