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- 2025-12-23 06:56:10
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- AI-based liquid biopsy companies deliver tangible results
- by Son, Hyung-Min Mar 28, 2024 05:52am
- Domestic companies have started to deliver tangible results with their liquid biopsy technology. The early cancer diagnosis accuracy of GC Genome’s ai-CANCERCH and IMBdx’s CancerFind were found to be over 80%. EDGC's (Eone-Diagnomics Genome Center) test showed an 80% sensitivity in diagnosing colorectal cancer. Liquid biopsy detects diseases from blood, body fluids, or urine, enabling faster and more convenient testing than standard biopsy, which involves removing the tumor directly. Liquid biopsy can be conducted even without the patient’s tissue. Extracting tissue from cancer patients becomes increasingly difficult after the development of chemoresistance. When a biopsy is first performed, tissue extraction is usually possible in more than 90% of cases, but that probability gradually decreases for patients who develop resistance to anticancer drugs. For this reason, liquid biopsy has been considered as a replacement for regular biopsy, but is only applicable to certain cancers and is not 100% accurate, thereby requiring further testing. However, it can be useful for early diagnosis and prediction of cancer, and major liquid biopsy diagnostic companies have been targeting the early cancer diagnosis market. Korean company secures a platform that can diagnose early solid cancer through blood According to data recently released by GC Genome on the 28th, ai-CANCERCH’s accuracy in diagnosing Stage I cancer reached 81.1%. ai-CANCERCH is an AI-based liquid biopsy diagnostic platform developed by GC Genome. The program was released in Korea in September last year. ai-CANCERCH’s uses AI algorithms to extract circulating tumor DNA (ctDNA) from cell-free DNA (cfDNA) floating in blood vessels and use next-generation sequencing (NGS) to identify the presence of tumors at an early stage. Cancer cell-derived cfDNA is DNA released from the cell into the blood and owns the characteristic of autologous cells. Ai-CANCERCH’s testing accuracy was verified through analysis of a total of 5,000 samples, involving more than 1,300 cancer patients and more than 3,700 general people. Ai-CANCERCH can diagnose the presence six cancers - lung, liver, colorectal, pancreatic, esophageal, and ovarian cancers. Earlier this month, GC Genome signed contracts for diagnostic genome analysis services with 6 companies – 1 in Jordan, 3 in Saudi Arabia, 1 in Oman, and 1 in Pakistan. In addition to GC Genome, IMBdx and EDGC are also developing AI-based liquid biopsy tests. IMBdx develops precision cancer diagnostics technology and was founded by Dr. Tae-You Kim, Professor of Medical Oncology at Seoul National University Hospital. The company is set to go public on KOSDAQ next month. IMBdx’s early cancer diagnosis platform is called CancerFind. It can diagnose 8 types of cancers including colorectal, liver, lung, prostate, ovarian, stomach, and pancreatic cancers, through a single blood draw. CancerFind analyzes the genetic and epigenetic signatures of ctDNA to detect cancer and provide information about the cancer site. It is a quick and easy cancer screening tool that can be used not only by those in need of biopsy, but also by general patients who have difficulty receiving imaging and endoscopy tests. To date, the company's cancer diagnostic test showed a 86% sensitivity and can localize cancer with 83% accuracy. EDGC has been demonstrating its liquid biopsy technology in early cancer screening for colorectal and lung cancer. EDGC uses its liquid biopsy-based platform OncoCatch to extract ctDNA from cell-free cfDNA floating in the blood. It then applies an AI algorithm to measure epigenetic changes associated with cancer development, enabling cancer diagnosis at the earliest stage. EDGC evaluated its cancer prediction model by type on 191 cancer patients and 126 members of the general public and found that the sensitivity was 78.1% for colorectal cancer and 66.3% for lung cancer. EDGC plans to first target the North American market with its testing tool. In August last year, the company joined the U.S. Cancer Moonshot project aimed at conquering cancer. Cancer Moonshot is a cancer conquest project promoted by the Biden administration that aims to reduce the mortality rate of cancer patients by over 50% within the next 25 years by accelerating the development of cancer R&D. EDGC also started exporting its liquid biopsy technology after acquiring the US company GDxLab last year.
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- Dt&CRO signs MOU with U.S. company Radyus Research
- by Nho, Byung Chul Mar 27, 2024 06:04am
- On the 25th, Dt&CRO announced that it had signed a memorandum of understanding (MOU) with Radyus Research, a U.S. clinical consulting organization. The MOU is expected to add momentum to the company’s full-cycle consulting service that is provided to domestic pharma and biotech companies that apply for Investigational New Drug (IND) or file a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA). As a GLP-certified organization, Dt&CRO is a full-service CRO capable of conducting non-clinical trials, Phase I-III clinical trials, post-marketing surveillance (PMS), observational studies (OS), as well as pharmacovigilance (PV) studies in various fields including pharmaceuticals, medical devices, and health function foods. Its another advantage is that the company works closely with its central laboratory HuScience, and SafeSoft, which develops and provides e-clinical solutions. Radyus Research is a consulting service provider for INDs. The company has experts with experience in various fields including pharmaceutical, biotech, academia, hospitals, and CROs. Building on its experience of receiving more than 100 IND approvals and 20 NDA approvals since its inception, the company has partners around the world, including those in the U.S., Europe, and Asia, and has signed an agreement with Dt&CRO to make the first step into Korea’s industry. Under the agreement, the two companies will provide a 3-step customized service for efficient application and approval of non-clinical and clinical trials by the FDA and EMA. To this end, the 2 companies will combine Dt&CRO’s Good Laboratory Practice (GLP) and Radyus Research’s US and European certification consulting expertise. In particular, Dt&CRO will be responsible for conducting testing and establishing consulting plans in accordance with the GLP standards. The two companies will meet at CPHI North America in May to discuss ongoing business, and then hold a joint seminar in Korea in July. Chae-Kyu Park, CEO of Dt&CRO, said, "In order for domestic companies to obtain IND/NDA approval from the FDA/EMA, they had to inconveniently receive consulting for non-clinical trials and IND/NDA approvals separately at different companies. For this reason, the companies had to endure a lot of time and money in each stage of company selection, testing, and consulting. Through the MOU, we can now provide quick and accurate services to help companies enter the overseas pharmaceutical market at a reasonable cost.”
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- No news on Phesgo's reimb progress for 7 months
- by Eo, Yun-Ho Mar 27, 2024 06:04am
- The insurance reimbursement process for Phesgo, a drug that was expected to benefit from the preferential drug pricing system, is making little progress. No news has been heard on its progress for 7 months. Roche Korea’s Perjeta (pertuzumab+ trastuzumab), a subcutaneous injectable combination of the company’s Perjeta and Herceptin, passed the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee review in August last year. Since then, Roche has been negotiating with the National Health Insurance Service on Perjeta’s supply and quality control terms after the application was reported to the Drug Reimbursement Evaluation Committee. However, there has been no news of a settlement or breakdown of the negotiations to date. Phesgo was recognized as the first biobetter anticancer drug for its innovativeness in improving patient convenience and reducing treatment time by converting the intravenous Herceptin and Perjeta injections into a fixed-dose subcutaneous injection. If a patient with metastatic HER2-positive breast cancer who was receiving maintenance therapy every 3 weeks with intravenous Herceptin-Perjeta switches to Phesgo SC, his or her total dosing and monitoring time is reduced by 90% from 270 minutes (90 +180 minutes) to 20 minutes (5 +15 minutes). In addition, Phesgo is administered subcutaneously to the thigh, rather than through a vein, reducing the risk of blood vessel and nerve damage from repeated intravenous injections. These benefits of Phesgo can serve as an advantage amid the current healthcare disruptions present in Korea. However, due to delays in the approval process, which could have been completed as early as the end of last year, have rendered the drug a “pie in the sky” for the patients. In the case of Nexviazyme (avalglucosidase alfa), which was the first biobetter drug to receive preferential treatment, the process took five months to complete. Therefore, it remains to be seen how much longer the tug-of-war between the government and Roche, which began last year, will last. The NCCN guidelines state that Phesgo can replace Perjeta-Herceptin, and in the UK, 90% of patients treated with Herceptin and Perjeta switched to Phesgo in the first year of Phesgo's launch. Therefore, a significant number of patients treated with Herceptin-Perjeta are likely to switch to Phesgo upon its approval in Korea. Meanwhile, in 2016, the government announced a plan to provide preferential drug pricing for biobetters that show an improvement over approved biosimilars and biologics that have contributed to the improvement of healthcare in Korea. Given the difficulty of developing biobetters compared to synthetic drugs, the price of biobetters was set at 100% to 120% of the price of the target product (original, etc.), and Nexviazyme became the first drug to benefit from the measure.
- Company
- Adtralza reimb drives biologics competition in atopy market
- by Eo, Yun-Ho Mar 26, 2024 06:30am
- (Photos from the left) Sanofi’s Dupixent and LEO Pharma’s Adtralza. Biopharmaceuticals face competition in the atopic dermatitis sector. According to industry sources, LEO Pharma’s Adtralza (tralokinumab), a treatment for atopic dermatitis with an underlying mechanism of neutralizing interleukin-13 (IL-13), is anticipated to launch with reimbursement starting in May. Adtralza is the second biologic approved for atopic dermatitis, following Sanofi-aventis Korea’s 'Dupixent (dupilumab).' Adtralza was approved in Korea last August and passed the review by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA). The company recently completed price negotiations with the National Health Insurance Service (NHIS). It can expect to be listed as early as April, but the company is preparing for an official launch in May. Adtralza is indicated for adults (18 years of age and over) and children (12-17 years of age) with moderate to severe atopic dermatitis that is not adequately managed by topical treatments or for whom topical treatments are not advised. Adtralza’s recommended initial dose is 600 mg (given as four injections of 150 mg) followed by 300 mg (given as two injections of 150 mg) every two weeks. Adtralza provides a convenient dosing option for patients with moderate to severe atopic dermatitis. At the doctor’s discretion, patients who achieve clear or almost clear skin after 16 weeks of treatment may consider dosing every fourth week. This drug is a biopharmaceutical that specifically targets IL-13. While Sanofi-aventis Korea’s Dupixent (dupilumab) targets both IL-4 and IL-13, it is difficult to compare the mechanism of actions of the two drugs directly. To what extent Adtralza's entry will impact the atopic dermatitis market competition remains to be watched. Dupixent is steadily expanding its presence in the Korean market. It renewed the Risk Sharing Agreement (RSA) contract in February of last year. Dupixent secured an initial four-year RSA contract from January 2020 to December 2023. The type of contract was a refund model, a total expenditure cap model, and an initial treatment cost refund model. Initially, Dupixent was covered by reimbursement for treating atopic dermatitis in adults but later expanded to include children and adolescents aged six years and above. Recently, it is being discussed for the reimbursement expansion for treating toddlers aged six months to five years with severe atopic dermatitis. Additionally, it is considered for the reimbursement expansion for treating adult asthma, in addition to atopic dermatitis. The market for atopic dermatitis comes alive as orally administered JAK inhibitors join. JAK inhibitors that have indications of atopic dermatitis are Lilly Korea’s 'Olumiant (baricitinib),' Korea abbvie’s 'Rinvoq (upadacitinib),' and Pfizer Korea’s ‘Cibinqo (abrocitinib).’ These drugs are covered by insurance reimbursement.
- Company
- Sam Chun Dang Pharm introduces Eylea biosimilar to Europe
- by Nho, Byung Chul Mar 26, 2024 06:30am
- Sam Chun Dang Pharm. Sam Chun Dang Pharm announced on the 25th an exclusive distribution agreement for the Eylea biosimilar with nine Western European countries (UK, Belgium, Netherlands, Norway, Portugal, Sweden, Greece, Ireland, and Finland). Under the agreement, Sam Chun Dang Pharm will receive 55% of the partnering company’s net sales, further strengthening its presence in the European market. Sam Chun Dang Pharm has established a sales network in the UK, Germany, Spain, and Italy, and the current agreement has established a stepping stone for entering the UK market, which is the biggest market in Europe: “Sam Chun Dang Pharm was able to sign the agreement on the most favorable terms as we received 55% of the sales. This was possible because Eylea PFS (Pre-filled Syringe) dominates 90% of the total sales in the European market. Additionally, Sam Chun Dang Pharm took advantage of being the first-mover in the market by applying for EMA for the first time as a Eylea biosimilar PFS in Europe,” an official from Sam Chun Dang Pharm stated. And explained, “The product has price competitiveness, and it does not pose a potential infringement of original patent.” The fact that Sam Chun Dang Pharm is the only biosimilar developer to have signed contracts with advanced countries such as Europe, Canada, and Japan, besides companies with direct sales systems, proves its presence in the industry. In November last year, Sam Chun Dang Pharm achieved contract fees and milestones amounting to 50 million euros (approximately KRW 70 billion), including contracts with five European countries. They achieved the targeted contract fees and milestones in 14 countries, excluding France. According to the company's explanation, the amount is expected to increase as more country contracts are added. The French government passed a bill to promote the use of biosimilars, which is postulating the expansion of the French market. Sam Chun Dang Pharm is currently developing a new marketing strategy and will soon enter the French market with conditions tailored to this specific environment. The company is also in the final stages of contract negotiations with Eastern European countries. Including this recent contract, Sam Chun Dang Pharm has secured KRW 140 billion in contract payments and milestones, with expected sales exceeding KRW 6 trillion. The company plans to establish a dominant presence in major advanced countries' markets and plans to further expand its influence in the global healthcare sector. “In addition to closely monitoring opportunities to enter France, the last remaining country in Europe, and Eastern Europe, we are closely monitoring the trends in patent disputes with local partners in the United States, the most critical market in North America. We are currently negotiating and are establishing early sales strategies through patent strategies that reflect these trends,” a company official explained. “After finalizing this contract, “In addition to closely monitoring opportunities to enter France, the last remaining country in Europe, and Eastern Europe, we are closely monitoring the trends in patent disputes with local partners in the United States, the most critical market in North America. We are currently negotiating and are establishing early sales strategies through patent strategies that reflect these trends,” a company official explained. “After finalizing this contract, Sam Chun Dang Pharm will secure its presence in the European and North American markets, representing 80% of the global market. This achievement will be a significant stepping stone for Sam Chun Dang Pharm to become a leader in the global biosimilar market.” will secure its presence in the European and North American markets, representing 80% of the global market. This achievement will be a significant stepping stone for Sam Chun Dang Pharm to become a leader in the global biosimilar market.”
- Company
- Takeda’s colorectal cancer drug 'Fruzaqla' nears KOR entry
- by Eo, Yun-Ho Mar 26, 2024 06:30am
- New colorectal cancer drug New colorectal cancer drug 'Fruzaqla' is likely to receive approval for commercialization in South Korea. According to industry sources on the 11th, Takeda Pharmaceuticals Korea’s Fruzaqla (fruquintinib), designated as Global Innovative products on Fast Track (GIFT) by the Ministry of Food and Drug Safety (MFDS), is under review for approval. GIFT-designated pharmaceuticals are provided various supports for rapid commercialization, including ▲supports for preparing requirements for regulatory approval ▲rolling review process is applied, which enables regulatory review on prepared documents first ▲close communication between the regulatory reviewer and the developing company, such as briefing of an item and complementary support sessions ▲regulatory supports, including RA consulting. As a GIFT-designated product, Fruzaqla is expected to receive faster product approval. Fruzaqla received the Orphan Drug Designation last month in South Korea. The FDA designated Fruzaqla for priority review in May last year and approved the drug in November of the same year. Fruzaqla is indicated for ‘the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with flouropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, or who have been previously treated or cannot be treated with an anti-VEGF treatment, an anti-EFGR treatment (if RAS wild-type), and at least one of trifluridine plus tipiracil or regorafenib treatment.’ Fruzaqla is a VEGFR-1, -2, -3 receptors inhibitor that Takeda Pharmaceutical acquired the rights to the drug from Hong Kong Hutchmed. The efficacy of Fruzaqla was evaluated based on the FRESCO clinical trial conducted in China and published in JAMA and the global FRESCO-2 clinical trial published in LANSET. These clinical trials compared the combination therapy of Fruzaqla plus best supportive care (BSC) with placebo combination therapy in patients with previously treated metastatic CRC (mCRC). The FRESCO and FRESCO-2 clinical trials achieved primary endpoints and crucial secondary endpoints, demonstrating consistent effectiveness in 734 patients who received Fruzaqla treatment. In FRESCRO-2 clinical trial, the fruquintinib-treatment group yielded a median overall survival (OS) of 7.4 months, versus 4.8 months for the placebo group. In FRESCO clinical trial, the fruquintinib-treatment group yielded a median OS of 9.3 months, versus 6.6 months in the placebo group. The GIFT program designates products that fall into one of the following standards: ▲a medicinal product intended for the treatment of serious diseases, such as life-threatening cancers ▲a medicinal product intended for the prevention or treatment of infectious diseases with a serious threat to public health, such as an infectious disease outbreak caused by bioterrorism or pandemic ▲a new medicinal product developed by an innovative pharmaceutical company designated and notified by the Ministry of Health and Welfare ▲a combination of a medical device and a medicinal product designated for expedited review.
- Company
- 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).
- Company
- 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.
