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- 2026-04-12 18:23:58
- Policy
- Actemra is likely to be reimbursed for managing CRS
- by Kim, Jung-Ju Mar 21, 2022 05:55am
- Actemra (Tocilizumab 200mg), imported by JW Pharmaceutical and used to treat rheumatoid arthritis, is also expected to be paid for CRS management. The MOHW announced on the 18th some amendments to the "Details on the Application Criteria and Methods of Nursing Benefits" containing such contents. Actemra is a drug approved for adult rheumatoid arthritis treatment, systemic childhood idiopathic arthritis, and multi-articular childhood idiopathic arthritis. CRS develops symptoms due to excessive release of cytokines from immune cells in the process of killing cancer cells. The MOHW plans to recognize benefits when administering Actemra to CRS management. The government plans to conduct an industry opinion inquiry by the 27th with the aim of implementing it on the 1st of next month. Meanwhile, Actemra recently received EUA from the MFDS to be used for the treatment of severe COVID-19 patients over the age of 2. The drug is approved as a COVID-19 treatment in the United States, Japan, and Europe.
- Policy
- In/outpt Rx for Paxlovid are available in nursing hospitals
- by Lee, Jeong-Hwan Mar 21, 2022 05:55am
- Nursing hospitals will be able to prescribe outpatient & inpatient Rx for Paxlovid, a COVID-19 treatment. Both outpatient prescriptions that prepare and supply oral drugs at pharmacies in charge and inpatient prescriptions that receive oral drugs from hospitals dedicated to infectious diseases that supply treatments have become possible. The KDCA made the announcement at a regular briefing on the 17th. The KDCA judgment that group infections in nursing hospitals are continuing and timely administration of PO treatments for the elderly affected the permission of outpatient & inpatient prescriptions in nursing hospitals. Kim Ok-soo, head of the resource management team at the quarantine countermeasures headquarters, explained, "The nursing hospital originally tried to prescribe Paxlovid as outpatient Rx, but there was a shortage of supplies at pharmacies in charge of cities, counties and districts. Team leader Kim Ok-soo added, "The nursing hospital has improved the system since the 14th so that inpatient and outpatient Rxs can be made in a timely manner," adding, "It is a new application." Since the 14th, KDCA has taken measures to prescribe Paxlovid, a treatment to be taken when training rapid antigen tests, for those aged 60 or older, and it is necessary to secure the amount of treatment. According to the KDCA, Paxlovid for 163,000 people was supplied to Korea as of the 16th, and the inventory was 96,000 people. In addition, it is scheduled to be introduced in Korea at the end of March. The KDCA said, "We will promote the prevention of seriousness and the burden of the medical system through active administration to the elderly," adding, "We will ensure that timely administration of treatments can be made."
- Policy
- Oral myeloid leukemia treatment Onureg to be soon approved
- by Lee, Hye-Kyung Mar 18, 2022 05:56am
- The domestic marketing authorization for BMS’s acute myeloid leukemia (AML) treatment, ‘Onureg tablet (azacytidine).’ Is imminent. The safety and efficacy review for the marketing authorization of Onureg, which had received FDA approval in 2020, is now complete in Korea. According to industry sources on the 16th, the Ministry of Food and Drug Safety has completed verification on the efficacy of Onureg that BMS Korea had submitted an application for. With the safety and efficacy review complete, experts expect Onureg, the first oral azacytidine, to be released within the first half of this year. The AML treatments currently approved in Korea are Celgene’s ‘Vidaza inj.100mg,’ Boryung Pharmaceutical’s ‘Vizadakin Inj.,’ Samyang Holdings’ ‘Azalid inj. 100mg,’ and ‘Azalid inj. 150mg.’ All of the motioned drugs are injection types, therefore, if approved, Onureg will become the first oral treatment formulation to be approved in Korea. Hypomethylating agents, which are also known as CC-486, are used to treat adult AML patients who achieved CR or CRi following induction therapy with or without consolidation treatment and who are unable to complete intensive curative therapy such as HSCT. Warning and precaution for Onureg include risks of substitution with other azacitidine products, myelosuppression, increased early mortality in patients with myelodysplastic syndromes, and embryo-fetal toxicity.
- Company
- K-Bio has become a global production hub
- by Kim, Jin-Gu Mar 18, 2022 05:55am
- The Korean pharmaceutical bio industry has become a global coronavirus vaccine and treatment consignment production hub. With the consignment production of coronavirus vaccines and antibody treatments in charge, the company will be in charge of consignment production of oral treatments for the supply of underdeveloped countries. On the 17th, the MOHW announced that Celltrion and DongbangFTL were selected as generic producers of the oral corona treatment Paxlovid developed by Pfizer. Celltrion produces finished products and DongbangFTL produces Nirmatrelvir. The products produced here are supplied to 95 underdeveloped countries. MPP, along with two Korean companies, selected a total of 35 companies from 12 countries around the world. There are 19 in India, 5 in China, 1 in Bangladesh, Vietnam, Brazil, Dominican Republic, Mexico, Jordan, Israel, Serbia and Pakistan. In January, International Pharmaceutical Patent Pool also selected three Korean companies as generics of the oral coronavirus treatment developed by MSD. Hanmi Pharmaceutical was selected along with Celltrion and DongbangFTL. Ildong Pharmaceutical is jointly developing another oral treatment candidate material "S-717622" with Shionogi of Japan. Ildong Pharmaceutical plans to produce oral treatments with Shionogi and supply them globally as soon as the clinical trial is completed. It is interpreted that the stable production capacity of Korean companies has been verified by the world over the fact that they have been selected as a producer of oral treatments one after another. Korean pharmaceutical companies are being used as consignment production bases for COVID-19 vaccines and antibody treatments by multinational pharmaceutical companies. In the case of COVID-19 vaccines, five domestic companies have decided to commission production of five global vaccines. SK Bioscience has been producing AstraZeneca and Novavax vacine since last year. Samsung Biologics has signed a contract with Moderna and is producing a coronavirus vaccine. Although it has not yet begun full-scale supply, the Korus Pharm consortium can commission Russian vaccine Sputnik V, while Hanmi Pharmaceutical and Enzychem can commission ZyCoV-D developed by Indian pharmaceutical company Zydus Cadila. In addition, Samsung Biologics is commissioned to produce AstraZeneca Evusheld and Eli Lilly's Bamlanivimab, which are corona antibody treatments. Celltrion has produced and is supplying its own antibody treatment drug Regkirona globally. At the end of last year, it was approved for use in Europe. An official from the pharmaceutical industry said, "Korea has large-scale facilities for consignment production and has high reliability in quality. With the Corona incident, the status of the Korean pharmaceutical bio industry will increase, and the value of the K-bio brand will also increase on the global stage in the future."
- Company
- Largest shareholder of Medipost changed to a private equity
- by Chon, Seung-Hyun Mar 18, 2022 05:55am
- View of Medipost HQ The largest shareholder of the bio venture company Medipost will be changed from the founder and CEO Yoon-sun Yang to a private equity consortium. Medipost plans to receive an investment of approximately ₩140 billion from a private equity fund to invest in its cell and gene therapy business. On the 17th, Medipost announced that it had signed an investment agreement worth ₩140 billion with Skylake Equity Partners and Crescendo Equity Partners. Under the agreement, Medipost will issue a paid-in capital increase through a third-party allotment worth ₩70 billion to Skylake and Crescendo. A total of 374,314 shares will be newly issued. Medipost will issue registered non-guaranteed private Equity Convertible corporate bonds worth ₩35 billion each to Skylake and Crescendo. Skylake and Crescendo etc. will be investing ₩140 billion just in paid-in capital increase and convertible bonds alone. Medipost’s largest shareholder had been CEO Yoon-sun Yang, who had owned 1,001,002 shares (6.16%). However, with the capital increase alone, the number of shares owned by Skylake and Crescendo exceed the number owned by CEO Yang, thereby changing the largest shareholder of the company. In addition, Yang had transferred 400,000 shares to Skylake, etc. at ₩90 billion. When the conversion of convertible bonds to common stocks is complete in addition to the paid-in capital increase the shares bought, Skylake, etc. will own 32.7% of Medipost’s shares. In total, Skylake, etc. is investing ₩230 billion for the acquisition of Medipost shares. Medipost plans to invest ₩85 billion of the secured funds in gene cell therapy CDMO company based in the North American region. Currently, Medipost is in exclusive negotiations with a CDMO company to sign an investment agreement within May this year. The company plans to invest 55 billion won in clinical trials conducted for the osteoarthritis treatment Cartistem and SMUP-IA-01 in the US to accelerate its entry into the US osteoarthritis treatment market. Medipost has pointed to the CDMO business for gene cell therapy as the optimal new The company expects that the business will serve as a production base that can produce and supply clinical regents for Cartistem and SMUP-IA-01 in the US, as well as efficiently manage the manufacture and supply of the company’s products after marketing approval. A Medipost official said, “This funding is significant in that we were able to secure a shareholder who can actively support overseas businesses, based on which we could aggressively promote businesses overseas and maximize corporate value.” An official from Skylake said, “We evaluated Medipost's global potential for global expansion highly as the company owns world-class stem cell screening and culture technology and promising stem cell therapies such as Cartistem, and decided to invest in the company in consideration potential and synergy that will be made with the global cell gene therapy CDMO business and growth." An official from Crescendo said, “We decided to invest in Medipost because we were confident that Medipost could grow into a global champion with Crescendo's overseas business experience and global network, including our ties in the US.” Skylake and Crescendo’s investment will be safeguarded in a depository for one year.
- Company
- Multinational pharmaceutical companies are changing logos
- by Mar 18, 2022 05:55am
- Organon Korea returns after 13 years of absence with a new logo, "Women's Health" starts anew. Multinational pharmaceutical companies are trying to transform their image with new logos. Pfizer entered the unexplored area of mRNA and changed its logo in about 70 years. Sanofi also emphasized "one Sanofi" as an integrated brand logo. Analysts say that multinational pharmaceutical companies are expressing the spirit of science and innovation with new logos as they jump into areas where it is difficult to develop treatments. Sanofi-Aventis Korea announced on the 15th that it will remove the separate brands attached to each division and merge them into a single brand. Until now, the vaccine division has been called Sanofi Pasteur and the specialty care division has been called Sanofi Genzyme. In the future, Pasteur and Genzyme will be excluded and all will be integrated into "Sanofi." However, the existing corporations divided into Sanofi-Pasture and Sanofi-Aventis are not integrated. Old Sanofi logo (left) and New logo (right) The intention is to unite distributed brands and present common goals and identities. Founded in 1973, Sanofi has included companies it has acquired, including Sanofi-Synthelabo, Aventis, and Genzyme, in its business team brand names. Then, in 2019, it announced the improvement of the constitution of the new drug pipeline and began to change. It will boldly give up pipelines with poor growth engines such as chronic diseases and invest heavily in new growth fields such as immunity, rare diseases, and nervous system diseases. In other words, Sanofi's four business units ▲ Sanofi Pasteur (vaccine) ▲ Sanofi Genzyme (specialty care) ▲ General Medicine ▲ Consumer Healthcare is a plan to integrate and expand Pasteur and Genzyme. The logo has also been transformed as part of the first brand integration in Sanofi's history. The new shape, which means innovation, adaptation, and growth, has changed the existing logo, which used to form a circle, to a lowercase logo with two purple dots at the beginning and end of the name. The new logo is inspired by the simple yet dynamic nature of the tech industry. The purple dot on S means the starting point for asking the question What if? The purple dot of i is the end point that results in the discovery of innovative solutions. The new logo represents Sanofi's scientific journey from the starting point to the ending point. Sanofi said, "In the future, we will think and move as a company under a new and common purpose and identity," adding, " we hope the new integrated brand unveiled this time will serve as an opportunity to inform employees, partners, medical experts and patients of Sanofi's identity and orientation." The old Pfizer logo (left) and the new logo (right) Pfizer, which is improving its constitution to develop innovative new drugs, also introduced a new logo for the first time in 70 years. The pill-shaped oval background, which has been representative of Pfizer, has been boldly discarded. The new logo represents a double helix with two tones of blue bands symbolizing Pfizer. This means that the substance of double helix is revealed by unlocking the original pill form. The logo extending upward conveys an upward movement, and the rotating form means "reversing the old reality for innovation." Pfizer, which planned to spin off its patent expiration division and change its logo, finally selected a design produced by Brooklyn Studio Team in the U.S. Just in time, Pfizer succeeded in transforming its image by introducing the COVID-19 vaccine. Pfizer, which commercialized the mRNA-based vaccine for the first time, has also drastically trimmed its pipeline to suit the new logo. It has begun to develop mRNA-based drugs in earnest. mRNA-based drugs are a new mechanism that has just begun commercialization, and there are still many unexplored areas. Old organon logo (left) and new logo (right) Organon, which was spun off from MSD, has started to break away from its past image with a new logo. Founded in the Netherlands in 1923, Organon is the place where the early substance of the immuno-cancer drug Keytruda was developed. It has a history of being absorbed into MSD through a merger with Schering-Plough. About 10 years later, it was separated from MSD again and reborn as an independent corporation. Organon, which focused on women's health in the past, focused on three areas: women's health after independence, chronic diseases, and biosimilars. The name Organon Korea is the same, but it changed the logo in the sense of starting anew. Unlike the old logo, which was a turquoise oval band, the new logo has a circular point in green, blue, and sky blue and a scarlet dash pattern forming a geometric pattern. The central dot means women's health, and the surrounding dots indicate that the company is paying attention to various environments that affect women's health. The dash pattern contains a commitment to improving human life, a vision for a healthier life for all women, and a mission to supply meaningful medicines. The geometric pattern created by gathering dots and dashes means that the company's appearance today and its vision for tomorrow communicate and integrate with each other. Organon Korea said, "In the past, Organon Korea has also made a lot of innovations in women's health," adding, "The new Organon Korea will provide new solutions for women's health, which was relatively unmet."
- Company
- Same ‘one-shot’ but different? Zolgensma reimb slow
- by Eo, Yun-Ho Mar 17, 2022 05:59am
- Although both drugs are from the same pharmaceutical company and are both one-shot, high-priced drugs, the two drugs are showing a stark difference in their results. Discussions on the reimbursement listing for Novartis Korea’s Zolgensma (onasemnogene abeparvovec) is not progressing so smoothly. The company had applied for the reimbursement listing of its Spinal Muscular Atrophy (SMA) treatment Zolgensma in May last year through the approval-benefit appraisal linkage system, but the agenda has not been deliberated by the National Health Insurance Service DREC until now. As it is a rare disease drug, the Drug Reimbursement Standard Subcommittee must set reimbursement standards, and the drug pass DREC deliberations to receive reimbursement. According to industry sources, the government had numerously requested data supplementation to the company, upon which the company repeatedly submitted additional data. Originally, drugs should receive DREC deliberations within 150 days of submitting an application under the National Health Insurance Act, but this period has long been exceeded. This is different from the results made for the company’s new CAR-T therapy ‘Kymriah (tisagenlecleucel).’ Kymriah has passed DREC deliberations last January. Last month, Yong-Myung Jang, HIRA’s Director of Development at the Health Insurance Review and Assessment Service (HIRA) mentioned Zolgensma at a press meeting with the Special Press Corp last month, raising hopes on the progress to be made for Zolgensma. Director Jang said, “We have collected opinions from the society, experts, and held an expert advisory meeting to discuss its clinical use. DREC deliberations are in the way for the drug.” However, Zolgensma was not on the list for deliberations in February. Meanwhile, Zolgensma is a gene therapy that contains a genetic material that functionally substitutes defective genes. The Ministry of Food and Drug Safety approved Zolgensma as the second advanced biologic product after Kymriah. Advanced biopharmaceuticals are cell therapies or gene therapies that use live cells, tissues, or genetic material as ingredients. Under the ‘Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals,’ advanced biopharmaceuticals can receive differentiated safety management including long-term follow-up studies and support for R&D and product commercialization. Despite being a one-shot treatment, the price of the single shot costs 2.5 billion won in the U.S. and 1.89 billion won in Japan. Due to the high price, the listing process for Zolgensma in Korea is also expected to walk a rocky road However, expectations for its efficacy are very high. The Phase III SPR1NT and STR1VE-EU results for Zolgensma that was presented recently gained much attention. In the SPR1NT study, all pediatric SMA patients with two SMN Type 2 gene copies (Cohort 1) that were treated presymptomatically survived without requiring ventilatory or nutritional assistance and achieved sitting independently for 30 seconds or more. Most (11/14) patients achieved age-appropriate motor milestones within the World Health Organization (WHO) window of normal development. In the STR1VE-EU study, most pediatric patients (82%) that were treated with Zolgensma, including those with severe SMA, achieved motor milestones unseen in the natural history of SMA Type 1. An official from the company said, “Patients and their families are longing for the prompt reimbursement of Zolgensma. We are working closely with relevant ministries so that we can receive reimbursement as soon as possible and not deprive the opportunity for patients desperately waiting to be treated with Zolgensma.”
- Company
- Molnupiravir can be supplied on the day of approval
- by Mar 17, 2022 05:58am
- MSD is trying to contribute a lot to overcoming the COVID-19 pandemic. Molnupiravir is fully prepared to be supplied on the same day as soon as it is approved. Kevin Peters, CEO of MSD Korea, made the remarks at a press conference held on the 16th. MSD developed the COVID-19 treatment Molnupiravir last year and received the U.S. Food and Drug Administration (FDA) EUA in December of that year. This is the second COVID-19 treatment after Pfizer's Paxlovid. 13 countries, including the UK, Japan, Australia and Taiwan, approved the use of Molnupiravir. The WHO has included Molnupiravir as a treatment option in the revised COVID-19 treatment guidelines. In November last year, MSD also applied for EUA of Molnupiravir to the MFDS. However, it has not been approved even after about three months. This is in contrast to the approval of Paxlovid, which filed an application at the same time, in about a month. Some point out that Molnupiravir's effectiveness fell short of expectations as a result of clinical trials. In phase 2/3 conducted by MSD, Molnupiravir reduced hospitalization and death risk by about 30%. Paxlovid had up to 89% effect in its own clinical practice. For this reason, the FDA advisory committee also considered whether to approve Molnupiravir. Although they managed to recommend approval, 10 people, or 40%, opposed it. Regarding the progress of approval of Molnupiravir, CEO Peters said, "I think both vaccines and treatments should provide as many options as possible to effectively overcome the pandemic." Molnupiravir is used in many countries around the world, contributing a lot to treatment, he said. He then said, "MSD is cooperating as much as possible so that Molnupiravir can be used quickly," adding, "What I can promise is that it can be supplied immediately as soon as approval is given. We are fully prepared to supply it from the day of approval."
- Company
- Verzenio makes "bid with verified data” against Ibrance
- by Mar 17, 2022 05:58am
- The breast cancer treatment ‘Verzenio’ is working hard to expand its market. Although it is a latecomer in the CDK 4/6 inhibitor market, Lilly is showing confidence that it can bring different results from other previous treatments. In fact, Verzenio is pioneering the base of use of CDK4/6 inhibitors from metastatic breast cancer to early breast cancer based on its powerful data. The cyclin-dependent kinases (CDK) 4/6 inhibitors that control cell division and growth selectively inhibit the proliferation of cancer cells. The drugs target human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, which accounts for 60% of all breast cancers. The drug that had opened the door to the CDK 4/6 inhibitor market was ‘Ibrance (Palbociclib).’ After it was introduced in August 2016, the drug became namely ‘the' breast cancer treatment. In this sense, the market was formidable for the latecomer Verzenio (abemaciclib), which was approved in May 2019, because of the solid position established by Ibrance during the past three years. Also, the misconception that “all CDK4/6 inhibitors are same” and the introduction of the third CDK4/6 inhibitor,‘ Kisqali (ribociclib),' had intensified competition in the market. However, Lilly is showing extreme confidence in Verzenio. In an interview with Dailypharm, Jihee Kim, a Sr. Brand Manager for Verzenio at Lilly Korea, said, “Verzenio has shown consistent effect regardless of the patient's menopausal status, and extended overall survival (OS) in patients who were known to have a relatively poor prognosis. Its molecular structure is slightly different from the other two drugs, which makes differences in efficacy, side effects, and administration period. This is why Verzenio is preferred in treating patients with poor prognosis." Results of the MONARCH-2 trial that allowed for the approval of Verzenio showed that the use of the Verzenio+fulvestrant combination demonstrated a significantly longer median overall survival (OS) of 46.7 months compared to the median OS of 37.3 months with fulvestrant monotherapy. The primary endpoint, median progression-free survival (PFS) was 16.4 months vs 9.3 months. Significant results were also obtained from its sub-analysis. Verzenio had shown consistent prolongation effects in breast cancer patients with poor prognosis such as those with liver metastasis or high-grade tumors, progesterone receptor-negative patients, and those with metastasis in other areas than the bone. These study data were also positively received by the clinical field and are making an impact. Sales of Verzenio had surged after its reimbursement listing in June 2020 (based on IQVIA), raising ₩11.2 billion last year. This is a 136% rise YoY. Its sales are still far below Iblance’s sales of ₩65.6 billion, but is considered to be a smooth start. Also, the hidden efforts of the marketing team had shone through. Sr. Manager Kim said, “Not many doctors were aware of the latecomer Verzenio at the time, and it was difficult to change the prescription pattern of the doctors as the doctors regarded all CDK4/6 inhibitors the same. To overcome this, we have actively conducted symposiums and product briefings. Among the healthcare professionals who attended our briefings, some hed given feedback that they would consider prescribing our drug to eligible patients and prescribed them. I felt proud that we were able to deliver the value of Verzenio all the way to the patient." Also, another characteristic of Verzenio is that it is the only CDK 4/6 inhibitor that does not require a "treatment holiday." CDK 4/6 inhibitors are taken for 2 years at the longest, and therefore the management of its side effects in the early stages is very important. Also, regular toxicity monitoring is essential in the early stages of administration is also essential. Other drugs have a 1-week break period after 3 weeks of administration, therefore when these drugs are discontinued due to side effects, this period is extended, causing difficulties in toxicity management. On the other hand, management of the daily-taken Verzenio is much simpler. If a side effect arises, the patient may temporarily discontinue taking the drug and restart use after dose adjustments or the same dose as needed. Verzenio can also expand the field covered by CDK4/6 inhibitors, as it has acquired positive data in early breast cancer. Verzenio achieved its primary endpoint in an average follow-up period of 15.5 months as adjuvant therapy in patients with early HR+/HER2- breast cancer. Although its indication has not been extended to breast cancer in Korea yet, expectations are high among HCPs in the field on the use of CDK4/6 inhibitor in early breast cancer. Until then, it is most important for HCPs to use Verzenio in metastatic breast cancer and learn for themselves the characteristics of the drug and establish trust in the drug.
- Policy
- EUA approval of Actemra for severe COVID-19 over 2 yrs
- by Lee, Hye-Kyung Mar 17, 2022 05:58am
- Actemra can be used in severe COVID-19 patients over the age of 2. The MFDS (Director Kim Kang-rip) announced on the 15th that it approved EUA of Actemra imported by JW Pharmaceutical for severe COVID-19 patients aged two or older to prevent a shortage of treatments in advance. The seriousness referred to herein refers to hospitalized patients who are receiving systemic corticosteroid and need oxygen therapy. The MFDS comprehensively reviewed related data and results of consultation with infectious medicine specialists, and decided EUA after deliberation by the Public Health Crisis Response Medical Product Safety Management and Supply Committee. Actemra is effective in treating severe COVID-19 patients and is used with EUA (USA) or permission (Europe, Japan). Actemra is an antibody drug (more than 60 minutes of intravenous administration) that has already been licensed and used as a treatment for rheumatoid arthritis in Korea. The MFDS said, "We will continue to do our best to quickly supply safe and effective products to overcome COVID-19 and restore the people's daily lives."
