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- 2025-12-22 13:31:21
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- Promotion of new drugs·biosimilars at KOS annual conference
- by Son, Hyung Min Dec 02, 2024 05:49am
- The Korean Ophthalmological Society (KOS) held an annual meeting for three days starting on November 30 at Coex. Korean and international pharmaceutical and biotech industries are fiercely competing for marketing in the market for macular degeneration. Global companies, including Novartis, Roche, and Bayer, and Korean pharmaceutical companies, including Kukje Pharm, Samil Pharm, and Chong Kun Dang, have participated in the annual meeting of the Korean Ophthalmological Society (KOS), held for three days starting on November 30 at Coex in Samsung-dong, Seoul, to showcase their treatments. The treatment for macular degeneration has been dominated by Novartis' Lucentis and Beovu and Bayer's Eylea. The competition intensified with the recent introduction of Roche's new drug, Vabysmo. Additionally, Korean pharmaceutical companies specializing in ophthalmology have begun co-distributing Eylea biosimilars, Kukje Pharm with Celltrion, and Samil Pharm with Samsung Bioepis, thereby increasing competition in the market. "Offers benefit of extended administration interval"…intense competition between Vabysmo·Eylea·Beovu According to the industry on December 2, companies with original macular degeneration pharmaceuticals, such as Novartis, Bayer, and Roche, participated at the international conference of the KOS. (From left) Photo of Bayer, Novartis, and Roche booths. Bayer focused on promoting the higher-dose version of 'Eylea.' Eylea works by binding to vascular endothelial growth factor (VEGF)-A and -B and growth factors, thereby inhibiting the binding to VEGFR and preventing activation. Eylea is ranked No.1 in sales in the Korean market for macular degeneration. Eylea generated sales of KRW 96.7 billion last year, according to market research firm IQVIA. However, Bayer must prepare for drug entries and the introduction of biosimilars following the patent expiration. Bayer and Regeneron Pharmaceuticals have recently launched higher-dose Eylea (8 mg). Bayer plans to extend the administration interval with the higher-dose formulation. The lower-dose Eylea (2 mg) requires an administration every 2 months, whereas higher-dose Eylea extends the administration interval to once every 5 months. Novartis concentrated on promoting 'Beovu,' a treatment for macular degeneration. The company has two macular degeneration drugs, Beovu and Lucentis. 'Lucentis' has a mechanism similar to Eylea that inhibits VEGF-A, but the administration time is shorter. Eylea is administered once every 2 months, whereas Lucentis must be administered monthly. Also, Eylea provided superior improvement effects than Lucentis in the treatment of diabetic macular degeneration with a significant loss of vision. Novartis is concentrating on Beovu, a follow-up treatment for macular degeneration. Beovu has the benefit of once every 2-month administration intervals like Eylea. Roche focuses on 'Vabysmo,' a macular degeneration treatment targeting a new mechanism. After the treatment was approved for reimbursement in October 2023, it was introduced into the market as a latecomer. Unlike conventional VEGF treatments such as Lucentis and Eylea, Vabysmo also inhibits the angiopoietin-2 (Ang-2) pathway, thus inhibiting new blood vessel formation. The analysis suggests that blocking two independent pathways can more effectively stabilize blood vessels and reduce inflammation, abnormal vessel growth, and fluid leakage than the VEGF-A pathway alone. Existing treatments for diabetic macular edema (DME) include drugs with VEGF-inhibitory mechanisms, such as Eylea, Lucentis, Beovu, and Vabysmo. The treatments that show benefits in maintaining administration are leading the market. The market leader Eylea has recently extended the administration interval from once every 2 months to once every 5 months. Vabysmo, emerged as a significant competitor, can be administered once every 4 months. Korean pharmaceutical companies promote their biosimilars for macular degeneration Major Korean pharmaceutical companies are targeting the market with biosimilars to Eylea and Lucentis. (Clockwise from upper left) Photo of Kukje Pharm, Samil Pharm, Sam Chun Dang Pharm, and Chong Kun Dang Booths. Kukje Pharm and Samil Pharm have participated in the event with a Diamond sponsorship. In April, Kukje Pharm signed an exclusive domestic sales agreement with Celltrion for Eylea biosimilar, ' Eydenzelt.' Eydenzelt was launched in the market in September. Kukje Pharm suggests that the drug priced lower than Eylea could offer a benefit. Samil Pharm promoted Samsung Bioepis' 'Afilivu,' a biosimilar to Eylea. Afilivu was approved in South Korea in February. It was launched in May and emerged in the market first among Eylea biosimilars. In addition to the Afilivu deal, Samil Pharm and Samsung Bioepis are co-selling 'Amelivu,' a biosimilar to Lucentis. Samsung Bioepis forges a path in the market after receiving approval for the pre-filled syringe formulation last month in addition to the existing vial formulation. In addition to Samil Pharm, Samsung Bioepis, Kukje Pharm, and Celltrion, Sam Chun Dang Pharm is set to enter the market with its latecomer biosimilar to Eylea. In December 2023, Sam Chun Dang Pharm applied for approval of vial·pre-filled syringe formulations of Eylea biosimilar 'SCD411.' At the event, Chong Kun Dang showcased its Lucentis biosimilar 'Lucen BS.' The sales of Lucen BS last year amounted to KRW 500 million, which was far from what was expected. Chong Kung Dang plans to overturn the situation by reducing the price. Starting this year, the company reduced the price of Lucen BS from KRW 300,000 to KRW 150,000. The original Lucentis is priced at KRW 580,000 per vial, and Samsung Bioepis' Amelivu is priced at KRW 350,000 per vial. Chong Kun Dang plans to expand the market with a price advantage compared to the original treatments.
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- Antibody drug 'Fasenra' lands in KOR with EGPA indication
- by Eo, Yun-Ho Dec 02, 2024 05:49am
- Product photo of Fasenra. Astra Zeneca's Fasenra, an antibody drug for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA), is expected to be introduced in South Korea. According to industry sources on November 29, Astra Zeneca Korea has recently submitted an application to the Ministry of Food and Drug Safety (MFDS) for an expanded indication of Fasenra (benralizumab). The indication is for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) with polyangiitis. Fasenra received the Orphan Drug Designation (ODD) for the EGPA indication in March. It received orphan drug designation from the U.S. Food and Drug Administration (FDA) in 2018. AstraZeneca recently showcased findings from the MANDARA Phase III trial at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. This study directly compared Fasenra to GSK's antibody drug, 'Nucala (mepolizumab).' The MANDARA study evaluated the efficacy and safety of Fasenra compared to Nucala in patients with relapsing or refractory EGPA for 52 weeks at 4-week intervals or three monthly Nucala injections. The study included 140 EGPA patients receiving corticosteroid therapy, regardless of immunosuppressant use. The average age of participants was 52 years, and 60% were female. Among the participants, 66% had relapsing disease, and 60% had refractory disease. Study results showed that at 36 and 48 weeks, the remission rates for EGPA were 59% in the Fasenra group and 56% in the Nucala group, showing a slightly increased trend than Fasenra. However, this difference was not statistically significant, and non-inferiority was demonstrated. The secondary endpoints, such as remission duration and time to first relapse, produced comparable outcomes in the Fasenra and Nucala groups. Similarly, average blood eosinophil counts at week 52 were reduced from 306/µL to 32.4/µL in the Fasenra group and from 384.9/µL to 71.8/µL in the Nucala group. Meanwhile, EGPA is a systemic vasculitis associated with asthma, eosinophilia, sinusitis, pulmonary infiltrates, and neuropathy. The disease can cause damage to multiple organs, including the lungs, skin, heart, gastrointestinal tract, and nervous system. This damage accumulates over time and can become fatal if left untreated. Fasenra is a monoclonal antibody that directly binds to the interleukin-5 (IL-5) receptor alpha on eosinophils, inducing rapid and near-complete depletion of blood and tissue eosinophils through programmed cell death in most patients. Currently, Fasenra is approved in multiple countries worldwide as an add-on maintenance therapy for severe eosinophilic asthma and has received approval for self-administration in the United States and Europe. In South Korea, Fasenra was approved by the MFDS in June 2019 for severe eosinophilic asthma. It has recently passed the Drug Reimbursement Evaluation Committee (DREC) review of the Health Insurance Review and Assessment Service (HIRA).
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- Industry speeds up the development of bispecific antibodies
- by Son, Hyung Min Dec 02, 2024 05:49am
- The Korean pharmaceutical industry is accelerating the clinical trials of bispecific antibodies to secure solid tumor indications. Bispecific antibodies, which have an additional specific antigen binding site compared to monoclonal antibodies, are recognized for their clinical benefits. GC Biopharma, Hanmi Pharmaceutical, ABL Bio, and Immuneoncia are among the companies developing bispecific antibodies for solid tumors. According to industry sources on the 30th, GC Biopharma recently signed a memorandum of understanding with Kanaph Therapeutics to develop a bispecific antibody-drug conjugate (ADC). GC Biopharma and Kanaph Therapeutics starts development of a bispecific antibody GC Biopharma and Kanaph Therapeutics starts development of a bispecific antibody The agreement, which includes an exclusive right for options, allows GC Biopharma to join the development upon meeting agreed milestones for the bispecific ADC candidate currently being developed by Kanaph Therapeutics. ADCs are being developed against targets expressed in a variety of solid tumors, which GC Biopharma believes will enable the treatment of a broader patient population. Kanaph Therapeutics is developing immuno-oncology drugs through the Antibody-Cytokine Fusion Protein Platform 'TMEkine™, and is evaluated to own a pipeline that can overcome the unmet needs of existing therapies through its ADC platform and synthetic drugs. In addition to GC Biopharma, the company has also successfully transferred its bispecific antibody technology to Dong-A ST in 2022. Bispecific antibodies are drugs that can bind to two different antigens simultaneously, or to two different epitopes on the same antigen. In particular, anticancer drugs need to cross the blood-brain barrier (BBB) to increase drug permeability. Bispecific antibodies have the advantage of crossing the BBB through targeted binding to receptors on the surface of the blood-brain barrier. The major bispecific antibodies approved for hematologic cancers are Roche's Lunsumio and Columbvi, AbbVie's Epkinly, and Pfizer's Elrexfio. In major solid tumors, bispecific antibody development has been challenging due to the low number of T-cells, which are needed to kill tumors and exhaust T-cell function. Recently, companies have been developing bispecific antibodies for solid tumor indications by combining antibodies that bind to antigens that regulate the activity of immune cells and antibodies that bind to specific antigens on tumor cells. Pharmaceutical companies are developing bispecific antibodies by considering various biomarkers such as PD-L1, which is targeted by immuno-oncology drugs, and NECTIN4 and TROP-2 of ADCs. 한미약품·에이비엘바이오·이뮨온시아 등 고형암 타깃 이중항체 개발 한미약품, 에이베일바이오, 이뮨온시아 등은 고형암을 타깃해 이중항체를 개발하고 있는 대표적인 회사다. 한미약품의 이중항체 후보물질 ‘BH3120’은 최근 임상1상에 진입했다. BH3120은 4-1BB와 PD-L1을 동시에 타깃한다. PD-L1은 키트루다, 옵디보 등 면역항암제들이 효과를 증명한 타깃으로 한미약품은 4-1BB 단백질 타깃을 더해 효과를 늘리겠다는 계획이다. 임상에서 BH3120은 종양미세환경과 정상조직 사이에서 면역활성의 디커플링 현상을 보여주며 안전성을 확인했다. 한미약품은 면역항암제 외에도 추가적인 항암제와의 병용 가능성도 열어두고 있다. 에이비엘바이오는 국내사 중 가장 많은 이중특이항체 후보물질을 보유하고 있다. 현재ABL001(VEGFxDLL4), ABL111(Claudin18.2x4-1BB), ABL503(PD-L1x4-1BB) 등 7개 이상 파이프라인을 보유하고 있다. #SB-Hanmi Pharmaceutical, ABl Bio, Immuneoncia, and others develop bispecific antibodies targeting solid tumors #EB Hanmi Pharmaceutical, ABL Bio, and Immuneoncia are some of the representative companies that develop bispecific antibodies that target solid tumors. Hanmi Pharmaceutical's bispecific antibody candidate BH3120 recently entered Phase I clinical trials. BH3120 simultaneously targets 4-1BB and PD-L1. PD-L1 is a target that immuno-oncology drugs such as Keytruda and Opdivo have proven effective against, and Hanmi Pharmaceutical plans to increase its effectiveness by targeting the 4-1BB protein. In clinical trials, BH3120 showed a decoupling of immune activity between the tumor microenvironment and normal tissue, confirming its safety. In addition to immuno-oncology drugs, Hanmi Pharmaceutical is open to the possibility of combining BH3120 with other anticancer drugs. ABL Bio has the largest number of bispecific antibody candidates among domestic companies. Currently, ABL Bio has more than 7 pipelines, including ABL001 (VEGFxDLL4), ABL111 (Claudin18.2x4-1BB), and ABL503 (PD-L1x4-1BB). ABL Bio is co-developing ABL001 with Handok. Handok has entered into a license agreement with ABL Bio for ABL001’s rights in Korea and has been leading a Phase II clinical trial of ABL001 in Korea since February 2021, focusing on biliary tract cancer. ImmuneOncia’s IMC-201 is a proprietary bispecific antibody utilizing CD47 and PD-L1. In preclinical studies, IMC-201 has been shown to bind strongly to CD47/PD-L1-expressing solid and hematologic cancer tumor cells while selectively acting on cancer cells. Tiumbio has confirmed the preclinical efficacy of its dual inhibitor TU2218. TU2218 simultaneously blocks the transforming growth factor (TGF-ß) and vascular endothelial growth factor (VEGF) pathways, which are known to interfere with immuno-oncology drug activity. This maximizes the efficacy of immuno-oncology drugs. TU2218 in combination with an anti-PD-1 agent improved tumor growth inhibition compared to conventional chemotherapy in a mouse model of breast cancer. In a colorectal cancer model, a 3-drug combination showed promise. TU2218+anti-PD-1 agent+anti-CTLA-4 agent inhibited tumor growth compared to placebo+anti-PD-1+anti-CTLA-4 agent. The TU2218 triple combination inhibited tumor growth by 84% compared to 70% in the control group. TU2218 also demonstrated 99% tumor growth inhibition in combination with an anti-PD-1 agent and Lenvatinib.
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- Is RWD needed for post-listing control of PE exempt drugs?
- by Eo, Yun-Ho Dec 02, 2024 05:49am
- The budget is tight, but the use of high-priced drugs continues to rise. The government is beginning to feel the strain of the systems it has put in place to increase access to new drugs, especially the pharmacoeconomic evaluation (PE) exemption system, which is increasingly being utilized and being subject to criticism. "The purpose of the post-listing control system is to secure additional evidence for medicines that have unclear safety and efficacy for patients. It will improve the quality of Korea’s healthcare by providing a medical reaffirmation process for such medicines." This was the government's stated intent. The government's good intentions aside, the industry has not received it well. This is due to the fear that the introduction of the system will eventually lead to "drug price cuts". Add to that the idea of using real-world evidence (RWE), or real-world data (RWD), to reevaluate drugs reimbursed through the PE exemption track, the concept has raised industry eyebrows. RWE lacks evidence base...encourages “Korea passing” The approval of a new drug is usually based on a randomized controlled trial (RCT). The PE evaluation and cost-effectiveness of the new drugs are also conducted based on this data. However, unlike RCTs, RWDs are not controlled data that are designed to accurately determine the efficacy of a drug. There are many variables that can introduce bias, such as what comorbidities the patient has, what prior medications they have taken, and whether the patient was adherent to the dose and frequency of the medication. The generally accepted levels of data evidence from high to low are meta-analyses, systematic reviews, RCTs, controlled clinical and observational studies, uncontrolled observational studies, case reports, and expert opinion; RWE is considered to be at the "uncontrolled observational study-case report" level. The Korean Research-based Pharmaceutical Industry Association (KRPIA) said, "RWE can be used to extract any desired results, depending on the intent of the collating entity. It is a risky idea to use data with a high risk of bias for the post-listing control of listed drugs. Since it is not generated in a controlled environment like an RCT, there are too many other factors to consider, including numerous crossovers, comorbidities, and use of concomitant medications." "RWEs can create contradictions and can overturn the results of RCTs that are higher level evidence. Rather, RWE should be used as a complementary tool to address uncertainties at the approval stage." Some argue that the introduction of such a post-listing control system could aggravate the "Korea passing" phenomenon in the pharmaceutical industry. If the government requires companies to submit data such as RWE post-listing, the companies will have to spend additional costs and time to generate such data, and if the data is then used as a basis for drug price cuts, it is inevitable that more pharmaceutical companies will be skeptical about launching new drugs in Korea. "Creating customized RWE data for each individual country is a huge burden for pharmaceutical companies," said a Market Access (MA) representative from a multinational pharmaceutical company. Even if a post-listing control system is introduced, the necessary data should be generated by a state-led registry, and the quality be assured." Must it be RWD? Can’t the drugs be managed with existing systems? Whether RWD is necessary is quite controversial. Korea's post-listing control system is already criticized by the industry for being tight. The Ministry of Health and Welfare proposed a plan to strengthen reimbursement management for high-priced drugs for serious diseases in 2023. In the plan, "high-priced drugs" were defined as ▲"one-shot drugs" that are expected to have long-term effects with a single treatment or drugs that require more than KRW 300 million/year of national health insurance finances per person, and were subject to reimbursement management measures. As a result, currently listed innovative drugs that have uncertainties (e.g., Kymriah, Zolgensma, Luxturna) are managed through the “performance-based reimbursement” type of the Risk-Sharing Agreement (RSA) scheme as well as the cost-effectiveness-based post-marketing evaluations, etc. The industry’s point is that systems already in place today are sufficient to manage the uncertainty that accompanies the effect of new drugs. "High-priced drugs have been reimbursed through various types of RSA, including performance-based and expenditure cap type RSA, so it is questionable whether additional follow-up measures are really necessary in addition to these arrangements, especially when the pharmaceutical companies already filter out patients that show uncertain efficacy and safety with their drugs and refund the expenses to the government under performance-based RSA," said KRPIA. "For ultra-high-priced drugs that cost over KRW 300 million per person a year and have a small number of target patients, they should be managed through a patient-level performance-based RSA or an individual contract-based drug performance evaluation system that generates individual data for each drug's situation," it added.
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- oHCM drug 'Camzyos' gets greenlight for reimb
- by Eo, Yun-Ho Nov 29, 2024 05:55am
- Product photo of BMS Korea’s Camzyos 'Camzyos,' a new drug to treat obstructive hypertrophic cardiomyopathy (oHCM), will finally be listed for reimbursement. The Ministry of Health and Welfare (MOHW) held the 23rd Health Insurance Policy Review Committee meeting on November 28, announcing that BMS Korea’s Camzyos (mavacamten), a new drug used to treat obstructive hypertrophic cardiomyopathy (oHCM) will be reimbursed. As a result, prescriptions for Camzyos are expected to increase starting in next year (December). Camzyos, which was approved in May 2023, received a re-assessment status during the Drug Reimbursement Evaluation Committee (DREC) review of the Health Insurance Review and Assessment Service (HIRA). After that, it passed the DREC review and entered a drug pricing negotiation in August, but no decision was reached regarding Camzyos during the negotiation period (60 days). Camzyos is the only drug that selectively inhibits cardiac myosin-actin cross-bridge formation, which is the cause of oHCM. Camzyos' mechanism involves dissociating myosin from actin, relaxing overstimulated heart muscle, and thereby improving left ventricular outflow tract (LVOT) structure and LVOT outflow obstruction. Due to the lack of available treatments for oHCM for a long time, off-label medications have been used to manage symptoms. After Camzyos launched, the European Society of Cardiology (ESC) updated its guidelines for managing cardiomyopathy for the first time in about nine years. Previously, the guidelines for HCM were based on evidence limited to small-scale monitoring data, retrospective analysis results, and consensus opinion. However, Camzyos has completely changed this situation. Two large-scale, phase 3 clinical trials conducted as randomized controlled trial (RCT) have confirmed the significant effect of Camzyos. Consequently, ESC guidelines recommend Camzyos with the highest evidence level A for the first time in treatment options. American College of Cardiology (ACC) and the American Heart Association (AHA) are preparing to update their guidelines. Furthermore, based on this phase 3 trial evidence, the U.S. FDA granted Camzyos Breakthrough Therapy Designation (BTD) and approval. Meanwhile, the efficacy of Camzyos was demonstrated through Phase 3 EXPLORER-HCM trials. In this trial, Camzyos improved primary endpoints, which were the patient’s symptoms (NYHA classification) and exercise capacity measured with peak oxygen uptake (pVO2), more than twofold compared to the placebo. 20% of the patients treated with Caymzyos met the NYHA classification and pVO2 improvements. It also reduced the LVOT outflow obstruction index by four-fold after exercise. 7 out of 10 patients who received Camzyos treatment had improved indexes and ended up not considering surgery, and they maintained the effects for 30 weeks.
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- Deregulate to foster new modalities like ADC, gene therapy
- by Son, Hyung Min Nov 29, 2024 05:55am
- Seung-Kyou Lee, Vice President of KoreaBio New modalities (therapeutic approaches) such as antibody-drug conjugates (ADCs), obesity drugs, and gene-editing technologies need dramatic regulatory relief to settle in Korea, said experts. On the 14th, KoreaBio held a seminar on trends and prospects of the bio-industry at the El Tower in Seocho-gu, Seoul. At the event, Seung-Kyou Lee, Vice President of KoreaBio, presented his assessment of the bio-industry this year and its prospects. Lee cited gene therapy drugs, obesity and diabetes drugs, and ADCs as new modalities that the Korean pharma-bio industry is interested in and developing. With the recent commercialization of gene therapy drugs such as Exa-cel, and Lyfgenia overseas, domestic companies with genetic scissors technology have also started busily developing new drugs. Genetic scissors are molecular biological tools that recognize and cut specific areas in the DNA to edit genes. Currently, domestic biotech companies such as ToolGen, Organoid Sciences, and GeneKOre have entered the market and started developing products. Lee said that the LMO Act should be revised to vitalize the domestic gene therapy market. Recently, the LMO Act was proposed to distinguish between genetically engineered organisms (GEOs) and genetically modified organisms (GMOs) to exempt them from regulations. The LMO Act aims to separate GEOs from GMOs and exempt them from the regulations that apply GMOs, ultimately to foster Korea’s GEO industry. "Gene therapy is rapidly emerging as a global industry trend. If Korea’s regulations are not eased, it will be difficult for domestic companies to grow," he said, adding, "GMO exemptions or ease of regulations for gene-edited crops/seeds is necessary." Diabetes, obesity drugs, ADCs also on the rise..."Need more government R&D support for biotechs" Treatments for obesity and diabetes have also emerged as a major R&D trend in the Korean biotech industry. The use of glucagon-like peptide (GLP-1) injectables has grown dramatically due to their ability to achieve effective weight loss. As GLP-1-based obesity drugs such as Saxenda, Wegovy, and Zepbound have shown dramatic weight loss effects in clinical trials, newcomers are mostly targeting GPL-1. Currently, various domestic pharmaceutical biotech companies such as Hanmi Pharmaceutical, Peptron, Inventage Lab, Dong-A ST, and Progen have entered the market. Lee explained, "The number of companies developing drugs for diabetes and obesity will continue to grow. However, investment sentiment in biotech companies is weak. This is why it is time to expand government R&D support for biotech companies." He pointed to "ADC" as one of the modalities that will emerge as an R&D trend this year and beyond. ADCs are anticancer drugs made by linking antibodies that bind to specific target antigens on the surface of cancer cells with drugs that have cell-killing properties. ADCs have the advantage of using the selectivity of the antibody to its target, and the killing activity of the drug that selectively acts on cancer cells, thus increasing the therapeutic effect while minimizing side effects. LigaChem Biosciences, Pinotbio, and Orum Therapeutics have succeeded in exporting ADC technology to multinational pharmaceutical companies and are being recognized for their technology. "It's time for a different level of effort to be invested compared to what we've been doing so far," said Lee, adding that securing funding is essential for biotechs to focus more on drug development. "I hope a small fund of KRW 30 billion to 50 billion can be created to be invested in the biotech sector." "We need to improve the conditions for maintaining the special listing in bio technology, such as relaxing the legal loss requirement and the threshold of KRW 3 billion in sales, and we would like to see support and incentives established for the self-reliance of Materials, Components, and Equipment businesses and stabilization of the supply chain of raw materials and pharmaceuticals."
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- Samsung Bioepis names Kyung-Ah Kim as new CEO
- by Nov 29, 2024 05:55am
- Kyung-Ah Kim, President and CEO of Samsung Bioepis Samsung Bioepis has changed its CEO for the first time since its launch. Kyung-ah Kim (56), Executive Vice President and Development Division Leader, has been appointed as CEO. This is the first female CEO appointed in the Samsung Group. Hansung Ko, who has served as CEO for 12 years since the launch of Samsung Bioepis, will take over as head of Samsung Future Business Division. Samsung Bioepis today announced the promotion of Kyung-Ah Kim to the position of President and CEO. Born in 1968, Kim completed her bachelor's and master's degrees in pharmacy at Seoul National University. She then earned a doctorate in toxicology from Johns Hopkins University in the United States. Kim is from the Samsung Advanced Institute of Technology (SAIT), which marks the start of Samsung Group's bio business. She joined SAIT in 2010 as a principal scientist in bio-drug development. Then she joined Samsung Bioepis in 2015 and has played a key role in all aspects of the business, including biosimilar development, process, quality, and licensing. The company said, “As the first female professional CEO of Samsung Group, Kim will not only provide a vision for growth and an opportunity for female talents to take on bold challenges, but will also serve as a role model for women, who make up more than half of Samsung Bioscience's workforce, and is expected to bring new energy into the organization.” Hansung Ko, who was appointed CEO of Samsung Bioepis upon its foundation in 2012 and led the company for 12 years, will head Samsung Electronics' Future Business Division. The Future Business Division was established in November last year, and Mr. Koh will lead the discovery of new businesses for Samsung Group.
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- 'Global obesity drug market 79 times bigger than Korea'
- by Son, Hyung Min Nov 29, 2024 05:55am
- Kang-Bok Lee, Marketing & Sales Excellence Lead at IQVIA Multinational pharmaceutical companies have been achieving significant growth through a strategy that focuses on core industries and key therapeutic areas (TA)s. On the 14th, KoreaBIO held a seminar on trends and prospects of the bio-industry at Yangjae El Tower. On this day, Kang-Bok Lee, Marketing & Sales Excellence Lead at IQVIA, shared the trends of the global pharmaceutical industry. According to Lee’s data, the global pharmaceutical market was worth USD 1.44 trillion (about KRW 191.6 trillion) last year. This is 79.1 times the size compared to Korea's market, which is USD 18.2 billion (about KRW 25.5 trillion), The growth of the global pharmaceutical market was driven by diabetes, obesity, anticancer, and autoimmune disease drugs. In particular, GLP-1 class diabetes and obesity drugs showed remarkable growth. Eli Lilly's GLP-1 diabetes drug Mounjaro generated KRW 6.48 trillion in sales last year, up 971.2% from 2022. Launched in May 2022, Mounjaro grew rapidly last year after generating KRW 640 billion in sales the same year. Novo Nordisk's GLP-1 class of diabetes drugs also had a strong year. Ozempic generated sales of KRW 5.48 trillion last year, up 52% from the previous year. Sales of Rybelsus, an oral treatment with the same ingredient generated KRW 1.44 trillion, up 140% from 2022. The obesity drug Saxenda generated KRW 1.225 trillion in sales last year, up 9.8% year-on-year. Wegovy surpassed KRW 300 billion in sales last year despite facing supply challenges. "The growth of global innovation brands is being driven by a small number of countries, products, and companies. Premium, innovative new drugs such as Keytruda and obesity treatments have driven growth in the global pharmaceutical industry." Global pharmaceutical companies steadily launch new drugs..."Expect to focus on core industries and TA" He expects an average of 70 new drugs to be launched between next year and 2028, with anticancer and obesity drugs driving growth. "Immuno-oncology drugs like Keytruda have a wide range of indications. The development of one drug has the effect of developing multiple therapies. Therefore, multinational pharmaceutical companies are showing a trend of new drug development that focuses on core industries and core therapeutic areas." "Oncology and obesity are expected to be the fastest growing segments. Oncology is expected to grow at a CAGR of 15% and obesity at a CAGR of 26% through 2028." In particular, Lee noted that companies that focus on one area, such as Mounjaro, Wegovy, SKYRizi, and Keytruda, are seeing strong growth, driving label expansions and ingredient re-engineering. "Novo Nordisk, Lilly, AbbVie, and MSD are companies that have seen success by focusing on a single therapeutic area. We believe that their products will continue to lead the global pharmaceutical market in the future,” said Lee. "Just as GLP-1 obesity drugs were developed as diabetes treatments and then became highly successful as obesity treatments, we expect re-engineering and labeling to emerge as a global R&D trend in the future."
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- Sales rights for Viviant·Tuvero·Akarb to be transferred
- by Kim JiEun Nov 28, 2024 05:55am
- Due to changes in sales rights for blockbuster items that are frequently dispensed, the pharmaceutical supply and demand are expected to be affected in the end-of-year period and early 2025. According to the pharmaceutical distributor industry on November 26, several pharmaceutical companies are expected to change their distributors at the end of this year or early next year. Medication with confirmed changes to sales rights is Pfizer's Viviant Tab. Pfizer Korea has recently sent an official letter to wholesale distributors, hospitals, and pharmacies notifying 'The changes to the supply chain for Viviant.' Pfizer stated in the official letter that Pfizer will be responsible for distributing Viviant Tab 200 mg, previously distributed by Handok, starting December 1. The company requested that any inquires about returns for remaining stock from previously distributed items to be maded to Handok, and any inquiries after December 1 be directed to Pfizer. Pfizer also announced that the distribution of Caverject Injection 10 ug and 20 mg, previously distributed through Novamedix will be changed to direct distribution effective December 1. Pfizer stated any inquiries about remaining distributing stock for this item could be made to Novamedix, and inquiries related to distribution after December 1 should be directed to Pfizer. In addition to these items, more products with expected changes to sales rights in early next year. Sales rights for most of Boryoung's items will be changed, and the company seems to be informing its pharmaceutical distributors. The wholesale distributor said that Daewon Pharmaceutical has been responsible for distributing Boryoung's Tuvero Tab and Akarb Tab, but Boryung will directly distribute them starting next year. Yungjin Pharmaceutical has been distributing Boryung Buspar Tab since 2018. Boryung is highly like to distribute the drug directly next year. As changes to distributors have been announced, it is expected to affect the end-of-year pharmaceutical supply and demand. "Special circumstances such as changes to the distributor are likely to affect the supply and demand. The effective date may be postponed beyond what the pharmaceutical companies have previously announced," a pharmaceutical wholesale employee said. "We must prepare for possibilities such as difficulty in returning remaining stocks and unstable supply and demand for such items in early next year."
- Company
- Lilly appoints Stacie Liu to head the CardioMetabolic Health
- by Eo, Yun-Ho Nov 28, 2024 05:54am
- Stacie Liu, Senior Director, CardioMetabolic Health Business Unit, Lilly Korea Lilly Korea has named Stacie Liu (37), as the new Senior Director of its CardioMetabolic Health Business Unit On the 1st, Lilly Korea announced that it had appointed Stacie Liu as the Senior Director of its CardioMetabolic Health Business Unit. In this role, Liu will be responsible for setting and executing the business strategy for Lilly's diabetes and obesity portfolio in Korea, including the company's type 2 diabetes and obesity treatment, Mounjaro. Lilly's decision is notable in that Liu is a young, foreign, female leader. This is in line with Lilly's culture, which believes in the power of diversity, equity, and inclusion. As of 2023, one in two (49%) of Lilly’s executives were women. This represents a 4%p increase over 4 years from 2019. Five of the 12 Board of Directors are also women, with their ages ranging from early 50s to late 60s. “At Lilly, our goal is to help people live better everyday lives through dedicated and exploratory development of new medicines, and we need the best and brightest minds with the most creative ideas to address the world's most pressing health challenges,” said Liu. “Lilly's success today is founded on the corporate culture that embraces diversity and values equity. Based on this culture, Lilly Korea will be committed to delivering life-changing medicines promptly to patients in Korea.” Liu has previously held positions at Lilly's Shanghai office and U.S. headquarters and has a bachelor's degree in International Relations and Affairs from Fudan University in Shanghai, China. Fudan University is a world-renowned university, ranked 31st in the world and 3rd in China as of 2022.
