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- 2025-12-22 05:56:45
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- Asthma drug 'Monterizine' sales rise despite generic entries
- by Kim, Jin-Gu Nov 12, 2024 05:51am
- Hanmi's asthma treatment, 'Monterizine,' successfully expanded its prescription sales over 10% Year-over-Year (YoY), despite the release of generics. Generic drugs had been listed for reimbursement in October 2023. The analysis suggests that Monterizine's continued sales expansion is because generic prices have not been reduced and, it maintains a strong market presence with its broader scope of use. Prescription sales 14%↑despite generic releases… Monterizine Chewable Tab is the only available treatment for young children According to the pharmaceutical market research firm UBIST on November 8, Hanmi's Monterizine recorded prescription sales of KRW 4.3 billion in Q3, which is an increase of 14% over a year compared to KRW 3.7 billion in Q3 2023. Monterizine is a combination drug containing the asthma treatment, 'Montelukast,' and the third-generation antihistamine, 'Levocetrizine.' Hanmi received approval for 'Monterizine Cap' in May 2017. The following April, Hanmi changed the formulation and received approval for 'Monterizine Chewable Tab' designed to be taken by chewing. After the launch of Monterizine Chewable Tab, prescription sales quickly expanded for the Monterizine series. The combined prescription sales of Monterizine Cap and Monterizine Chewable Tab have increased by 8%, from KRW 7.9 billion in 2019 to KRW 8.6 billion in 2020. It recorded KRW 9.7 billion in 2021, surpassing KRW 10 billion when the sales amounted to KRW 12.4 billion in 2022. Last year, it recorded KRW 15.6 billion, a 21% increase from the previous year. This year, Monterizine is maintaining solid sales. In Q4 2023, it surpassed KRW 4 billion for the first time, generating KRW 4.3 billion to KRW 4.4 billion in sales each quarter. Quaterly prescription sales of the original drug Monterizine (blue) and generics (ligt blue) (unit: KRW 100 million, source: UBSIT). Interestingly, generics of Monterizine were launched in October 2023. Typically, sales of original drug slow down after the generic launches, but Monterizine is following a different trend. The analysis suggests that Monterizine Chewable Tab is showing a strong market presence with its broader scope of use. The scope of use for the original Monterizine Cap and generics to Monterizine are limited to 'adults and adolescents at the age of 15 or older.' Monterizine Chewable Tab is prescribed to 'young children at the age of 6-14.' The analysis is that Monterizine Chewable Tab is widely used in the prescription market, especially because young children require frequent prescriptions in the case of asthma drugs. Drug price has been maintained despite generic releases…the generics formulation is different from the original Additionally, one of the reasons for continued sales of Monterizine is that it remains the same price following the generics' releases. Product photo of HanmiIn September 2021, generics companies challenged four patent cases of Monterizine. In September of the following year, they successfully avoided patents one after another. After losing the first trial, Hanmi appealed to the patent court, but the company soon withdrew. Since October 2023, Monterizine generics have launched. Six products that met the requirement for the highest price by conducting bioequivalence tests became listed at KRW 886 per tablet. 14 products that did not meet the bioequivalence test because they were produced by contract manufacturing organization (CMO) became listed at KRW 753 per tablet. The drug price of Monterizine was not reduced following the generic release. The original drug price is automatically reduced by 30% when generics are released. Monterizine drug price should have been reduced from KRW 886 to KRW 620, but it was not. This is because the generics have been developed in a formulation different from the original. The Health Insurance Review and Assessment Service (HIRA) reduces the original drug price by 30% in the first year when a product with the same formulation is launched. In the following year, the HIRA further reduces the drug price of the original by 53.55%. In this case, the 'same formulation' means the active ingredient, administration route, dosage, administration method, formulation, and efficacy·effects are matched. The original Monterizine is available in capsules and chewable tablets. Generic products received approval as tablets. The government analyzed that the generics are not in the same formulation as the original Monterizine. Therefore, the drug price of the original was maintained at KRW 886.
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- 'Vabysmo' for macular deg associated RVO indication expected
- by Eo, Yun-Ho Nov 12, 2024 05:51am
- Product photo of Vabysmo.The first bispecific antibody for eye diseases, 'Vabysmo,' is soon to be approved in South Korea for its indication of treating macular degeneration associated retinal vein occlusion (RVO). According to industry sources, Roche Korea's Vabysmo (faricimab) is being reviewed by the Ministry of Food and Drug Safety (MFDS) for its indication expansion. It is expected to be approved within the year. For RVO indication, it received the U.S. FDA approval in October 2023. Attention has been drawn to Vabysmo, a treatment for macular degeneration because it significantly extended the administration interval compared to Bayer's 'Eylea (aflibercept), which has been the standard therapy. In South Korea, Vabysmo's prescription became available after it was approved for reimbursement listing for neovascular age-related macular degeneration (nAMD) and diabetes-related macular edema (DME) in October last year. Existing macular degeneration drugs used in South Korea are vascular endothelial growth factor-A (VEGF-A) drugs such as Novartis' 'Lucentis (ranibizumab),' 'Beovu (brolucizumab),' and Eylea. Unlike existing VEGF drugs, like Lucentis and Eylea, Vabysmo can also block 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. RVO is Vabysmo's third indication. Its efficacy has been confirmed through the Phase 3 BALATON and COMOINO studies. In these two clinical trials, Vabysmo achieved non-inferiority in the patient's vision improvement compared to Eylea. When treated with Eylea, the patients had continual vision improvements from the early stage. The safety profile of the trials was similar to previous study reports. Meanwhile, Vabysmo has seen an increase in sales this year. Its sales for Q1 amounted to 847 million francs, up 88.6% from the previous year. It recorded sales of 947 million francs (about 1.51 trillion won) in Q2, up 86.4% from last year. In Q2, Vabysmo surpassed the sales of the market leader Eylea (about 1.26 trillion won) for the first time.
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- Generic companies seek early entry into KRW 100 bil Tagrisso
- by Kim, Jin-Gu Nov 12, 2024 05:51am
- Patent challenges to Tagrisso (osimertinib), a non-small cell lung cancer treatment that posts annual sales of KRW 110 billion, are expanding. The companies that have filed patent challenges seek to first evade the product patent, which expires in 2035, and then launch generics early after November 2033, when the substance patent expires. According to the pharmaceutical industry on the 11th, Kwangdong Pharmaceutical recently filed a passive trial on the scope of rights against AstraZeneca for the Tagrisso formulation patent (10-2336378). The patent expires in January 2035. In addition to the formulation patent, Tagrisso has two other patents listed on the MFDS Green List. They are the product patents (10-1410902-10-1422619) that expire in November and December 2033, respectively. Kwangdong Pharmaceutical plans to launch Tagrisso generics early upon expiration of the substance patent in 2033, having first avoided the product patent, which expires in 2035. It is also possible that the company could further accelerate the early launch by taking advantage of the extended life of the substance patent. Prior to Kwangdong Pharmaceutical, Chong Kun Dang filed a patent evasion trial on Tagrisso’s product patent on the 25th of last month. With Kwangdong Pharmaceutical joining the patent challenge within 14 business days of Chong Kun Dang’s filing, the two companies have secured the “file of initial claims” requirement, which is one of the requirements for obtaining first generic exclusivity rights. Separately, Chong Kun Dang is developing a new drug for the treatment of non-small cell lung cancer. The candidate, CKD-702, has a dual antibody mechanism of action that simultaneously targets cMET and EGFR, and is currently in a global Phase 1 clinical trial. Chong Kun Dang’s strategy is to target the NSCLC treatment market by developing both new drugs and generics. According to the drug market research institution IQVIA, Tagrisso's sales in the Korean market were KRW 111 billion last year. This is up 4% from KRW 106.5 billion it had posted in 2022. The sales are expected to have increased significantly since the drug's reimbursement was expanded to cover “first-line treatment for locally advanced or metastatic NSCLC with certain gene mutations” this year. Leclaza (lazertinib), whose reimbursement was also expanded to first-line treatment along with Tagrisso, generated KRW 22.6 billion in sales last year.
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- Will Lorviqua be reimbursed as a first-line therapy in KOR?
- by Eo, Yun-Ho Nov 11, 2024 05:49am
- Whether progress will be made in the insurance reimbursement discussions for the ALK antitumor drug Lorviqua is gaining attention. The health authorities recently said they would “promptly start discussions” on the need to expand coverage of the ALK-positive NSCLC drug Lorviqua (lorlatinib) to the first-line. Lorviqua is currently in the process of terminating its risk-sharing agreement (RSA) and has applied for a general listing. Pfizer filed for the general listing shortly after the breakdown of drug price negotiations with the National Health Insurance Service in June, but there was little discussion made on the agenda until recently. At the time, the NHIS said that the drugmaker had expressed its intention to switch Lorviqua’s reimbursement listing status to general listing, which was listed through the pharmacoeconomic evaluations exemption system as an expenditure cap type RSA, but that the switching cannot be discussed as the company’s application falls under extending its reimbursed scope of use. As a result, the negotiations broke down. However, despite the company’s prompt reapplication thereafter, this delay in the simple initiation of the process itself has left patients waiting without reservation. However, this time around, the NA’s criticisms have raised hopes for future developments. The issue is in the regulatory process. Currently, RSA drugs can apply for reevaluation upon the expiry of their RSA term, or start their price-volume agreement negotiations from the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee’s review stage. However, for RSA drug’s reimbursement extensions, no such streamlined track is available. Moreover, since Lorviqua was originally contracted as an expenditure-cap type RSA drug through the pharmacoeconomic evaluation exemption track but is seeking reimbursement through the general listing track, the government having more difficulty shaping the direction. The problem is that the patients are left to suffer the consequences. Regardless of whether the drug’s reimbursement will be extended or not, the government's flexible administration and the will of the pharmaceutical companies would be needed to achieve results. Yool-Seo Cho, Director of the Korean Lung Cancer Patients' Association, said, “We call on the government to actively improve patient access to treatment, including expediting the review of Lorviqua’s reimbursement, so that patients can receive optimal treatment with less emotional distress and financial burden.” Lorviqua was specifically designed and developed by Pfizer to penetrate the blood brain barrier (BBB). The drug’s high clinical value as a first-line treatment was recognized in the 5-year long-term follow-up results of the CROWN study that was presented at ASCO. Results showed that Lorviqua reduced the risk of disease progression or death by 81% compared to crizotinib, with 60% of patients surviving without disease progression at 5 years. The risk of brain metastasis progression was reduced in 94% of patients, with only 4 of 114 Lorviqua-treated patients without brain metastases developing brain metastases.
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- Companies copromote products at Hypertension Seoul 2024
- by Kim, Jin-Gu Nov 11, 2024 05:49am
- Pharmaceutical and biotech companies with hypertension drugs have gathered at the Conrad Seoul Hotel in Yeouido, Seoul on the 8th. Industry officials, who set up promotional booths at the Korean Society of Hypertension's fall conference (Hypertension Seoul 2024), distributed pamphlets to doctors at the event and introduced the features of their hypertension drugs. The Korean Society of Hypertension held its 2024 Annual Meeting at the Conrad Hotel in Seoul from November 8 to 9. The event was held on the 3rd and 5th floors of the hotel. More than 40 pharmaceutical and biotech companies set up booths at the event. According to the Korean Society of Hypertension, more than 700 healthcare professionals attended this year’s event, and a separate space was prepared to reflect on the society’s history as the society celebrated its 30th anniversary this year. Despite the prolonged strike of doctors that began at the beginning of the year, the total number of participants was similar to that of previous years, said an official from the society. “The number of participants is slightly lower than last year,” the official said, adding, ”I know that other conferences with separate sessions for residents have seen a significant decrease in the number of participants. However, the KSH does not have separate sessions for residents, so there is not much difference.” With so many healthcare professionals attending the event, pharmaceutical companies also eagerly promoted their products at the event. A total of 40 companies set up booths at the event to promote their hypertension drugs. Daewoong Pharmaceutical&Daiichi Sankyo and Boryung&HK inno.N, both Diamond level sponsers, opened the largest booths on the third and fifth floors of the venue. Similarly, the platinum-level participants, Organon Korea, Hanmi Pharmaceutical, GSK, and Yuhan Corp, also set up prominent booths on the third and fifth floors. Notedly, there were booths where two companies were promoting one product at the same time. This is analyzed as a result of the increasing number of co-promotion cases in Korea’s hypertension drug market. Currently, Daewoong Pharmaceutical and Daiichi Sankyo are co-promoting the Olmetec (olmesartan) family, Boryung and HK Inno.N are co-promoting Kanarb (fimasartan) family, Dong-A ST and Celltrion Pharmaceutical are co-promoting Edarbi (azilsartan) family, Handok and Sanofi are co-promoting Aprovasc (irbesartan+amlodipine), and Servier and Kolon Pharmaceutical are co-promoting Acertil (perindopril). Many of these companies organized promotional booths together. For example, Boryung and HK Inno.N set up a large booth at the entrance on the fifth floor of the venue. The two companies had signed a copromotion agreement at the end of last year to jointly market Boryung’s Kanarb Family and HK Inno.N’s K-CAB. As a result, HK inno.N has been conducting sales and marketing activities with Boryung since the beginning of this year, targeting frontline hospitals. Setting up the promotional booth at Hypertension Seoul 2024 was also part of the companies’ copromotion strategy. In particular, the companies put much effort into this event, participating as a Diamond sponsor, which is the highest level, for the first time. Boryung and HK Inno.N jointly installed the booth as well. An official from Boryung said, “We have been jointly selling the Kanarb Family with HK Inno.N starting this year, so we jointly set up a promotional booth at Hypertension Seoul 2024. We expect it to be more effective than promoting alone. This way, I believe we will be able to create synergy by utilizing each company’s respective strengths.” A representative from HK Inno.N said, “This is the first Hypertension Seoul 2024 event that we have participated in since starting copromoting Kanarb. We actively communicated with Boryung before the conference to come up with a strategy. Together with Boryung, we have been introducing domestic clinical cases of fimasartan to physicians visiting our booth.” Daewoong Pharmaceuticals and Daiichi Sankyo also jointly promoted the Olmetec family on the third floor. They focused on the fact that Olmetec Family, which celebrated its 20th anniversary this year, is widely used in hypertensive patients with multiple comorbidities. The companies emphasized the effectiveness of Olmetec in controlling blood pressure in elderly hypertension patients, hypertension patients with diabetes, hypertension patients with obesity, and hypertension patients with cardiovascular disease. A company representative said, “We are conducting various campaigns in celebration of the 20th anniversary of the product this year. Many doctors came to the booth to congratulate and encourage us. We plan to build Olmetec’s next 50 years with these supporters.” Dong-A ST promoted Edarbi, which it is co-marketing with Celltrion Pharmaceutical, at the entrance of the third floor. The company emphasized that the azilsartan ingredient of its drug reduced the mean 24-hour systolic blood pressure change more significantly than valsartan. The booths of solo exhibitors also stood out. Hanmi Pharmaceutical promoted Rosuzet and the Amosarrtan family, emphasizing that they are “the No.1 products. On the second day of the event, the company promoted its products during the Luncheon Symposium. GSK attended the Hypertension Seoul 2024 for the first time this year. But interestingly enough, GSK does not own a separate hypertension product. This is in contrast to other companies that have visited the congress with relevant products, such as antihypertensive monotherapy drugs, antihypertensive-hyperlipidemic combination therapy drugs, or a medical device for blood pressure measurement. Nevertheless, GSK didn't just show up, it became a platinum sponsor, the second highest level of sponsorship, and was given a large booth. Instead, GSK promoted its shingles vaccine, Shingrix. GSK emphasized that patients with cardiovascular disease, who are at higher risk for shingles, should be vaccinated with the American College of Cardiology’s recommended dose of Shingrix. “Studies have shown that people with high blood pressure have twice the risk of shingles than people without other medical conditions,” said a GSK representative. The two conditions have a mutually reinforcing effect, with shingles significantly increasing the risk of cardiovascular disease. We came to the Hypertension Seoul 2024 for the first time this year to actively relay these points to doctors who often see patients with hypertension.” The representative added, “We know that many of the doctors who attend Hypertension Seoul 2024 are practicing physicians, and we hope that through today's event, more doctors will be able to recognize the importance of vaccinating patients with hypertension and cardiovascular disease with Shingrix.”
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- 'Voranigo' for malignant brain tumor expected to land in KOR
- by Eo, Yun-Ho Nov 11, 2024 05:49am
- Product photo of Voranigo. 'Voranigo,' a new therapy for malignant brain tumors in over twenty years, is anticipated to be brought to South Korea. Sources said that Servier has recently filed an approval application for Voranigo (vorasidenib). Earlier in September, the Ministry of Food and Drug Safety (MFDS) assigned Voranigo an Orphan Drug Designation (ODD). Voranigo's indication is to treat diffuse gliomas with an isocitrate dehydrogenase (IDH) mutation. Voranigo targets patients with low-grade gliomas who are vulnerable to IDH1 or IDH2 mutations. This drug is a bispecific inhibitor of IDH1/2, developed by multinational pharmaceutical company Servier. It targets glioma (astrocytoma or oligodendroglioma), a type of brain tumor that is difficult to treat. Voranigo received the final approval from the U.S. Food and Drug Administration (FDA) in August and is in the process of getting approved in countries worldwide, including Europe. The efficacy of Voranigo was demonstrated through the Phase 3 INDIGO study. The study results were presented at last year's American Society of Clinical Oncology (ASCO) Annual Meeting. The study results showed that in patients with glioma who have IDH mutation, the drug significantly reduced the tumor progression or death risk by 61% compared to the placebo. Voranigo also reduced the risk of requiring further treatments by 74%. The study participants had no history of undergoing treatments other than surgery. Voranigo also showed favorable drug tolerance. Its safety profile was similar to the Phase 1 clinical trial case results. Meanwhile, glioma is the most common type of primary malignant brain tumor in adults, and almost all adult patients (grade 2 diffuse gliomas) are likely to have IDH1 or IDH2 mutation. These patients are currently treated with off-label (medicines approved for other uses) instead of officially approved medicines. In addition to Voranigo monotherapy, Servier is currently conducting clinical trials for concurrent use of the drug with MSD's immune checkpoint inhibitor, 'Keytruda (ingredient: pembrolizumab),' in patients with relapsed and advanced gliomas who have IDH1 mutation. The company already has 'Tibsovo (IDH1 inhibitor)' and an IDH2 inhibitor in its IDH inhibitor pipeline.
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- K-Bios showcases new ADC drugs on the international stage
- by Son, Hyung Min Nov 11, 2024 05:49am
- The domestic pharma and biotech industry is speeding up the development of new antibody-drug conjugates (ADCs), unveiling their clinical results. At the 'World ADC 2024' that was held in San Diego, U.S. for 4 days from the 4th of this month, domestic pharmaceutical bio companies including Celltrion, LigaChem Biosciences, and ABL Bio revealed ADC research results. With the results, the companies are aiming to secure various solid cancer indications such as non-small cell lung cancer, bladder cancer, and breast cancer. Celltrion seeks to develop a new ADC drug with the Pinotbio platform According to industry sources on the 9th, Celltrion unveiled the preclinical results of its ADC candidate 'CT-P70' for non-small cell lung cancer and 'CT-P71' for bladder cancer and other solid cancer indications for the first time at the conference. The new pipeline unveiled at World ADC utilizes PBX-7016, an ADC platform developed by the ADC company Pinotbio through open innovation. The platform technology is characterized by its enhanced hydrophilicity to increase stability in the blood through the jointly developed payload 'camptothecin derivative,’ and has excellent anti-cancer effects on tumors. ADCs are anticancer drugs made by connecting antibodies that bind to specific target antigens on the surface of tumor cells to cytotoxic payloads with a linker, enabling the drug to selectively act only on cancer cells. This offers the advantage of enhancing therapeutic efficacy while minimizing side effects. With ADC drugs such as Daiichi Sankyo and AstraZeneca's ‘Enhertu,’ Gilead's 'Troldelvy', and Takeda's 'Adcetris' successfully settling in the market, the industry is eyeing the emergence of follow-up drugs. Currently, technology transfer and clinical trials for the next ADC are actively underway in global and domestic pharmaceutical companies. CT-P70 is an ADC drug targeting solid cancers such as non-small cell lung cancer. It targets 'c-MET', which causes tumor growth when activated in cancer cells. C-MET is a protein expressed by the epithelial-to-mesenchymal transition (MET) gene. It is one of the proteins that transmit signals to cells and is considered a typical cancer-inducing gene and is associated with the development of various solid cancers, including colorectal, gastric, and liver cancers, as well as lung cancer. It is estimated that 6% of patients with NSCLC have c-MET mutations. In preclinical studies, CT-P70 has shown tumor inhibition effect in c-MET-expressing lung and gastric cancers in vitro and in vivo, with confirmed safety in toxicity studies. There are currently no ADCs targeting c-MET available on the market, but AbbVie presented promising Phase II trial results last year. Based on the Phase II trial results, AbbVie has applied for accelerated approval with the U.S. Food and Drug Administration (FDA). CT-P71, which Celltrion also presented the same day, is an ADC drug in development for the treatment of solid tumors, including bladder cancer, that targets nectin-4, a cell surface protein that is overexpressed in solid tumors. It has shown efficacy in tumor inhibition in bladder, breast, and lung cancers in nonclinical studies and an excellent safety profile in toxicity studies. Currently, the only ADC drug that targes nectin-4 is Astellas' Padcev. The drug is currently approved for urothelial carcinoma and is being studied in several solid tumors. Celltrion plans to develop CT-P70 and CT-P71 as best-in-class drug candidates. ABL Bio-LigaChem Biosciences announces ADC clinical trial results ABL Bio and Ligachem Biosciences, which have a diverse pipeline of ADC drug candidates, also attended the event. LigaChem Biosciences unveiled the features and safety results of its ADC platform 'ConjuAll'. ADCs consist of a linker, payload (drug), and antibody, and the ConjuAll linker is said to be able to overcome the release of cytotoxic drugs into the blood and attack normal cells. Currently, LigaChem Biosciences has three drug candidates in clinical trials - LCB14, LCB84, and LCB71. LCB14 is an ADC that targets HER2 and is currently in Phase II/III clinical trials in China and Phase I trials in Australia. LigaChem Biosciences has licensed out LCB14 to China-based Fosun Pharma UK-based Iksuda Therapeutics. The two companies are conducting clinical trials in China and Australia, respectively. LCB84, a Trop2-targeting ADC, was licensed out to Janssen. LCB84 is an ADC drug candidate with the potential to target a variety of solid tumors, including triple-negative breast cancer and non-small cell lung cancer. In preclinical studies, LCB84 has shown efficacy in solid tumors refractory to topoisomerase payload-based TROP2 ADC drugs. LCB71 is currently in Phase I clinical development. LCB71 is an ADC candidate that targets hematologic malignancies. Currently, LigaChem Biosciences’ partner in China, Cstone, has selected LCB71 as its core clinical program and plans to initiate a Phase Ib clinical within the year. ABL Bio presented non-clinical trial data from its bispecific ADC pipeline. The two drug candidates it presented were found to be well-tolerated and safe in preclinical studies. ABL Bio is developing ABL201, an ADC candidate targeting hematologic cancers, and ABL201 and ABL202 targeting solid tumors. ABL has successfully licensed out ABL201 to a biotech venture TSD Life Sciences. Also, ABL202 is being developed in collaboration with LigaChem Biosciences’ linker technology. The company aims to enter clinical trials for three of its bispecific ADCs, including the one in preclinical trials.
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- 20-valent pneumococcal conjugate vaccine to enter market
- by Whang, byung-woo Nov 08, 2024 05:47am
- The pneumococcal vaccine market, which has shifted with the introduction of a 15-valent vaccine this year, is expected to again face fierce competition with the approval of a new 20-valent vaccine. Pfizer, which is about to launch a new product, plans to replace the share of its existing product, Prevenar 13 with its new product, Prevenar 20. In the process, MSD, which has been gaining market share since the launch of Vaxneuvance, will also be facing increasing challenges to secure its sales. (From the left) Product photos of Vaxneuvance and Prevenar 20 According to industry sources on the 7th, the Ministry of Food and Drug Safety recently approved Pfizer's ‘Prevenar 20 Prefilled Syringe' (Prevenar 20). Prevenar 20 is Pfizer's first new pneumococcal vaccine in 14 years, which adds 7 serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F) to the existing Prevenar 13 vaccine. It can be used to vaccinate infants, children, and adolescents aged 6 weeks to 18 years and adults aged 18 years and older. Prevenar 20 is expected to be released in the first half of next year, given that Vaxneuvance was approved a year ago on Oct. 31, 2023, and then released to market in April the following year. A Pfizer spokesperson said, “We are currently working with multiple stakeholders to expedite all processes to accelerate the launch of Prevenar 20. We will share more details as soon as we have a specific launch timeline.” Prevenar 13 was sold in partnership with Chong Kun Dang for adults and Korea Vaccine for pediatric use. Industry insiders believe that these two companies will have priority in discussing the distribution of Prevenar 20. If there is one variable in terms of timing, its entry into the National Immunization Program (NIP) would likely be the variable. Currently, pediatric pneumococcal vaccines are included in the NIP, and both Prevenar 13 and Vaxneuvance are available through the program. Last year, Vaxneuvance passed the Korea Disease Control and Prevention Agency’s Korea Expert Committee on Immunization Practices within a month of its approval, expanding its market influence by applying the pediatric NIP upon its launch. In fact, Jae-Yong Cho, executive director of vaccine business at MSD Korea, said at a recent media seminar that “Both the initial vaccination cases using Vaxneuvance for infants and young children under the NIP, as well as cross-dosing cases where subjects are switching from the existing 13-valent vaccine to Vaxneuvance, have been increasing.” Pfizer is also reportedly in discussions with the KDCA about applying pediatric NIP to Prevenar 20 to gain competitiveness. “Pediatric pneumococcal vaccination covered by the NIP, so Pfizer has no choice but to enter the NIP to make Prevenar 20 competitive,” said a vaccine industry insider. ”We understand that they are currently in discussions with the KDCA, but whether the drug will be included in the NIP will depend on how Pfizer sets the price.” The industry's view is that if the discussions between the KCDA and Pfizer go smoothly, it could lead to a quick launch, but if there is a big disagreement on the price, the pharmacoeconomic evaluation process will be inevitable, changing Pfizer's prompt introduction strategy. Prevenar 13 and Vaxneuvance compete in clinics in Korea “We are making our best efforts to promptly introduce Prevenar 20 into the National Immunization Program. We are working closely with relevant departments to prepare the necessary procedures,” said a Pfizer representative. Apart from the pediatric NIP entry, pricing is also expected to be a key issue in the adult market, as a non-reimbursed launch is certain in the area. In the current market, Vaxneuvance is only slightly more than Prevenar 13. The successor to Prevenar 13, Prevenar 20, is expected to be a little more expensive. Upon its launch, the company had been running TV commercials to build brand awareness for Vaxneuvance. The company has also been emphasizing immunogenicity, which is as important to the vaccine's effectiveness as the scope of protection.
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- Optivo's clinical results for Koreans with gastric cancer
- by Son, Hyung Min Nov 08, 2024 05:47am
- Product photo of the immunotherapy Optivo. Optivo, an immunotherapy used to treat certain types of cancer, showed a positive result in gastric cancer clinical trials that involved Koreans. The study demonstrated a 47% reduction in the disease progression and death risk compared to conventional therapies. According to industry sources on November 6th, Bristol Myers Squibb (BMS) and Ono Pharmaceutical have recently presented the subgroup analysis results from Phase 3 'ATTRACTION-4,' evaluating Optivo as a treatment for East Asian patients. The clinical trial involved 724 patients with HER2-negative gastric cancer, including 291 Korean patients. The study evaluated Optivo in combination with platinum-based chemotherapy as a first-line treatment for patients compared to a combination therapy of placebo plus platinum-based chemotherapy. Based on the clinical result, Optivo combination therapy's benefit of improving progression-free survival (PFS) was prominent in the Korean patient group compared to those from other countries. In detail, the Korean subgroup's median PFS was 14.8 months for Optivo combination therapy and 8.3 months for placebo, showing 47% lower disease progression and death risk with Optivo combination therapy. The objective response rate (ORR) was 54.7% for the Optivo combination therapy group, which was higher than the placebo group's. The median duration of response (DOR) was 16.0 months for the Optivo combination therapy group, which was longer than the 9.9 months for the placebo group. In the total patient group, about 80% of the patients who showed complete response (CR) in the Optivo combination therapy group survived over three years. New safety-related adverse reactions associated with Optivo combination therapy had not been reported. In a retrospective clinical analysis conducted in Asan Medical Center involving patients with advanced gastric cancer who also have advanced deficient mismatch repair (dMMR), patients treated with Optivo combination therapy had a 12-month PFS of 69.4%, which was longer than 20.6% for the placebo group. "The subgroup analysis from the ATTRACTION-4 study, which enrolled many Koreans, showed that Optivo combination therapy yielded positive data during about three years of follow-up. This study results support the treatment effects of Optivo combination therapy, currently listed as a reimbursable first-line treatment for HER2-negative advanced or metastatic gastric cancer," Hyung-Don Kim, a Professor of the Department of Oncology at Asan Medical Center in Seoul, said. Optivo is the only reimbursable drug among immunotherapies…has been established as a standard therapy In South Korea, Optivo was approved in June 2021 as a first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for patients with advanced or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, or esophageal adenocarcinoma. It was listed for reimbursement last year. The average OS was below 1 year for HER2-negative patients, about 80% of advanced·metastatic cancer, who received conventional chemotherapy as a first-line treatment. Compared to immunotherapy for cancer, several targeted therapies used in clinical trials as a first-line treatment had not shown significant clinical benefits. The treatment practices for HER2-negative advanced gastric cancer started to change following the introduction of a treatment strategy of using an immunotherapy agent in combination with conventional chemotherapy. Optivo is now established as a standard therapy after becoming the first immunotherapy to win approval for the indication to treat advanced·metastatic gastric cancer as a first-line treatment in combination with chemotherapy. The basis for Optivo combination therapy used as a first-line treatment of advanced gastric cancer was the Phase 3 CheckMate-649 study, which showed relatively high ORR and longer DRR compared to single chemotherapy in all patient groups, including patients with below PD-L1 CPS 5. Such treatment benefits were repeated in the fourth-year follow-up results presented at the ASCO Gastrointestinal (GI) Cancers Symposium (ASCO GI), held in January. The clinical results showed that the Optivo combination therapy group's below CPS 5 patient group had an ORR of 55%. Optivo combination therapy provided an OS benefit for the patient group accompanying microsatellite instability-high (MSI-H) regardless of the PD-L1 expression rate. "Gastric cancer is a type of cancer with the highest prevalence in South Korea, but Korean patients faced difficulties because of limited treatment option availability," Professor Kim said. "As Optivo combination therapy has demonstrated OS extension in HER2-negative gastric cancer as the first first-line combination therapy, it is meaningful because it provides a treatment option with long-term survival goal." "With reimbursement listing, many patients could benefit from Optivo combination therapy over a year. It might have brought positive changes to the survival rate of advanced or metastatic gastric cancer," Professor Kim added.
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- Geo-Young and UBC Korea sign MOU to distribute Bimzelx
- by Son, Hyung Min Nov 08, 2024 05:47am
- (from the left) Sujin Hwang, General Manager of UBC Pharm, Sun-Hae Cho, Chairwoman of Geo-Young. Geo-Young announced today that it has signed a Memorandum of Understanding with UBC Korea to distribute Bimzelx. Under the agreement, Geo-Young will carry out the entire distribution process from storage to supply of Bimzelx. Bimzelx is a treatment for plaque psoriasis that simultaneously and directly targets and inhibits interleukin 17A and 17F (IL-17A·IL-17F), protein immunomodulators that drive inflammation in psoriatic disease. On August 29, Bimzelx the Ministry of Food and Drug Safety approved Bimzelx as a treatment for adult patients with moderate-to-severe psoriasis who require phototherapy or systemic therapy. Through this distribution agreement, Geo-Young plans to commit itself to ensuring a stable supply of Bimzelx in Korea. In multiple clinical trials, including in South Korea, Bimzelx demonstrated higher levels of Psoriasis Area and Severity Index (PASI) 100 achievement rates than existing biologics. PASI, which stands for Psoriasis Area and Severity Index, is a key efficacy endpoint for psoriasis treatments, and Bimzelx’s PASI 100 achievement rate was maintained at a high level for three years in an open-label extension study. “As the leading drug distributor in Korea, we will do our best to provide prompt and accurate supply of Bimzelx and contribute to the treatment of psoriasis patients,” said Sun-Hae Cho, Chairwoman of Geo-Young. ”We will continue to take initiative in improving public health through the active distribution of excellent medicines.” “We are very pleased to take the first step towards the launch of Bimzelx with Geo-young, following the approval of Bimzelx by the MFDS in August,” said Sujin Hwang, General Manager of UBC Pharm. ”We hope that the stable supply of Bimzelx will help many psoriasis patients in Korea experience the therapeutic benefits of Bimzelx.”
