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- 2026-05-11 16:20:58
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- MSD’s Keytruda becomes the 'symbol' of cancer immunotherapy
- by Eo, Yun-Ho Aug 25, 2021 05:57am
- Pic. of Keytruda “Reinforcing the body’s immunity to attack cancer cells” By some, the idea was regarded improbable. Not many were convinced that immunotherapy would rise to the position it is in now. Even without reference to the famous story of how the former US president Jimmy Carter cured melanoma with immunotherapy, cancer immunotherapy has become an important pillar in the management of cancer disease nowadays. Among the many drugs introduced, MSD’s (Merck in the US) ‘Keytruda (pembrolizumab)’ has risen to become the symbol of ‘cancer immunotherapy.’ The drug, which was first approved in March 2015 as a treatment for melanoma, is currently approved for 18 indications in 14 cancer types in Korea. One thing to note is that Keytruda is yet far from reaching its turning point. ◆A neglected substance becomes an all-around anticancer drug Keytruda’s history goes all the way back to 2003. Keytruda was developed as a humanized antibody by Organon, a Dutch pharmaceutical Company. In 2007, Organon was acquired by Schering Plough, and the substance was approved for clinical trials by the FDA in December 2012. In 2014, only 3 years after trial approval, the company submitted a New Drug Application to the FDA and received approval as a treatment for melanoma in September of the same year. This was how Keytruda’s journey began. One interesting aspect to note is that MSD was not a prominent player in the field of oncology. The company, whose key areas focused on chronic disease, women’s disease, and vaccines, realized the potential of Keytruda and established a business division for the single drug. MSD’s insight and drive in making the decision to invest in a substance that was neglected by the initial developer is also one key strength of the company to note. After the initial melanoma indication, Keytruda was approved as a second-line treatment for non-small cell lung cancer in 2016, an area in fierce competition. Then, the drug became the first among cancer immunotherapies to receive approval as a first-line treatment for Stage 4 metastatic NSCLC. Afterward, by adding the combination therapy option to its treatment regiment, the drug’s indication was expanded from patients with high PD-L1 expression to all patients to position itself as the standard treatment option for all patients with metastatic NSCLC. Also, Keytruda transformed the concept of cancer treatment by becoming the first to be approved for ‘tumor agnostic' use in all cancer types based on specific genetic features regardless of the initial cancer site. In Korea, the drug was approved as a second-line treatment for 7 types of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, and more recently, as a first-line treatment for metastatic MSI-H/dMMR colorectal cancer. Keytruda ◆MSD Reaps rewards for its foresight… No.1 in sales in both Korea and the global market The company reaped rewards from its aggressive investment. Keytruda recorded No.1 in global sales in 2020, earning $14.38 billion (₩16.8 trillion as of August 18th, 2021). The same went for Korea as well. According to IQVIA, Keytruda recorded ₩155.7 billion in the domestic pharmaceutical market in 2020 to rank first among all pharmaceuticals in sales and has maintained the lead in the first half of this year. In the early years of its release, in 2016 and 2017, Keytruda sold around ₩10 billion’s worth; however, its sales hit ₩70 billion in 2018. The upsurge was driven by its reimbursement approval as second-line treatment for NSCLC in August 2017. As previously mentioned, much potential remains for Keytruda. MSD is conducting more than 1,400 global clinical trials focusing on Keytruda. Korea’s contribution is also quite significant in the area. Around 120 of the global anticancer therapy trials being led by MSD are being conducted in Korea and consist of around 88% of all trials conducted by MSD Korea. Based on the number of participating patients, Korea has ranked 1st among Asia-Pacific countries and 4th in global. ◆The remaining challenge...a rough ride to reimbursement extension However, obstacles do exist in Keytruda’s winning strides as well. Reimbursement is an issue as the insurance benefit is only approved for two indications, as second-line treatment for melanoma and lung cancer. The drug was not able to extend its scope of reimbursement since September 2017. In MSD’s discussions with the health authorities to reimburse Keytruda as second-line treatment for lung cancer, its competitor, the ‘all-comer’ drug ‘Opdivo (nivolumab),’ took away a partial win by strategically narrowing its scope of reimbursement, however, Opdivo also had not seen much progress in expanding its reimbursement ever since. The discussion for Keytruda’s reimbursement as first-line treatment in NSCLC has been ongoing for around 4 years now. It took 9 attempts for the agenda to pass the Health Insurance Review and Assessment Service’s Cancer Disease Review Committee (CDRC) meeting, however, the committee still requested further revisions to be made to the cost-sharing plan. With the burden of re-revisions in mind, MSD is waiting for the agenda to be put up for deliberation by the Drug Reimbursement Evaluation Committee. With the negotiations for contract renewal of the Risk-sharing Agreement (RSA) also overlapping, Keytruda is now at its highest inflection point since its entry into the Korean market. Due to its versatility, expanding the scope of reimbursement for Keytruda may indeed result in the creation of a budget-gobbling monster. In every field, the industry always moves faster than the system. Whether Keytruda will be able to continue making progress in the sea of unprecedented, advanced new drugs that are being introduced remains to be seen.
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- Keytruda monopolizes the domestic pharmaceutical market
- by Chon, Seung-Hyun Aug 24, 2021 06:06am
- MSD's immuno-cancer drug Keytruda has taken the lead in the domestic pharmaceutical market for the sixth consecutive period since the first quarter of last year. New drugs recently released by domestic and foreign pharmaceutical companies such as Perjeta, Prolia, and K-CAB are growing. According to IQVIA, a pharmaceutical research firm on the 23rd, Keytruda recorded the highest sales of ₩93.3 billion in the first half of last year. It is up 29.% from the same period last year. Keytruda saw its sales rise 27.0% year-on-year to ₩44.1 billion in the first quarter, and continued its growth rate of 31.0% with sales of ₩49.2 billion in the second quarter. Keytruda has topped the list for the sixth consecutive quarter since its first quarterly sales of ₩34.7 billion in the first quarter of last year. Keytruda, which was released in Korea in 2015, is an immune checkpoint inhibitor that inhibits 'PD-1' protein on the surface of immune cell T cells to treat cancer through activation of immune cells. It is showing outstanding performance in more than 30 cancer species including lung, parietal, gastric, and cervical cancer. Keytruda's quarterly sales remained around ₩3 billion shortly after its release, but sales began to rise at a rapid pace since August 2017 when insurance benefits were applied as a secondary treatment for non-small cell lung cancer. Keytruda surpassed ₩10 billion in sales in the first quarter of 2018 and ₩30 billion in sales in the second quarter of 2019. In the first quarter of last year, Lipitor, which had never missed the lead in quarterly sales since the fourth quarter of 2015, was ranked No. 1 overall. In the second quarter, Keytruda had a sales gap of more than ₩10 billion with the second-largest Lippitor (₩38.3 billion). The gap with Avastin (₩30.2 billion) is close to ₩20 billion. Sales of new drugs recently released by domestic and foreign pharmaceutical companies such as Perjeta, Prolia, and K-CAB have risen sharply. Roche's Perjeta saw its first-half sales rise 29.6% year-on-year to ₩45 billion. Perjeta is a metastatic or localized HER2-positive breast cancer patient who has never received HER2 targeted chemotherapy or chemotherapy. It is a drug used in combination with Trastuzumab or Docetaxel. Perjeta is a primary treatment for HER2-positive metastatic or intemperable breast cancer patients who have never received anti-HER2 treatment in 2017, and sales also surged as Trastuzumab and combination therapy became the standard for preoperative supplementary therapy in May 2019. Perjeta ranked seventh overall in the second quarter, with sales rising 34.7% year-on-year to ₩23.6 billion. Amgen's Prolia ranked ninth overall, with sales rising 21.6% year-on-year to ₩42.4 billion in the first half. Prolia, which was released in Korea in November 2016, is a biomedicine osteoporosis treatment that targets protein RANKL, which is essential for the formation, activation and survival of bone-destroying skeletal cells. Prolia's sales have exploded since April 2019 as insurance benefits have been recognized in primary treatment therapy. Chong Kun Dang is jointly selling Prolia with Amzen. HK inno.N's new drug K-Cap, an anti-orgel drug, was the only one among the top 10 developed drugs in Korea, with sales rising 57.4% year-on-year to ₩41.7 billion in the first half. K-CAB, which was released in March 2019, is an anti- ulcer drug of the potassium competitive gastric acid secretion inhibitor (P-CAB) family of Tegoprazan. It is a new mechanism for inhibiting gastric acid secretion by competitively combining proton pumps and potassium ions located in the final stage of acid secretion in stomach wall cells. K-CAB secured an indication of gastrointestinal reflux disease as its first indication, and added gastrointestinal ulcer treatment adaptation in July of the same year, showing more sales growth. Sanofi's anti-thrombotic drug Plavix increased sales by 21.3% year-on-year to ₩46.8 billion in the first half of the year. Patent of Plavix expired in 2007 and more than 100 generics were released. It has been more than 10 years since the patent expired and is showing rather steep growth even though it competes with more than 100 generics.
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- Tylenol sales jump 140% due to the pandemic
- by Chon, Seung-Hyun Aug 24, 2021 06:05am
- Sales of the OTC antipyretic analgesic ‘Tylenol’ have soared. With the increased demand among people receiving the COVID-19 vaccinations, Tylenol sold ₩43.6 billion in the first half of this year, which is twice more than that sold in the whole term of last year. There has been criticism that the government’s recommendation to take Tylenol in the early phases of inoculation has promoted sales of specific brands. According to the pharmaceutical research institution IQVIA on the 23rd, sales of Tylenol Tab. and Tylenol 8 hours ER Tab. had sold 139.6% more year-on-year to record ₩43.6 billion in the first half of this year. Tylenol’s sales increased 167.9% YOY to record ₩33.6 billion, and sales of Tylenol 8 hours ER Tab. increased 77.0% YOY to record ₩10 billion. Tylenol and Tylenol 8 hours ER are both antipyretic analgesics containing the single-ingredient acetaminophen. Sales of both Tylenol and Tylenol 8 hours ER had surged in Q2 this year. Tylenol’s sales in Q1 increased 25.9% YOY to ₩8.1 billion, but expanded further in Q2 to increase 318.6% YOY to record ₩25.5 billion. Tylenol 8 hours ER sold ₩2.5 billion in Q1, which was a 27.9% decrease YOY to ₩2.5 billion, but sales of the product rebound in Q2 to rise 253.5% YOY and record ₩7.5 billion. Sales have increased with those receiving COVID-19 vaccinations buying Tylenol in advance to prepare for fevers or muscle aches. Inoculations started in Korea in late February, and with the number of people receiving vaccination increasing, demand for antipyretic analgesics has also surged. Also, there has been criticism over the government’s contribution to the surge of sales. The government authorities have informed people receiving COVID-19 vaccinations that “it is good to take Tylenol when fevers or other side effects arise after vaccination.” Since then, the demand for Tylenol took a sudden leap and led to shortages in its stock. Due to the continued instability in the supply of Tylenol, the government belatedly set out to address the issue. In May, the Ministry of Food and Drug Safety had announced that around 60 single-ingredient acetaminophens products are being sold in the market, and guided citizens to purchase other products. In June, the Ministry of Food and Drug Safety, Korean Pharmacists’ association, Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korea Pharmaceuticals Distribution Association, and Tylenol’s manufacturer Johnson & Johnson had agreed to work together to stabilize the supply of acetaminophen. The Korea Pharmaceuticals Distribution Association had made emergency measures to promptly supply the acetaminophen that they received to all pharmacies nationwide. The MFDS also discussed measures with the Korea Pharmaceuticals Distribution Association and Johnson & Johnson Korea to expand the supply of Tylenol to pharmacies nationwide. However, other acetaminophen products did not enjoy such an increase in their sales. Sales of major acetaminophen agents in Korea have shown that sales of Samjin Pharm’s ‘Geborin’ fell 30.3% YOY to record ₩6.6 billion in the first half of this year. Geborin’s sales fell 6.9% YOY in Q1, then increased 8.3% YOY in Q2, and did not benefit from the increased number of COVID-19 vaccinations. Sales of Chong Kun Dang’s ‘Penzal Q’ and ‘Penzal 8 hours ER’ fell 7.2% YOY to record ₩2.2 billion in the first half of this year. In fact, acetaminophen’s position in the market had become unstable with the constant safety issues that were being raised recently. The MFDS has strengthened the safety measures for prolonged-release forms of acetaminophen-containing agents in 2018 to reduce risks from overdose such as liver damage etc. The authorities reduced the package units to less than the maximum daily dose and indicated the dosing interval (8 hours) in the product name. In 2011, the strength of each dosage unit of prescription acetaminophen products was restricted to 325mg due to the risk of liver damage and allergic reactions. In addition, an impurity concern arose last year. In July last year, the acetaminophen API manufactured and supplied by the Chinese API manufacturing company Anqiu Lu'an Pharmaceutical was found to be contaminated by 4-Chloroaniline. The Ministry of Food and Drug Safety announced that it had collected and inspected a total of 60 lot numbers from all manufactories and that the impurity in question was not detected. However, the sudden spread of the pandemic and the increase in vaccinations have brought an upsurge in sales of Tylenol. Sales of the 4 Tylenol series products including Tylenol Cold S and Women’s Tylenol have recorded ₩45.1 billion, increasing 122.2% compared to the previous year.
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- Ono Pharma Korea’s Braftovi has been approved in Korea
- by Aug 24, 2021 06:05am
- Ono Pharma Korea announced on the 23rd that it has been approved by the MFDS on the 19th by Braftovi (Encorafenib), a direct bowel cancer treatment. BRAF inhibitor Braftovi can be used as a combination therapy with Erbitux (Cetuximab) in adult patients with direct colon cancer with previous treatment experience and confirmed BRAF V600E mutation. In Korea, the positive BRAF V600E gene mutation is found in 4.7% of patients with direct bowel cancer. There were no approved drugs based on effectiveness in BRAF gene-variant bowel cancer, requiring a new treatment choice. This approval is based on the results of BEACON CRC study in patients with non-ablastic progressive or recurrent direct colon cancer showing BRAF V600E mutation after primary or secondary treatment. In the study, combined therapy of Braftovi-Cetuximab is a control group, and the overall survival period (OS) compared to Irinotecan (Iritecan)-Cetuximab based combination therapy showed statistically significant extensions (HR 0.60, p=0.0003). OS median was 8.4 months for Braftovi group and 5.4 months for control group.
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- Will the issue of GLT-2 inhibitors be resolved in 3 years?
- by Eo, Yun-Ho Aug 23, 2021 10:28pm
- Attention is focusing on whether the issue of combined benefits of DPP-4 inhibitors and SGLT-2 inhibitors will finally be solved. According to academia, the HIRA will hold a meeting of experts on September and discuss the combined benefits of oral diabetes treatment DPP-4 inhibitors and SGLT-2 inhibitors. The issue, which has been almost three years, was put on full hold in 2018 when the government planned a "public notice of improvement of the benefits standard for each drug" to strengthen convenience at the medical sites and patient guarantee, but pointed out that there was insufficient evidence of validity of drugs without separate clinical research. It was the opinion of the medical community that the government should discuss expanding the combined benefits of diabetes drugs. Each drug in the same category has different indications, causing side effects such as confusion at the prescription site and cuts in insurance benefits. The same was true when the combined benefits between DPP-4 inhibitors and TZD-related drugs expanded in 2013. However, the results are different. The medical community, which has emphasized the importance of clinical experience and expert judgment rather than permission and financial impact, is also unusual. It started in 2013 when Yoon Gun-ho, a professor at Seoul St. Mary's Hospital who actively expressed his opinion to expand the benefit of diabetes drugs, became the chairman of the Korean Diabetes Association. He conveyed to the government that health insurance can be applied by affiliates as an expert's recommendation, and in August last year, the MFDS said it would "simplify" the registration method of diabetes drugs. It said that it was to reflect permits from the U.S. and Europe and the demands of the medical community and industry, but many in the industry believed that it was a cornerstone for preparing standards for combination therapy. As a result, pharmaceutical companies submitted simplified labels for the efficacy of diabetes treatments from November of the same year, and the MFDS approved Jardiance, Forxiga, Suglat, and Steglatro sequentially in the first half of this year. Companies with such drugs immediately submitted applications for expansion of combined benefits, but so far, the agenda has not been submitted to the Subcommittee. An industry official said, "We hope that this expert discussion will solve the unfulfilled demand of clinical sites. As we have accumulated experience in prescribing SGLT-2 inhibitors in Korea, we expect positive results."
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- Accumulated exports of K-Biosimilars reach ₩9Tril
- by Chon, Seung-Hyun Aug 23, 2021 05:55am
- Cumulative exports of biosimilars developed by Celltrion and Samsung Bioepis exceeded ₩9 trillion. Growth has slowed compared to the products’ first market entry, however, the products have been marking stable growth based on their solid pipeline. ◆Celltrion Healthcare exports ₩789.5billion in H1…cumulative sales exceed ₩6 trillion According to the Financial Supervisory Service on the 19th, Celltrion Healthcare’s exports reached ₩789.5 billion, a 1.6% increase from the ₩777.2 billion in the same period last year. Although growth was not as explosive as in the previous year, the company still recorded large-scale overseas exports. Celltrion Healthcare is an affiliate of Celltrion that has Celltrion Healthcare Holdings (share 24.3%) as its largest shareholder. Celltrion Healthcare sells antibody biosimilar products that it received from Celltrion to global distributors. In other words, Celltrion Healthcare’s sales refer to the export performance of biosimilars developed by Celltrion. Celltrion Healthcare is selling 4 biosimilar products including ‘Remsima,’ ‘Truxima,’ ‘Herzuma,’ and ‘Remsima SC’ in the global market. Remsima’s original is Janssen’s ‘Remicade.’ Remsima SC is a subcutaneous injection formulating of Remsima. Truxima and Herzuma are biosimilars of ‘MabThera’ and ‘Herceptin,’ respectively. By each product, Remsima sold the most in exports, recording ₩302.1 billion in H1 this year. Adding Remsima SC(₩35.1), the Remsima brand sold ₩337.3 billion in exports in H1 this year. Remsima is the first biosimilar product that was approved in 2012. It had annually recorded the highest export sales among all Celltrion’s biosimilars but was outrun by Truxima’s record of ₩786.8 billion last year. However, this year, sales of Remsima again surpassed that of Truxima and became the No.1 product in exports. Truxima’s export sales fell 25.3% YOY from ₩365.8 billion to ₩273.3 billion in H1 this year. The company explained that Truxima’s sales in Q1, which saw a 32.6% YOY decrease to mark ₩109.7 billion, was due to a temporary adjustment in the supply schedule of its products. Herzuma’s export sales in H1 this year were ₩102.3 billion, a 25.7% YOY increase. Herzuma’s share in the European market in Q1 was 15%, a slight decrease from the 19% it held in Q1 last year. However, in the Japanese market, its share exceeded that of its originator Herceptin, to record 50%. This was more than a twofold market expansion in a single year from the 25% share it held in Q1 last year. Celltrion Healthcare, which was listed on KOSDAQ in 2017, has been recording its export performance in its business report since 2014. Since 2014, Remsima and Remsima SC have recorded the most in exports with a cumulative record of ₩3.7123 trillion. Truxima, which started making export performance in 2017, marked ₩1.9925 trillion, and Herzuma’s cumulative exports amounted to ₩575.1 billion. On whole, Celltrion Healthcare’s cumulative exports from 2014 to H1 this year marked ₩6.3 trillion. ◆Samsung Bioepis makes ₩354.2 billion in H1… cumulative sales record ₩2.0889 trillion Samsung Bioepis’s operating profit last year was ₩145 billion, an 18.1% YOY increase from the same period of the previous year. Since it recorded its first profit in 2019 with ₩122.8 billion, its profit has grown even more in a single year. Samsung Bioepis recorded ₩187.5 billion in sales in Q2, which is a 22.7% YOY increase. The company had continued on a downward roll since Q3 of last year, when it recorded its all-time high with ₩236.9 billion, however, in only 2 quarters since then, the company has recovered its performance to a level similar to its pre-COVID-19 performance. The accumulated sales of Samsung Bioepis in the 1H of this year rose 5.5% compared to the same period of last year, to record ₩354.2 billion Most of its sales were generated from overseas sales of the company’s self-developed biosimilars. Samsung Bioepis had succeeded in commercializing 5 biosimilars of biopharmaceuticals – ‘Enbrel,’ ‘Remicade,’ ‘Herceptin,’ ‘Humira,’ and ‘Avastin.’ In the global market, the company has signed marketing partnership agreements with multinational pharmaceutical companies such as Biogen and Organon to sell its products. Biogen is in charge of the local distribution and sales of the three autoimmune treatments, ‘ Benepali,’ ‘Flixabi,’ and ‘Imraldi.’ Organon (formerly known as MSD) is selling the three products in countries other than the U.S., Korea, and China, as ‘Renflexis (Remicade biosimilar), ‘Brenzys (Enbrel biosimilar),’ ‘Hadlima (Humira biosimilar).’ Organon is also in charge of selling the two anticancer drugs - the Herceptin biosimilar ‘Ontruzant’ and Avastin biosimilar ‘Avincio’ – abroad. According to performance reports by Biogen and Organon, biosimilars of Samsung Bioepis had made $573 million (approximately ₩675 billion) in H1 this year. Sales made by Biogen rose 4.3% YOY to record $407 million (approximately ₩470 billion). Sales made with biosimilars through Organon were $166 million (approximately ₩195 billion). Although the drugs sold less in comparison to its performance in the European market, its growth of 43.4% YoY has been received positively due to its growth potential. Due to the preorders that were made in Q1, sales in Q2 had decreased, then rose sharply in the second half of the year with the technology fee (milestone payments) from signing biosimilar license agreements with Chinese companies such as S Bio and C-Bridge Capital in 2019 being reflected in the revenue. This year, sales have stabilized to record ₩166.7 billion in Q1 and ₩187.5 billion in Q2. Samsung Bioepis, which was established in 2012, had shown full growth since recording ₩147.5 billion in sales in 2016. Last year, sales increased over fivefold compared to four years ago. Since its launch in 2012, Samsung Bioepis has recorded a cumulative sales of ₩ 2.8895 trillion. Most of Samsung Bioepis' sales come from overseas sales of biosimilars or technology fees. Its domestic sales contributions are small compared to exports. In other words, Celltrion and Samsung Bioepis’ combined exports of biosimilars recorded over ₩ 9 trillion in total.
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- Novartis starts reimbursement discussions for Zolgensma
- by Eo, Yun-Ho Aug 20, 2021 05:56am
- After ‘Kymriah,’ Novartis has now begun the reimbursement listing process for ‘Zolgensma.' According to industry sources, the application for the reimbursement of Novartis Korea’s Zolgensma (onasemnogene abeparvovec-xioi) that was submitted through the approval-benefit appraisal linkage system will be put on the agenda for deliberation by the Central Review Adjustment Committee in coming September. As a result, Novartis, which already has Kymriah (tisagenlecleucel) set for review by the Cancer Disease Review Committee (CDRC) on September 1st, will be working with the government to list two of its blockbuster drugs for reimbursement benefit in September. And the industry's eyes are focus on whether and how the two drugs will be listed for insurance benefits. Zolgensma is a treatment for Spinal Muscular Atrophy (SMA), like ‘Spinraza (nusinersen)’ that was approved in 2017, and is a gene therapy that contains a genetic material that functionally replaces defective genes. The Ministry of Health and Welfare had approved Zolgensma as the second advanced biopharmaceutical 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 a single-shot of Zolgensma costs 2.5 billion won in the U.S. and 1.89 billion won in Japan. Due to this high price, the reimbursement approval process for Zolgensma in Korea is also not going to be easy. However, expectations on the drug's efficacy are very high. The Phase III SPR1NT and STR1VE-EU results for Zolgensma that was recently presented had received much attention to that effect. In the SPR1NT study, all pediatric SMA patients with two SMN Type 2 gene copy (Cohort 1) that were treated pre-symptomatically 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. Zolgensma is indicated in Korea for the treatment of pediatric patients with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) who ▲ have been clinically diagnosed with SMA Type 1 or ▲ has up to 3 copies of the SMN2 gene.
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- The Supreme Court again rejected α-GPC suspension
- by Chon, Seung-Hyun Aug 19, 2021 06:02am
- The Supreme Court again rejected α-GPC suspension to negotiate the withdrawal of Choline alfoscerate. Pharmaceutical companies finally lost the withdrawal negotiations. According to an industry on the 17th, the Supreme Court's special department 2 decided to reject discontinuance of trials in negotiations on the recovery of the Choline alfoscerate system filed by 27 companies including Chong Kun Dang on the 12th. Discontinuance of trials is a system that does not accept appeals if it is judged that there is no specific reason. At the end of last year, the MOHW ordered the NHIS to sign a medical care contract for the system. It means that if the clinical trial fails, the MFDS should proceed with a recovery negotiation to return the entire amount of the health insurance prescription to the NHIS from the date of submission of the clinical plan to the date of deletion. It means that if the clinical re-evaluation of the Choline alfosculate system, which is being pursued by the MFDS, fails, pharmaceutical companies will have to return the prescription results to the NHIS from the date of submission of the clinical plan to the date of cancellation of the permit. Pharmaceutical companies filed an administrative litigation and suspension of execution against the MOHW's order to negotiate the recovery. The lawsuit was divided into 28 companies including Daewoong Bio and 28 companies including Chong Kun Dang. The suspension of execution, which was raised by the Chong Kun Dang and others, was rejected in May after the ruling was rejected in January. Chong Kun Dang and others filed for a re-appeal, but it was rejected again. Following the first and second trials, the Supreme Court ruled in July that Daewoong Bio and others rejected discontinuance of trials. The suspension of execution, which was requested by pharmaceutical companies, was finally rejected. Pharmaceutical companies have also claimed suspension of execution for re-ordering the recapture negotiations. When the MOHW ordered renegotiation in June, 26 companies, including Chong Kun Dang, and 26 companies, including Daewoong Bio, were divided into an action for nullity and suspension of execution. On the 6th of last month, Daewoong Bio's request for suspension of execution was dismissed, and on the 8th of last month, the decision was made to dismiss the suspension of execution, which was raised by Chong Kun Dang and others. Chong Kun Dang and others have filed another appeal for suspension of execution.
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- Will AML drug Xospata be reimbursed through PE exemption?
- by Eo, Yun-Ho Aug 18, 2021 05:52am
- Whether the new leukemia drug Xospata that is attempting reimbursement through the PE exemption track will be able to be listed for insurance benefit in Korea is receiving attention. According to industry sources, Astellas Korea’s acute myeloid leukemia (AML) treatment Xospata (gilteritinib), which applied for reimbursement through the PE exemption track, passed the Health Insurance Review and Assessment Service’s RSA subcommittee last June. However, after passing the subcommittee, the drug’s reimbursement was no put on as an agenda of the Pharmaceutical Benefit Assessment Committee in July or August, therefore making no progress in its discussions. Accordingly, speculation is rising that ‘applying 80% of the A7-adjusted lowest price for PE exempted drugs', which has recently emerged as a hot topic in the industry, may be the cause of the delay. Xospata is the first FLT3-targeted anticancer therapy to be approved by the Ministry of Food and Drug Safety in Korea to treat FLT3 mutation-positive (FLT3mut+) relapsed or refractory AML. The drug targets both FLT3-ITD and FLT3-TKD of the FLT3 mutations and may be self-administered orally once daily as monotherapy at home without frequent hospital visits. Also, the drug demonstrated better efficacy and safety compared to chemotherapy. Xospata has received the highest - ‘Category 1’ - recommendation in the NCCN Clinical Practice Guidelines for treating patients with relapsed or refractory (R/R) AML with an FLT3 mutation. Interest in Xospata is high as a treatment option that had never existed before. In fact, the Korea Alliance of Patients Organization had delivered their opinion requesting prompt reimbursement of new drugs including Xospata at a roundtable with the Ministry of Health and Welfare’s Division of Pharmaceutical Benefits in May. Healthcare professionals have also shown high expectations for the drug. Hee-Je Kim, Professor of Hematology at the Catholic University of Korea’s Seoul St. Mary’s Hospital said, “The approval of Xospata in Korea has resolved the specific concern of patients having to endure the condition without a proper treatment option. Of course, the cost remains a problem, however, if the drug is listed for the insurance benefit, I believe it will quickly settle as the standard of care in for its indication." Kim added, “FLT3mut+ R/R AML patients need to promptly receive adequate treatment as they have a poor prognosis and are at risk of rapid disease progression. This is why Xospata is being continuously being prescribed even without reimbursement.”
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- Hanmi & Organon maintain ₩70 billion worth contract
- by Kim, Jin-Gu Aug 18, 2021 05:52am
- Hanmi has maintained a copromotion contract with Organon, which is separated from MSD. According to the Financial Supervisory Service on the 18th, Hanmi signed a domestic copromotion contract with Organon in the second quarter. The contract is due at the end of this year. The items include hair loss treatment Propecia, prostate hypertrophy treatment Proscar, and osteoporosis treatment Fosamax. The total amount of prescriptions last year amounted to ₩67.7 billion. Propsia's prescription amount is ₩41.3 billion, Prosca's prescription amount is ₩14.3 billion, and Fosamax's prescription amount is ₩12.2 billion. Hanmi had already signed a contract with MSD to promote its products. However, the contract was changed as Oganon spun off the MSD earlier this year. In the end, Hanmi and Organon signed a new contract with the same contents. Hanmi has signed contracts with MSD and Organon for more than 10 years. The renewal of the contract is also due to the contract made in 2014. At that time, the two companies drew attention by signing a two-way contract to mutually promote products from each company, rather than a one-way contract for domestic companies to promote items from multinational companies. Hanmi has decided to jointly sell MSD's Propecia, Proscar, Fosamax, Andriol, Livial, Cosopt-S, Emend, Invanz, and Ezetrol. MSD has decided to co-promote Hanmi (such as PalPal and Tamsulosin). Earlier in 2009, MSD signed an overseas export contract with Amosartan, a hypertension combination drug of Hanmi. It was the first time a multinational pharmaceutical company sold a drug developed by a domestic company. It is currently sold in more than 50 countries under the name Cozaar XQ. Last year, MSD signed a license agreement with Hanmi to develop, manufacture, and commercialize dual agonist for non-alcoholic fatty hepatitis (NASH) treatments, which was canceled due to the return of Janssen's rights. In March this year, Hanmi's hyperlipidemia combination drug Rosuzet was released in Mexico under the name of NAXZALLA, and Organon is in charge of local marketing. Hanmi signed an export contract with MSD in 2017 to 23 countries, but the contract was recently changed following the establishment of Organon.
