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- 2026-04-13 01:42:36
- Two points to note in Kymriah’s reimbursement process
- by Eo, Yun-Ho Jan 24, 2022 05:56am
- The era where a single shot can cure one’s cancer may be imminent, but with a catch: The single-shot would cost ₩500 million. Novartis’s novel CAR-T therapy ‘Kymriah (tisagenlecleucel)’ cleared all the steps necessary for reimbursement under the Health Insurance Review and Assessment Service by receiving approval on its adequacy of reimbursement at the ‘1st Drug Reimbursement Evaluation Committee meeting’ on the 13th this month. Although another hurdle -the drug price negotiation process with the National Health Insurance Service - still remains, Kymriah’s passing of the DREC review was in itself an encouraging event. The case is also notable in terms of its speed in review and reimbursement criteria. ◆10 months after MFDS review…Result of ‘longing’ and need Kymirah’s insurance reimbursement listing process was in itself a hot issue. In its every step from reimbursement application, HIRA’s Cancer Disease Deliberation Committee review, to DREC review, the issue caught the attention of the industry, patients, and the media. The drug started its reimbursement listing process under the approval-reimbursement evaluation linkage system in March last year after receiving MFDS approval. 6 months later, the agenda was put up for deliberation by the CDDC but deferred. As soon as the results were released through the media, the Korean Alliance of Patient Organizations among others issued a statement condemning the government and the pharmaceutical company. The patient association had before criticized the delay in CDDC review of Kymriah’s reimbursement. Kymriah finally passed the CDDC review in October of the same year. This was also the first day HIRA disclosed CDDC results. And then, Kymriah passed review at the first DREC meeting held in 2022. Statements from KAPO and other associations had poured out at the news of Kymirah’s agenda being deliberated at the DREC meeting. Another drug that received good news on the same day with Kymriah was MSD’s immunotherapy drug ‘Keytruda (pembrolizumab),’ which awaited 5 years (to extend its reimbursement to first-line in non-small-cell lung cancer). For patients in dire need, even the 10 months spent waiting for Kymirah would have been too long. However, considering the average time spent on listing innovative new drugs in Korea and even taking into account the disease and number of patients that benefit from the two drugs, Kymriah’s reimbursement progressed quickly. This progress is highly likely due to a combination of the patients’ ‘desperate longing’ and execution ability. The government would have felt some burden. In addition, Novartis Korea’s efforts in presenting a fiscal-sharing plan through the persuasion of its headquarters are also expected to have played a part. ◆Pediatric B-ALL indication is excluded from being applied the performance-based restriction Also, it is notable that the reimbursement standard set by DREC for B-Acute Lymphoblastic leukemia (B-ALL) is relatively lenient among Kymriah’s 2 indications. Kymriah’s indication is for the treatment of ▲ adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy, and ▲ patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (B-ALL) that is refractory or in second or later relapse. Kymriah, which is going through the reimbursement listing process through the pharmacoeconomic evaluation exemption system, is applied the expenditure cap type of Risk Sharing Agreement (RSA) scheme. As it is an ultra-high-priced new drug, the prevailing industry assumption was that additional restrictions would be set for its reimbursement in addition to the expenditure cap. This is in line with the government’s plan to converge performance-based type and the expenditure cap type of RSA as an alternative necessary for expanding coverage of high-priced new drugs. As expected, the performance-based type was additionally applied to the DLBLC. indication. The performance-based type limits reimbursement of drug expenditures according to treatment effectiveness after administration. However, no other options were set to restrict reimbursement of Kymriah other than the expenditure cap for the B-ALL indication. Although limited to B-ALL, this could be seen as the government’s allowance of a freer administration of Kymriah in the disease. In such various aspects, Kymriah’s every step of the reimbursement progress is receiving attention Whether the effective but expensive Kymriah can push through the remaining processes and get its name on the reimbursement list remains to be seen.
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- BI-Boryung concludes copromotion deal for NOAC ‘Pradaxa’
- by Kim, Jin-Gu Jan 24, 2022 05:56am
- Boehringer Ingelheim and Boryung Pharmaceuticals have concluded its co-promotion deal for Boehringer Ingelheim’s non-vitamin K antagonist oral anticoagulant (NOAC) therapy ‘Pradaxa (dabigatran).’ Boehringer Ingelheim plans to directly sell Pradaxa starting this year. According to industry sources on the 21st, Boehringer Ingelheim and Boryung Pharmaceuticals concluded their co-promotion deal for Pradaxa at the end of last year. Rather than find a new partner company to sell its product, Boehringer Ingelheim decided to sell Pradaxa directly. An official from Boehringer Ingelheim said, “The two companies agreed to terminate the copromotion deal at the end of last year. The company will be directly selling the product starting this year.” Pradaxa is a dabigatran NOAC anticoagulant that received attention for having a better effect in preventing blood clots with fewer bleeding side effects compared to the anticoagulant warfarin. Pradaxa has started replacing warfarin in the early 2010s, increasing its influence in the prescription field. Boehringer Ingelheim received approval for the drug in Korea in 2011 and released the drug the next year. A the time of release, the company joined forces with Yuhan Corp for its sale, Boehringer Ingelheim taking charge of hospital-level institutions, and Yuhan of private clinics. Then for 4 years from 2018 to the previous year, Boehringer Ingelheim worked with Boryung Pharmaceuticals for the copromotion of Pradaxa. However, the drug’s sales performance was less impressive than its competitors in the Korean market. Compared to Daiichi Sankyo’s ‘Lixiana,’ Bayer’s ‘Xarelto,’ BMS’s ‘Eliquis’ that grossed ₩50-₩60 billion per year in outpatient prescriptions, Pradaxa made less than ₩15 billion. Also, the drug’s substance patent expired in July last year. Intro Biopharma, Aju Pharm, Jinyang Pharm, and Huons had invalidated Pradaxa’s salt and composition patent and was granted generic exclusivity.
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- The growth rate of the DPP-4i market increased slightly
- by Ji Yong Jun Jan 24, 2022 05:55am
- The domestic DPP-4i diabetes treatment market, which is formed at 600 billion won a year, slowed down last year. It recorded the lowest growth rate in the last seven years. In the DPP-4 inhibitor market, where growth has slowed, the position of domestic companies has also expanded significantly. Rx sales for foreign company products fell. ◆DPP-4 inhibitor, growth rate of 1% in 7 years According to UBIST, a pharmaceutical market research firm, on the 19th, the total market for DPP-4 inhibitors last year was 611.3 billion won, up 1.3% from a year earlier. The growth rate of the DPP-4 inhibitor market is the lowest since 2014. In the past seven years, the market for DPP-4 inhibitors has grown rapidly. It increased 21.5% from 299.5 billion won in 2014 to 363.9 billion won in 2015. Since then, it has surpassed 600 billion won for the first time, recording 437.6 billion won in 2016, 468.6 billion won in 2017, 502.3 billion won (7.1%) in 2018, 569.1 billion won (13.2%) in 2019, and 602.9 billion won (5.9%) in 2020. Since MSD's Januvia was released in 2007, it has become a trend by replacing existing diabetes drugs. Since then, nine active ingredients have been released in the DPP-4 inhibitor market and are fiercely competing. ◆LG Chem, Dong-A ST, and Handok's expansion of influence in the DPP-4i market It was confirmed that domestic companies made strides in the DPP-4i market last year. The prescription amount of all three domestic pharmaceutical companies, LG Chem, Dong-A ST, and Handok, has increased. LG Chem's three types of Zemiglo prescriptions, Zemiglo, Zemimet, and Zemiro, totaled 130.3 billion won, up 8.8% from the previous year. The market share also expanded 2.1%p from 19.2% in 2020 to 21.3% last year. Despite the slowing growth of Zemiglo , the combination drug has expanded its influence. Zemiglo's prescription amount last year was 38.9 billion won, up 2.6% from the previous year. Sales of Zemimet reached 90.8 billion won over the same period, up 11.6% from the previous year. Dong-A ST's self-developed new drug Suganon series also saw its prescription amount rise. Last year, the total amount of prescriptions, including Suganon and Sugamet, surpassed 30 billion won for the first time with 32.6 billion won. The market share was 5.3%, an increase of 1.3%p from the previous year. Suganon's outpatient prescriptions last year amounted to 13 billion won, up 23.51% from a year earlier. During the same period, Sugamet also increased 39.72% to 19.6 billion won. Handok's Tenelia series recorded 46.2 billion won in prescriptions last year. Tenelia's prescription amount was 21.4 billion won, up 83% from the previous year. During the same period, Tenelia M (Tenerigliptin + Metformin) increased by 9% to 24.8 billion won. ◆ Multinational corporation DPP-4 inhibitor, slowing prescription performance The prescription performance of items from multinational companies has fallen. Last year, the total amount of prescriptions for the MSD Januvia products was 171 billion won, down 2.9% from a year earlier. Among the Januvia products, the decrease in prescriptions for Januvia was the largest at 5.8%. Sales of Janumet fell 3.8% from the previous year to 76.2 billion won, while Janumet XR's sales rose 1.8% to 50.4 billion won. Sales of the Trajenta prodcuts also slowed down. It decreased by 1.5% from 61.6 billion won to 60.7 billion won. Trajenta Duo's sales recorded 65.5 billion won, down 2.6%. Sales of Novartis' Galvus products decreased by 0.8% from 47 billion won to 46.6 billion won, and Sales of Takeda's Nesina fell 3.7% from 32.1 billion won to 30.9 billion won. In 2020, Takeda sold its rights to Celltrion in the Asia-Pacific region of 18 Rx drugs and OTC drugs. It was found that Nesina's transfer process has not yet been completed. Sales of AstraZeneca's Onglyza and Kombiglyze also fell 1.2% from 27.6 billion won in 2020 to 27.3 billion won last year.
- Policy
- Xeloda in breast cancer patients is also reimbursed
- by Lee, Hye-Kyung Jan 24, 2022 05:55am
- The stage and target of administration of Roche Korea's breast cancer treatment Xeloda (Capecitabine) and Korean Pfizer's acute lymphocyte leukemia treatment Besponsa (Inotuzumab Ozogamicin) will be changed. With the establishment of a new chemotherapy benefit standard that has deleted the classification of anticancer drugs in the first and second groups, six new items, eight changes, and eight deletion items will be made in the case of urological cancer-related anticancer drug benefit standards The HIRA announced on the 18th that it will disclose the "Amendment of Announcement (proposal) according to drugs prescribed and administered to cancer patients" and conduct an opinion inquiry until the 24th. According to the revision to the announcement, on June 1, Xeloda, which "single therapy first or higher, formal chemotherapy" was changed to "second or higher" in consideration of permission and current benefit status, requested the re-establishment of the benefit standard. Xeloda is a drug licensed as a local progressive or metastatic breast cancer treatment without an anthracycline treatment plan as a result of the HIRA review that failed both chemotherapy and 'Anthracycline' drugs, and there were no authorized countries related to the first use of the administration phase. However, the textbook mentions the advantages as an oral drug and minimization of hair loss, and the NCCN guideline recommends [I,A] (consensus 71%) when prioritizing avoiding hair loss in the 'preferred category 2A' and ESMO guidelines regardless of order. The HIRA was judged as a necessary drug for treatment at the clinical site, and the administration stage and subjects of administration were changed to patients with primary metastasis and recurrent breast cancer. Besponsa is a drug licensed under the treatment of recurrent or refractory precursor B-cell acute lymphocytic leukemia (ALL) adult patients with 'the patient with relapse or refractory precursor B-cell acute lymphocytic leukemia should have failed at least one tyrosine kinase inhibitor (TKI). The NCCN guidelines recommend category 2A for Philadelphia chromosome-positive recurrence or refractory B-cell acute lymphocyte leukemia, and the HIRA also judged it as a necessary drug for treatment and provided induction therapy (500) for "philadelphia chromosome-positive recurrence or refractory precursor B-cell acute lymphocyte." Considering that Besponsa's permission from the MFDS states that the recommended administration period is 2 cycles for patients performing hematopoietic stem cell transplantation (HSCT), CR or CRi after remission induction therapy, and an additional 1 cycle will be paid 30/100. The HIRA reorganized the standards for "details on the application standards and methods of medical care benefits for drugs prescribed and administered to cancer patients" related to urinary cancer. Since last year, the HIRA has been setting up a new anti-cancer treatment benefit standard that deleted the classification of anticancer drugs in the first and second divisions after preparing a standard (draft) in related fields and collecting opinions from related societies. When the anti-cancer drug benefit standard was enacted in 2006, drugs subject to retrial, rare drugs, or abuse were classified as second-tier anticancer drugs and used within the scope of each drug's benefit standard, and clinicians were required to properly judge and administer them. A total of 21 items were revised, including 6 new items (6 therapy), 8 changed items (26 therapy), and 8 deleted items (22 therapy). According to the specific changes by cancer type, 1 kidney cancer, 1 change (10 therapy), 2 delete (10 therapy), 5 urinary epithelial cancer (6 therapy), 3 change (10 therapy), 4 delete (3 therapy), 4 prostate cancer change (6 therapy), and 2 delete (9 therapy) were carried out
- Policy
- Improve the reimb system to accommodate high-priced drugs
- by Lee, Hye-Kyung Jan 21, 2022 05:56am
- The government expressed its will to reform the reimbursement management system with the emergence of super-expensive new drugs. At the ‘Forum for the reimbursement management of high-priced pharmaceuticals,’ Yoon Seok Yang, Director of Ministry of Health and Welfare’s Division of Pharmaceutical Benefits, said, “Concern is what I first feel when a deputy director in charge reports that a new high-priced drug was released. This is why we have no choice but to agree at least in direction that we need to improve the reimbursement system, such as the risk-sharing system and the pharmacoeconomic evaluation exemption system to ensure access for the patients.” With Novartis Korea's ‘Kymriah inj (tisagenlecleucel)’ that passed deliberation by the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service marking the start, the imminent entry of ultra-high-priced one-shot treatments that cost 500 million to 2 billion won per shot including ‘Zolgensma (onasemnogene abeparvovec)’ are increasing government’s concerns. The government’s basic plan is to use the current systems in place, including the RSA and PE exemption system, to improve access to such ultra-high-priced new drugs. Yang said, “We are assessing what factors to prioritize when evaluating the cost-effectiveness of such drugs. In other words, a well-established post-management system would be most important in terms of policy.” Yang added, “As it would cost hundreds of millions of won per administration, the pharmaceutical companies would first need to present reasonable grounds for the use of such drugs, and from the perspective of managing reimbursement, we have no choice but to focus on post-management. HIRA and NHIS would have to establish a reimbursement management system.” Viewers show interest in the reimbursement listing of ultra-high-priced drugs and its post-managemen at the live YouTube forum on high-priced new drugs Ae-Ryun Kim, NHIS’s Deputy Minister of the Pharmaceutical Management Division, said “High-priced new drugs have been granted reimbursement using various systems, including the approval-reimbursement linkage system or RSA. In particular, the cost-effectiveness of high-priced drugs that were applied the PE exemption system is difficult to determine, and this is why the need for a post-management system has been continuously raised.” Kim added, “When establishing a post-management system, we need to consider the subjects, method and use and collection of data in its design. For example, HIRA believes that tighter management would be needed in the future for Kymirah, as the measure to refund a certain amount of the cost when patients do not see an effect as well as an expenditure cap was set for the use of the drug.” DREC Chair Jung Shin Lee. Emeritus Professor of Oncology at Asan Medical Center, said “Times have changed. In the past, it was all about the quality of the drug, but now discussions are focused on patient results, and end with its cost.” “Spinraza marked the start of this discussion, and more expensive drugs will continue to be introduced. As Phase III data isn’t sufficient, the only way for us to cover the drugs is by using post-management.” At the forum, criticism also arose regarding introducing ultra-high-priced drugs through the PE exemption system. Eun-Young Bae, Professor of Pharmacy at Gyeongsang National University, said “In terms of value assessment, rather than PE exemptions, work should be done to evaluate insufficient information, identify which parts are important, and collect relevant data. Also, reevaluations should be conducted for PE exemption drugs.” Patient groups on the other hand expressed that the approved drugs should be promptly listed rather than be managed for reimbursement, even if they are ultra-high-priced. Eun-Young Lee, Director of the International Alliance of Patients Organizations, said, “Safety measures and patient protection needs to be discussed thoroughly, and I know HIRA and NHIS are contemplating on how to manage reimbursement of such high-priced drugs. For high-priced drugs, prompt access to the drugs is of utmost importance, even more so than patient accessibility in general. If the patients do not get access to the drugs in time, it wouldn’t be effective. Promptness is most important.”
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- Avastin biosimilar "Onbevezy" can be prescribed in earnest
- by Eo, Yun-Ho Jan 21, 2022 05:56am
- Samsung Bioepis' Avastin biosimilar Onbevezy has become possible to be prescribed in earnest. According to related industries, Onbevezy, a biosimilar of the blockbuster anticancer drug Avastin, passed DC of medical institutions such as Chilgok Kyungpook National University Hospital and Hwasun Chonnam National University Hospital, including Samsung Medical Center, Seoul National University Hospital, and Asan Medical Center. It has been entering the market quickly since insurance benefits were registered in September last year. Onbevezy's price was set at 208,144 won for 0.1g/4ml and 677,471 won for 0.4g/16ml. Compared to the original Avastin, it is 69% and 63%, respectively. Boryung Pharmaceutical, which has signed a domestic exclusive copyright agreement between Onbevezy 100mg and Onbevezy 400mg since May last year, is expected to actively carry out promotions. Avastin is a targeted anticancer drug with various indications. According to IQVIA, a pharmaceutical market research firm, Avastin's domestic sales reached 118.1 billion won in 2020. It is also a product that recorded sales of 7.73 billion Swiss franc (about 8.8 trillion won, as of 2019) in the global market. Competition for Avastin biosimilars is expected to expand further. In May last year, Pfizer's 'Jairabeve was approved in Korea, and Alvogen Korea's product was also approved on the 19th. Celltrion's biosimilar is also in the process of licensing in September last year. If it expands its scope to markets around the world, more companies are competing. Mvasi, co-developed by Amgen and Allergan, is already competing with Avastin. In addition, Beringer Ingelheim, Biocon, AstraZeneca, Kyowa Kirin Korea, Celltrion, and Prestige BioPharma are developing biosimilars.
- Policy
- Alvogen targets the Korean market with a Spanish biosimilar
- by Lee, Tak-Sun Jan 21, 2022 05:56am
- Alvogen’s Korea is attempting to target the domestic anticancer drug market with a Spanish biosimilar. Its product is the third Avastin (bevacizumab) biosimilar to enter the market after Samsung Bioepis and Pfizer. On whether the new biosimilar will become a new sensation among latecomers in the market and is gaining attention. On the 19th, the Ministry of Food and Drug Safety approved Alvogen Korea’s ‘Arimsis inj.’ a monoclonal antibody treatment for cancer that contains the same ingredient as Roche Korea’s ‘Avastin inj.’ A clinical trial on 625 healthy male adults or patients with advanced or metastatic non-squamous non-small-cell lung cancer was conducted to assess the drug’s equivalence in pharmacodynamics and efficacy to its comparator. The drug's pharmacodynamic equivalence was demonstrated in 114 healthy male adult participants who received 'Arimsis' and its comparator Avastin. Also, the efficacy of the drug was verified through a study on 511 patients with advanced or metastatic non-squamous non-small-cell lung cancer. Results showed that the objective response rate (ORR) of the patients was statistically equivalent to that of its comparator. Until now, only a few biotech companies attempted to develop biosimilars due to the large-scale facilities required. Through active investment in such facilities, the Korean companies Celltrion and Samsung Bioepis have been dominating the global biosimilar market. However, global pharmaceutical companies have also recently joined in the competition. Amgen&Allergan and Pfizer received US FDA's approval for their Avastin biosimilars. Also, Samsung Bioepis and Celltrion are attempting to receive FDA approval for their Avastin biosimilars. In Korea, Samsung Bioepis’ ‘Onbevzi,’ and Pfizer’s ‘Zirabev’ received approval one after another and are soon to compete in the domestic market. Alvogen’s biosimilar ‘Arimsis’ was developed by a less well-known Spanish pharmaceutical company, mAbxience Research. mAbxience is a biotech company that specializes in the development of biosimilars. The company, which was established in 2020, had been developing biosimilars of Mabthera (rituximab) and Avastin (bevacizumab). Its Avastin biosimilar was first approved in Latin America in 2016, then approved by the European Commission last year. The company has applied for the drug’s approval to the US FDA in June last year. Alvogen succeeded in becoming the third Avastin biosimilar to be approved in Korea using mAbxience’s product that had already been approved overseas. In particular, this product has the same indication as Avastin. Avastin and Arimsis are indicated for ▲metastatic colorectal cancer ▲metastatic breast cancer ▲non-small cell lung cancer ▲ advanced or metastatic renal cell carcinoma ▲glioblastoma ▲epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, and ▲cervical cancer. On the other hand, the indication for Samsung Bioepis’s ‘Onbevzi inj.’ excludes second-line treatment of epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer to evade Avastin’s use patent. Alvogen first filed a trial to invalidate the use patent of Avastin in August. Samsung Bioepis also joined in the patent challenge after Alvogen filed the claims.
- Policy
- Pt management is required to provide high priced 1 shot tx
- by Lee, Hye-Kyung Jan 21, 2022 05:56am
- Starting with Kymriah of Novartis Korea, which recently passed the HIRA Drug Reimbursement Evaluation Committee, the search for management measures for ultra-high-priced one-shot treatments has begun with Zolgensma, which is expected to enter Korea. In the end, the government's plan to manage the benefits of expensive drugs is a contract that uses treatments as DLBCL, but turns the benefits for patients who do not work into sharing by pharmaceutical companies. Kymriah, which passed the Drug Reimbursement Evaluation Committee on the 13th, was also recognized for his eligibility, but conditions for applying DLBCL and Expenditure Cap have been attached, and all expensive drugs are likely to follow the contract in the future. Byun Ji-hye, a deputy researcher at HIRA, announced domestic benefit plans such as expensive drugs using actual clinical grounds at the "Expensive Drug Benefit Management Forum" held on the 19th, saying, "We need to think about how to manage patients who have administered but are ineffective. I think pharmaceutical companies should also bear the list." In the case of the SMA treatment Spinraza (Nusinersen), which is managed by the pre-approval system, Spinraza has been administered for two years, but there are several cases where the exercise function evaluation score continues to be "0". She said, "In Korea, there are no specific standards for maintaining and improving exercise functions." She said, "We believe that performance-based benefit management is necessary by setting the minimum score for improving exercise function, which is clinically meaningful, and considering clinical improvement scores." Spinraza is an ultra-high-priced new drug with an insurance cap of 92.35 million won per bottle of 5ml, and nursing institutions that want to take it must apply for pre-approval and submit monitoring reports every four months after approval of benefit. When drug price negotiations with the NHIS are completed soon, Kymriah, which is scheduled to be registered, and Zolgensma, which is expected to enter Korea, will have to use the pre-approval system like Spinraza. The HIRA's high-drug benefit management plan also suggested approval and monitoring of patients subject to administration using the pre-approval system, financial management using risk-sharing systems (RSA), benefit standards based on revaluation results, and domestic clinical guidelines. Deputy researcher Byun said, "Expensive drugs should be administered to optimal target patients for efficient use of limited resources. Monitoring and re-evaluation should be conducted through patient-level data collection by establishing a disease-level registry." It also came up with financial management plans such as refunding patients' events during the monitoring period of pharmaceutical companies, adjusting the refund ratio reflecting the evaluation results after the end of the contract period, and setting the total amount considering the financial impact. Deputy researcher Byun emphasized, "benefit standards and domestic clinical guidelines are also needed, such as collecting essential clinical information for screening and evaluation and analyzing it with related clinical societies when re-evaluating in connection with health care big data such as billing data."
- Company
- CKD Bio & Cutia Therapeutics signed a supply contract
- by Chon, Seung-Hyun Jan 21, 2022 05:55am
- CKD Bio is targeting overseas markets for botulinum toxin drugs under development. CKD Bio announced on the 19th that it has signed a supply contract with Cutia Therapeutics for Tyemvers, a botulinum toxin. The size of the contract is 8.3 billion won, which supplies the product to China, Hong Kong, Macau, and Taiwan for 15 years after licensing Chinese products. The step-by-step milestone is a condition that receives $2.5 million when applying for a clinical trial plan in China and $1 million and $1.5 million when approving product licenses in Korea and China, respectively. Tyemvers is the product name of a botulinum toxin drug under development by CKD Bio. This contract is the first overseas expansion signed by CKD Bio since it started developing botulinum toxin drugs. In June 2019, CKD Bio signed a contract with a European-based research institute to introduce a license for commercialization of botulinum strains and prepared to enter the botulinum toxin market. The completion ceremony of the CKD Bio Osong plant held at Osong Life Science Complex in December last year. (From the right), Korea Bio Chairman Ko Han-seung, KPBMA Chairman Won Hee-mok, Cheongju City Vice Mayor Lim Taek-soo, CKD Bio CEO Lee Jung-jin, CEO of Chong Kun Dang Holdings Kim Tae-young, Director of Economic and Trade Bureau Shin Hyung-geun, and CEO of Bell E&C Lee Hwan-young CKD Bio completed the construction of the Osong plant, a production facility exclusively for botulinum toxin, at Osong Life Science Complex in Cheongju, North Chungcheong Province, in December last year. CKD Bio Osong Plant is a production plant dedicated to botulinum toxin drugs at the level of cGMP in the United States. It was completed two years after the construction began in June 2019. It was built with a total floor area of 13,716㎡ on 21,501㎡ of land with an investment of about 45.7 billion won. It has an annual production capacity of 6 million vials of botulinum toxin and plans to expand its production to 16 million vials in the future. CKD Bio went through a full-time trial of botulinum toxin and received approval from the MFDS on the 18th and entered the full-fledged development stage. In a clinical trial conducted at Chung-Ang University Hospital, the safety and effectiveness of CKDB-501A are compared with Botox in adults who need to improve middle or severe wrinkles. CKD Bio said, "CKDB-501A does not use animal-derived ingredients, so higher safety can be expected. Through phase 1 clinical trials, we can expect the economic effects of the country through import substitution and export in the botulinum toxin market, which aims to improve wrinkles between our eyes."
- Company
- 60 billion won worth of neutropenia market fluctuates
- by Kim, Jin-Gu Jan 20, 2022 05:55am
- The market for neutropenia treatments worth 60 billion won a year is expected to fluctuate significantly. The copyright of the No. 1 and No. 2 items in the second-generation neutropenia treatment market has shifted in succession, and new drugs have joined the competition in six years, signaling a upheaval. ◆Boryung and Jeil will change the top 2 items in the market and announce competition According to the pharmaceutical industry on the 20th, Boryung Pharmaceutical recently signed a co-promotion contract for Neulasta (Pegfilgrastim) with Kyowa Kirin Korea. Boryung Pharmaceutical will start selling Neurastar in earnest starting this year. GC Pharma's Neulapeg (Pegteograstim)' contract, which had been jointly sold until last year, ended. With the end of the business with Boryung, Jeil will jointly sell it with GC Pharma from this year. Neutrophilia refers to an abnormally low neutrophil level in the blood. If neutrophils decrease, they become vulnerable to bacterial and viral infections. Cancer patients' neutrophil levels decrease during chemotherapy, and neutrophil reduction drugs prevent this. The first-generation treatment was administered four to six times per cycle of chemotherapy. The second-generation treatment can be effective only with one administration per cycle. Neulasta and Neulapeg are the No. 1 & No. 2 items in the second-generation neutropenia treatment market. According to IQVIA, a pharmaceutical market research firm, Neulasta posted sales of 18.9 billion won and Neulapeg posted sales of 16.5 billion won until the third quarter of last year. Sales in 2020 are 25.1 billion won for Neulasta and 15 billion won for Neulapeg. Interestingly, Boryung and Jeil's reversed position. Jeil, Neulapeg's new partner, has co-sold Neulasta from 2014 to 2017. Boryung Pharmaceutical co-sold Neulapeg from October 2018 to last year. In other words, Jeil Pharmaceutical, which used to sell Neulapeg in the past, and Boryung, which sold Neulapeg, took charge of Neulasta. ◆ Neulasta with new engine vs Neulapeg with replaced power The key is whether Neulapeg's growth will continue. Neulapeg was somewhat sluggish until Boryung joined. In 2018, the fourth year of its launch, sales were only 4 billion won. It more than doubled to 8.9 billion won in 2019 when Boryung joined in earnest. In 2020, it rose 69 percent again to 15 billion won.Last year, Neulapeg almost caught up with Neulasta. Quarterly sales of Neulasta and Neulapeg differed by about five times from 6.2 billion won to 1.3 billion won in the first quarter of 2019, but narrowed the gap to 6.5 billion won to 6.3 billion won in the third quarter of 2021. In this situation, Boryㅕng Pharmaceutical's contract, which was evaluated as the biggest driving force behind Neulapeg's rise, was terminated. Jeil, which took over Neulapeg from Boryung, was burdened with maintaining the existing upward trend. Boryung, which has market-leading products, is also inevitable to establish a new strategy. If a sales and marketing strategy has been established from the perspective of a chaser until last year, a new strategy should be established to shake off such pursuit from this year. ◆ Rolontis, the first new drug in 6 years Another variable is Hanmi Pharmaceutical's Rolontis(Eflapegrastim). Hanmi Pharmaceutical received domestic approval for its own new drug Rolontis in March last year. It is the first new drug in six years as a treatment for neutropenia. Rolontis is a long-term persistent drug that is applied with Hanmi Pharmaceutical's own platform technology "Labscovery (once a month)." It is administered once per anticancer cycle. It was on the health insurance benefit list in November last year. Hanmi Pharmaceutical plans to start selling Rolontis in earnest starting this year. Although it is a newly released drug, the patient's economic burden is the lowest. The insurance price of Rolontis is 489,796 won. It is the lowest price among the second-generation neutropenia treatments. Neulasta's price is 785,525 won, Neulapeg 576,230 won, Dulastin 586,643 won, and Lonquex 594,429 won. It remains to be seen whether Dulastin and Lonquex, which were pushed back by Neulasta and Neulapeg, will rebound. Dong-AST's Dulastin, licensed in 2014, generated 2.7 billion won in sales in 2020. Teva-Handok's Lonquex, licensed in 2015, recorded 3.3 billion won in sales in the same year. Accumulated sales in the third quarter of last year were 2.4 billion won in Dulastin and 2.3 billion won in Lonquex.
