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- 2026-04-10 23:45:50
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- GC Pharma exclusively distributes and sells Baraclude
- by Kim, Jin-Gu Jan 13, 2023 06:01am
- GC Pharma announced on the 11th that it will extend the contract to sell Baraclude, a hepatitis B treatment by BMS Korea, and expand its partnership to exclusive distribution and sales. The two companies have continued their partnership related to Baraclude since September 2015. Through this contract, GC Pharma strengthened its influence through exclusive distribution and sales in the form of Co-promotion. In addition, the sales area will be expanded from the hospital and clinic level to all hospitals, including general hospitals. Baraclude is a hepatitis B treatment. With its strong virus inhibition effect and low resistance expression rate, it has topped the list of prescriptions for years since its launch in Korea in 2007.
- Company
- Baxter's core business unit spun off
- by jung, sae-im Jan 12, 2023 04:32am
- Baxter will spin off its key business unit. The industry expects the division to become independent and sell it to private equity funds. In the aftermath, the Korean branch is reducing its workforce. According to the pharmaceutical industry on the 12th, Baxter Korea recently conducted voluntary retirement (ERP) for its employees. Those who have worked for more than 10 years or were born in 1977 are eligible. The compensation condition is known as '2n+2'. This means that retirement benefits will be paid twice the number of years of service plus two months. The reduction of Baxter Korea's workforce is related to the global headquarters' decision to spin off its business units. Recently, Baxter announced that it will spin off its core business unit. The plan is to spin off 'Renal Care and Acute Therapies Global Business Units (GBUs)' and list it newly. The Xinjiang division accounts for about half of Baxter's total sales. It also includes peritoneal dialysis machines, which have the highest sales, and hemodialysis products, which are major products. The independent corporation also includes a portfolio of new products to be released in the future. The industry expects Baxter to spin off its key department into an independent corporation and then go through the sale process. It is predicted that the amount sold will be used to pay off the debt of the acquisition fund. In 2021, Baxter acquired Hilom, a digital medical device company, for $10.5 billion (about 12 trillion won) in cash. 분사되는 신장 사업부(좌)와 기존 박스터 매출(자료: 박스터) Baxter has a precedent of selling its hemophilia treatment division in 2015. The division, which includes items related to hemophilia treatments such as "Adbate," was established as an independent corporation called "Box Alta" and sold to Shire for about 32 billion dollars (about 38 trillion won) the following year. It was the largest M&A transaction in the pharmaceutical industry at the time. As the Xinjiang division is also making solid sales as a key division of Baxter, it is predicted that a "big deal" will occur. However, the decision to spin off is expected to lead to confusion in the Korean branch. An industry official said, "Baxter has built a solid position by operating the Xinjiang division for more than 60 years. However, he/she seems to have decided to spin off because he/she believes that there is not much room to expand the market, such as losing market share to competitors recently, he/she said. "The company is in a chaotic atmosphere due to issues such as manpower reduction, spin-off, and sale."
- Company
- Celltrion launches Stella PO development with U.S. Rani
- by Jan 12, 2023 04:30am
- Celltrion Research Institute is conducting research and development on pharmaceuticals.Celltrion announced on the 9th that it has signed a contract with Rani Theraputics, a bio company in San Jose, USA, to develop Stella PO. Celltrion exclusively supplies Rani Theraputics with the Stella biosimilar CT-P43, which is needed for Stella PO (RT-111) non-clinical and phase 1 clinical trials. In the future, it will have priority negotiation rights on global development and sales rights. Rani Theraputics has developed a platform technology that can use intravenous and subcutaneous injection-type protein and antibody drugs for oral use through its own oral capsule platform RaniPill capsule. Oral capsules made with RaniPill technology break down capsules in the small intestine. The drug is delivered to the small intestine through a soluble microneedle in the capsule and then transferred to the blood vessels. Although it is an oral drug, it is a platform technology designed to deliver drugs similar to injections through microneedles mounted on capsules. CT-P43's original drug, interleukin (IL)-12, 23 inhibitor Stella, is intended for two types of intravenous and subcutaneous injections. It is used for indications such as flake psoriasis, Crohn's disease, ulcerative colitis, and psoriatic arthritis. According to Johnson & Johnson's management performance, Stella is a blockbuster biopharmaceutical that recorded 9.134 billion dollars in sales in 2021. Starting with oral Stella development collaboration, Celltrion plans to expand collaboration in applying innovative drug delivery platforms not only through CT-P43 but also throughout its product pipeline. Through this, it is expected that the products currently being developed will also have differentiated competitiveness.
- Company
- 80 companies participated in the K-Cab patent dispute
- by Kim, Jin-Gu Jan 12, 2023 04:30am
- The patent dispute over HK Innoen's gastroesophageal reflux disease treatment K-Cab has expanded to the largest scale ever. A total of 80 companies challenged HK inno.N. According to the pharmaceutical industry on the 10th, a total of 80 companies have challenged K-Cab crystalline patents by the 9th. On December 24 last year, SCD filed a passive judgment on the scope of rights in the K-Cab crystalline patent for the first time. By the 9th, 80 companies challenged the same patent. These 80 companies qualified for the "first trial request," one of the generic for exclusivity requirements, by filing the same trial within 14 days of the SCD's filing of the trial. It is the largest ever based on a single item. Previously, there were large-scale patent challenges in the pharmaceutical industry, but there were 40 to 50 participating companies. However, Chong Kun-dang and Daewoong Pharmaceutical, which were active in challenging pharmaceutical bio patents, did not enter the dispute. This is because Chong Kun Dang jointly sells HK inno.N and K-Cab. Analysts say that Daewoong Pharmaceutical is selling Fexuclu, a competitive drug of K-Cab. During this period, 247 documents were filed with the Patent Tribunal. The figure adds to all the cases in which a generic company filed a judgment for the purpose of more than two claims. K-Cab is protected by a total of two patents. It is a substance patent that expires in August 2031, and a crystalline patent that expires in March 2036. Among them, the patents requested by generic companies are crystalline patents. If generic companies succeed in avoiding crystalline patents, they will be eligible to release late-stage drugs after the expiration of the substance patent in 2031. Although there is a long time left until the expiration of material patents, the reason why generic companies are interested in patent challenges is that K-Cab is performing very high in the prescription market. According to UBIST, a pharmaceutical market research firm, K-Cab surpassed 100 billion won in prescriptions in 2021, the third year of its launch. Last year, it booked a total of 92.2 billion won in the third quarter, surpassing 100 billion won for the second consecutive year. K-Cab is the flagship product of HK inno.N. It is a P-CAB-based gastroesophageal reflux disease treatment, and continues to grow with advantages such as that it is more effective than existing PPI-based products and can be taken regardless of before and after meals.
- Policy
- Sama Pharm’s formoterol to receive clinical reevaluations
- by Lee, Hye-Kyung Jan 12, 2023 04:29am
- After the authorities issued a notice on conducting clinical reevaluations for the active ingredient formoterol fumarate, Sama Pharm, the only company that maintained its authorization for the ingredient, was found to have submitted a clinical trial protocol for its acute bronchitis indication among its 3 approved indications (bronchial asthma, acute bronchitis, asthmatic bronchitis). The Ministry of Food and Drug Safety ordered clinical reevaluations to be conducted for 16 tablet and syrup products that contain formoterol fumarate on December 23, 2020 and requested companies to submit their clinical trial protocols by March 31, 2021. However, all companies that own items other than the 3 items that were the first to receive marketing authorization in 1986 – Sama Pharm’s Atock Tab. Sama, and Sama Atock Tab. 20μg – have voluntarily withdrawn their licenses after the notice. According to the minutes of the advisory meeting of the Central Pharmaceutical Affairs Council that was recently disclosed by the MFDS, the CPAC approved the adequacy of Sama Pharm’s clinical trial protocol (its scope of effect·efficacy, trial period) but requested the company to submit data that adequately describes the basis for calculating the number of trial subjects. The minutes also showed that Sama Pharm first submitted clinical trial protocols for bronchial asthma and acute/chronic bronchitis but received administrative disposition for non-submission of supplementary materials, and then resubmitted a clinical trial protocol only for its acute bronchitis indication. Also, the company set the efficacy endpoint for the reevaluation as the 'improvement of wheezing,’ and the MFDS determined the endpoint reasonable in consideration of the pharmacological action of the active ingredient, the age of the test subjects, and expert advice from the Korean Academy of Tuberculosis and Respiratory Diseases. However, to address concerns about bias due to subjective judgment on the improvement of wheezing in the evaluation index, the CPAC ordered trial objectivity to be secured through a clinical trial design (placebo-controlled, double-blind). Regarding the validity of the scope of efficacy and effect verification in the clinical trial, one committee member pointed out, "As the trial will only prove efficacy and effectiveness in pediatric patients with acute bronchitis, its actual scope of use in the field will be different” Another member said, “The drug has been long used in the field, therefore, the drug is expected to be used for indications other than acute bronchitis even though the clinical trial is conducted only for acute bronchitis.” Meanwhile, the MFDS had recommended against the use of long-acting beta-agonists (LABAs) such as formoterol as monotherapy in asthma patients based on the US FDA’s analysis. The FDA had also issued such a guideline based on a study that showed that using LABA alone may increase the risk of exacerbation of severe asthma symptoms.
- Company
- Dupixent to be reviewed by DREC for reimb after 2 years
- by Eo, Yun-Ho Jan 12, 2023 04:29am
- The atopic dermatitis treatment ‘Dupixent’ has taken a step forward in extending reimbursement to children and adolescents. According to industry sources, the low-dose formulation (200mg) of Sanofi-Aventis Korea’s Dupixent (dupilumab) will be deliberated by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee today on the 12th. This progress has been made 2 years after the company applied for the reimbursement extension in April 2021. It first took 7 months for expert opinion inquiries to begin on extending reimbursement of Dupixent to pediatric and adolescent patients, and the reimbursement standards for the indication were set in May last year. Being a high-priced new drug, the drug, which had difficulty being approved for reimbursement the first time, is having difficulty extending reimbursement as well. Although the specific indications may differ, the difference in speed of progress is evident when compared to other JAK inhibitors that applied for reimbursement extensions in atopic dermatitis, such as Lilly Korea’s ‘Olumiant (baricitinib),’ Abbvie Korea’s ‘RInvoq (upadacitinib)’ etc. The price of JAK inhibitors is also relatively lower than that of Dupixent, and the two drugs were both listed for reimbursement in May last year. Therefore, whether Dupixent will be able to pass DREC review and be extended reimbursement remains the focus of attention. However, the remaining journey will not be so easy for Dupixent. Being an RSA (Risk Sharing Agreement) drug as well as the addition of the separate 200mg dose, the drug will have to pass HIRA’s cost-effectiveness review process and complete drug pricing negotiations with the National Health Insurance Service. Meanwhile, the 300mg dose of Dupxient is currently reimbursed for adult patients aged 18 years or older with chronic severe atopic dermatitis who have had the condition for over 3 years and satisfy all three of the following criteria: ▲ who are unable to control their symptoms after receiving topical treatment for over 4 weeks, and ▲ unable to use systemic immunotherapies due to side effects or saw no response (50% or more decrease in EASI, EASI 50) after receiving treatment with systemic immunotherapies, and ▲ had an EASI score of 23 or higher before administering Dupixent.
- Policy
- Take the burden off the hospital bills
- by Lee, Tak-Sun Jan 12, 2023 04:29am
- The NHIS announced that it had expanded the scope of particular calculation for rare diseases and chronic kidney dialysis patients subject to particular calculation of health insurance from January 1 this year to ease the burden on the medically vulnerable. The expansion will significantly reduce the burden on patients by lowering the burden on them from 20% of hospitalization and 30% to 60% of outpatients to 10% of both hospitalization and outpatients. First of all, it is expected that about 4,000 people with the disease will benefit from medical expenses reduction as special calculation cases will be applied to 42 new rare diseases, including "polycystic kidney, common chromosome dominance." The NHIS has been working with the Korea Centers for Disease Control and Prevention, which manages rare diseases, to collect opinions from patient groups and experts, and has been reviewed and resolved by the Ministry of Health and Welfare and the Corporation. With this expansion, the number of rare diseases subject to the particular calculation will increase to 1,165. Accordingly, patients with new rare diseases will pay 10% of their own charges for treatment of diseases registered for particular calculation and complications with clear medical causality with the disease, and health insurance subscribers with a median income of less than 120% (less than 130% for children) can receive 10% of their own charges through the Korea Centers for Disease Control and Prevention. In addition, special cases for calculating patients with chronic renal failure apply to outpatient treatment on the day of dialysis and inpatient treatment related to the procedure. Previously, failure to receive dialysis on the same day due to unavoidable reasons such as blood vessel surgery or bleeding after hemodialysis may cause excessive dialysis or financial burden. Based on expert advice and medical evidence, the system has been improved to allow dialysis vascular procedures and surgery. The improvement of the system is expected to further benefit artificial kidney dialysis patients, who have not been subject to special cases due to failure to perform dialysis after vascular procedures and surgery for dialysis. Lee Sang-il, senior executive director of the corporation, said, "The NHIS will continue to work with related agencies such as the Ministry of Health and Welfare and the Korea Centers for Disease Control and Prevention to strengthen essential medical coverage for the vulnerable by continuing to find and calculate rare and severe incurable diseases that require long-term treatment."
- Policy
- Erbitux deal is in renegotiation
- by Lee, Tak-Sun Jan 12, 2023 04:29am
- MerckThe third Risk Sharing Agreement (RSA) contract for Erbitux, a treatment for metastatic direct bowel cancer and cranial cell cancer, is being prolonged. It is known that renegotiations have been underway since the first round of negotiations with the National Health Insurance Service broke down. Erbitux's second RSA contract period has ended as of June last year. According to the corporation and the industry on the 7th, Merck and the NHIS are negotiating for a third contract as Erbitux's renewal of RSA has ended. Erbitux signed its first RSA for Refund contract in 2014. And after four years of the contract, he succeeded in renewing his contract in 2018. It was the first case of renewal as an RSA drug. The renewal period ended in June last year, and negotiations have been underway for a third contract. The first round of negotiations broke down in August of that year, and it was found that renegotiations were currently underway after going through the HIRA Drug Benefit Evaluation Committee again. The renegotiation period is 60 days. As negotiations are currently underway, the effectiveness of the existing RSA contract is maintained. However, in the worst case, if the renewal fails, the burden on patients is expected to increase. Erbitux is currently supplied at an upper limit of 222,325 won per bottle. When a refund contract is signed, the pharmaceutical company will refund a certain percentage of the insurance claim to the NHIS. However, the refund rate is not known. Erbitux recorded sales of 42.4 billion won as of IQVIA 2021. Meanwhile, as of July 2022, a total of 60 RSA contracts were counted. Among them, 18 items were maintained to renew their contracts, 24 items were initially maintained, and 18 items were expired. RSA was introduced in 2014.
- Company
- The effect of government regulation
- by Chon, Seung-Hyun Jan 11, 2023 05:59am
- More than 7,000 Rx drugs have withdrawn from the market over the past 3 years, the report showed. It is analyzed that this is due to the fact that the item license renewal system, which regularly checks the safety and efficacy of drugs, has been established and a series of market withdrawals due to continuous clinical re-evaluation. Some point out that the government's pressure to re-evaluate generic drug prices also encouraged the market to withdraw. According to the Ministry of Food and Drug Safety on the 11th, a total of 2,167 cases were withdrawn from the market last year, including the withdrawal and cancellation of Rx drugs. The number of Rx drugs permits was 93.8% higher than 1118. This means that there were about twice as many professional drugs in which market withdrawals entered the market as new markets last year. The number of withdrawals and cancellations of Rx drug licenses surged 68.1% from 1,600 in 2019 to 2,690 in 2020. In 2021, 2,595 Rx drugs were withdrawn, and more than 2,000 Rx drugs disappeared for the third consecutive year until last year. A total of 7452 Rx drugs have been withdrawn from the market over the past three years due to the withdrawal and cancellation of permits. A total of 3,796 Rx drugs returned permits over the three years from 2017 to 2019, with the number of products withdrawn from the market doubling over the next 3 years. It is analyzed that the number of products disappearing from the market has increased due to the combination of government regulatory movements such as drug item license renewal, clinical re-evaluation, and price of generic re-evaluation. It is pointed out that the withdrawal of expired drugs from the market has increased due to the establishment of the item license renewal system. The key to the drug item renewal system, which was based on the revision of the Pharmaceutical Affairs Act in 2012, is that drugs approved by health authorities must be re-certified every five years to maintain their licenses. Existing drugs on the market have been verified for safety and efficiency once every 16-20 years through a procedure called reevaluation. However, the renewal system was introduced because it was deemed necessary to operate a reasonable evaluation system according to rapid scientific development. Drugs licensed from January 1, 2013 are maintained only after submitting data related to safety and efficacy every five years and being judged suitable by the Ministry of Food and Drug Safety. If a drug whose item license expires does not submit data for renewal, the license will be canceled. An industry official explained, "After the implementation of the item license renewal system, even if there are no safety and efficiency problems, the practice of withdrawing products with low sales volume from the market has been established." The government's continuous revaluation policy is also cited as a factor that accelerates the product cleanup phenomenon. In the case of clinical re-evaluation, which rechecks efficacy and safety, it often leads to the withdrawal of the drug from the market. For example, in the case of Choline alfoscerate, a brain function improvement drug, more than half of the licensed products left with the start of clinical re-evaluation. In June 2020, the Ministry of Food and Drug Safety requested the submission of clinical trial data for Choline, and 57 pharmaceutical companies were approved for re-evaluation clinical plans. Initially, the Ministry of Food and Drug Safety ordered a total of 134 companies to re-evaluate Choline's clinical trials, but less than half of 57 companies were approved for re-evaluation clinical trial plans. This means that 77 companies gave up the re-evaluation of Choline and chose to withdraw from the market. Recently, some diagnose that the withdrawal from the Rx drug market has increased due to the re-evaluation of generic drug prices. In June 2020, the Ministry of Health and Welfare announced a plan to reevaluate the upper limit of drugs that maintain the previous drug price if Generic, which does not meet the highest price requirements, submits BA test and registered raw material drug data by February 2023. The re-evaluation of the generic drug price is a policy to apply the new drug price system, which took effect in July 2020, to the original generic. Each time one requirement is not met, the upper limit is lowered by 15%. Pharmaceutical companies should choose strategies to accept drug price cuts for consignment generics or avoid drug price cuts through additional investments. Requirements for the use of registered raw materials can be met through the replacement of raw materials and medicines. Pharmaceutical companies are in a situation where they have to choose between accepting drug price cuts or maintaining drug prices through conducting BA tests. Accordingly, pharmaceutical companies are actively conducting BA tests on licensed generics. The goal is to avoid lowering drug prices through permission to change the drug price by making generics through pharmaceutical research, conducting BA tests, and obtaining equivalent results. At this time, if the permission is changed while converting consignment manufacturing to its own manufacturing, the company is using a strategy that meets the requirements for 'BA test implementation'. For pharmaceutical companies, if additional investment is burdensome, they have no choice but to accept a reduction in drug prices. It is known that many generics often choose to withdraw from the market rather than accept drug price cuts. Some analysts say that reckless entry into generics, which did not take into account marketability before the government tightened regulations on generics, may have led to a withdrawal from the market after stricter regulations. In 2018, 175 items containing Valsartan, a hypertension treatment, were banned from selling due to the detection of excess impurities. At that time, the Ministry of Health and Welfare and the Ministry of Food and Drug Safety set up a "consultative body for improving the generic drug system" and began to come up with measures to curb the generics crisis. As the government hinted at the government's move to tighten regulations, pharmaceutical companies moved to install generic products in advance, temporarily increasing generic permits. The number of Rx permits reached 1,562 in 2018, which surged to 4,195 and 2,616 in 2019 and 2020, respectively. 374 of the Rx licensed in 2019 returned their permits. In other words, it withdrew from the market less than three years after it was approved by the government's move to tighten regulations. There are also more products that disappear from the market due to unexpected variables such as impurities. The Ministry of Food and Drug Safety decided in September 2019 to ban the sale of all products containing Ranitidine, citing excessive detection of NDMA, a carcinogenic substance.
- Policy
- NHI coverage rate 64.5% in 2021...Fell 0.8% YOY
- by Lee, Tak-Sun Jan 11, 2023 05:59am
- The National Health Insurance Service announced that Korea’s health insurance coverage rate in 2021 had fallen slightly from the previous year to 64.5%. On the 10th, the NHIS announced so through the ‘NHI Patient Medical Expense Survey 2021’ report on the 10th In 2021, the NHI coverage rate decreased by 0.8%p YoY to record 64.5%, and the non-reimbursement burden rate increased by 0.4%p YoY to record 15.6%. The NHI coverage rate is calculated by dividing the insurer’s reimbursement expenses by the sum of the insurer’s reimbursement expenses, legal copayment amount, and non-reimbursed medical expenses. The total coverage rate in medical institutions has decreased due to decreased coverage rates in clinics despite the increased coverage in general or higher-level hospitals. The expanded scope of reimbursement for ultrasounds [chest (amended in April 2021), heart (Sep 2021)] and the reduced use of advanced hospital wards (single-bed ward) led to a 0.5%p increase in the coverage rate in general or higher-level hospitals to 69.1%. The coverage rate in clinic-level institutions fell 4.1%p due to the increase in the proportion of non-reimbursed medical services (+4.8%p) such as manual therapy (rehabilitation and physical therapy expense), and multifocal intraocular lenses for cataract surgery (treatment material). However, the coverage rate for severe and high-cost medical treatments has increased continuously. The coverage rate for the 4 major diseases was 84.0%(+0.1%p), and the coverage rate of the Top 30 severe and high-cost diseases (leukemia, pancreatic cancer, lymphoma, etc.) was 82.6% (+0.5%p), and Top 50 diseases (Top 30+dementia, pulmonary tuberculosis, etc.) was 80.3% (+0.2%p). The coverage rate of those that belong to the age group - ‘5 years or younger (71.0%),’ and ’65 years or older (70.3%)’ - was higher than other age groups. However, in the case of those in the ’65 years or older' group, their coverage rate in tertiary hospitals, general hospitals, and hospitals has increased, but their coverage rate in clinic-level institutions has fallen by 0.9%p from the previous year due to their increased use of manual therapy and multifocal intraocular lenses for cataract surgery, etc. By income level, the NHI coverage rate (including the effect of the copayment ceiling system) of those in the lower-income bracket was higher than that of those in the higher-income quintile group (as classified by quintile of health insurance premiums), and the effect of the copayment ceiling system was found to be greater in the lower-income quintile group.
