- LOGIN
- MemberShip
- 2026-05-17 06:39:26
- Company
- Celltrion begins global P3T for its inhaled COVID-19 therapy
- by Ji Yong Jun Feb 07, 2022 05:57am
- Celltrion HQ Celltrion has begun global Phase III trials on its ‘inhaled antibody cocktail therapy’ that is in development to respond to major variants of the COVID-19 virus, such as the Omicron variant. According to the clinical trial registry ClinicalTrials.gov operated by the US National Institutes of Health (NIH), Celltrion newly registered a clinical trial protocol on initiating a Global Phase III trial for its ‘inhaled antibody cocktail therapy’ on the website on the 4th. The trial will assess the therapeutic efficacy of the combination of ‘CT-P63’ and ‘CT-P66’ in an inhaled form to patients that were infected with mild-to-moderate COVID-19. After enrolling patients who experienced symptom onset within 7 days of COVID-19 diagnosis, participants will be divided into two groups and be administered the ‘CT-P63’ and ‘CT-P66’ combination or placebo for 14 days to assess the combination’s clinical efficacy. The patients who were administered the CT-P63’ and ‘CT-P66’ combination will be monitored for 90 days for adverse reactions. Celltrion plans to start the trial in April and expects to complete the trial by January next year. CT-P63 is an antibody cocktail therapy developed by Celltrion to respond to the emerging COVId-19 variants. CT-P63 demonstrated strong neutralizing activity against various major variants including the alpha, beta, gamma, and delta variant, and also showed strong neutralizing activity against the Omicron variant in a pseudovirus testing that Celltrion conducted with NIH. Also, a Phase I clinical trial that was conducted in Poland in 24 healthy subjects since September last year showed that CT-P63 was safe and well-tolerated, with no significant drug-related adverse events (AEs). CT-P66 is an inhaled formulation of Regkirona that is being analyzed in a Phase I trial after completing administration. The inhaled antibody cocktail therapy is considered to be more convenient in administration compared to the existing Regkirona formulation that is administered through intravenous infusion. IV infusions like the existing formulation had to be administered at the hospital for over an hour, but an inhaled formulation can be administered by the patients at home, therefore being well utilized. Celltrion said, “After developing our COVID-19 antibody treatment Regkirona, we have been developing our ‘inhaled antibody cocktail therapy’ for over a year and a half now. We expect our treatment to become a convenient and economic treatment that can respond to various COVID-19 variants, including the Omicron variant.”
- Policy
- 1 ‘Soliris’ and 4 ‘Ultomiris’ cases seek prior approval
- by Lee, Hye-Kyung Feb 07, 2022 05:57am
- The 3 applications filed for preliminary approval of reimbursement to use ‘Ultomiris (ravulizumab)’ in new patients with paroxysmal nocturnal hemoglobinuria (PNH), and 1 application for re-deliberation were approved, and 2 cases of appeals that were filed were dismissed by Health Insurance Review and Assessment Service’s Healthcare Review and Assessment Committee. In the same disease class, no new applications were filed for newly reimbursed administration of ‘Soliris (eculizumab),’ but 1 of the new preliminary approval applications filed for reimbursement in new patients with atypical hemolytic uremic syndrome (aHUS) was approved. This January, the Healthcare Review and Assessment Committee deliberated cases for Soliris, Ultomiris, mid-to-long-term hospitalization due to external injury, etc., mid-to-long-term hospitalization for pain control, short-term hospitalization due to external injury, F-18 FDG PET for liver cancer, internal nasal splints used for endoscopic transnasal transsphenoidal hypophysectomy of pituitary tumor, ventricular assist device treatment, medical and selective insurance benefit for hemopoietic stem cell transplantation, and medical insurance benefit for immune tolerance induction therapy. Results that were disclosed on the 4th show that for Soliris, 22 PNH monitoring requests were approved, 1 new request for aHUS indication approved, 4 disapproved, 1 re-administration approved, and 4 monitoring cases approved. For Ultomiris, 3 requests to reimburse new patients with PNH were approved, 1 re-deliberation approved, and 2 appeals were dismissed. Soliris, which has an insurance cap of 5,132,364 won per vial (30ml), costs around 400 million won per year in drug expenses if 3 vials are administered bi-weekly for a year. Ultomiris was listed for reimbursement at 5,598.942 won per vial on June 7th last year, and patients must receive a maintenance dose every 8 weeks 2 weeks after receiving the initial dose. As Soliris and Ultomiris are both ultra-high-priced drugs, a preliminary approval system is conducted to determine eligibility for medical care benefits. Institutions that apply for the preliminary approval must administer the said Soliris or Ultomiris within 60 days of receiving notification of the deliberation results, and must resubmit an application if it wishes to administer the drugs after 60 days. Also, the long-term care institutions that receive the approval for Soliris or Ultomiris’s medical care benefit need to submit a monitoring report every 6 months, with those using Soliris for aHUS being required to additionally submit initial monitoring reports 2 months into treatment. Further details of the deliberation can be found on HIRA’s website (www.hira.or.kr) or business portal (biz.hira.or.kr.>comprehensive review criteria service > criteria > review criteria > Open deliberation cases).
- Company
- Hugel's Letybo has been approved in France
- by Feb 07, 2022 05:57am
- Hugel announced on the 3rd that it has obtained an item license for botulinum toxin formulation Letybo from the ANSM on the 27th of last month (local time). Earlier on the 25th, Hugel received an opinion from the HMA to approve Letybo's item license. Upon receipt of the opinion, Hugel entered a national phase to enter 11 European countries, including France, Britain, Germany, Spain, and Italy. Starting with this approval, Hugel aims to ship Letybo within the first quarter and launch it in major local markets. This is the first case of Korean botulinum toxin formulations entering Europe. Hugel plans to complete its entry into 36 European countries by next year based on its entry into 11 major countries this year. An official from Hugel said, "As major countries are expected to complete the approval process quickly starting with France, we will do our best to enhance the status of the Korean medical aesthetic industry in the local market by spreading treatment solutions for healthy beauty to European practitioners and consumers."
- Company
- Samsung BioLogics acquired ₩2.8 trillion stake in Epis
- by Ji Yong Jun Feb 07, 2022 05:57am
- View of Samsung BioLogics Plant 3 (Photo = Samsung BioLogics)Samsung Biologics will acquire all of its shares in Samsung Bioepis held by its partner Biogen. Stock purchase funds are raised through a paid-in capital increase in shareholder allocation. Samsung BioLogics announced on the 28th that it has decided to acquire all 10,341,852 shares of Samsung Bioepis held by Biogen in the U.S. for $2.3 billion (about 2.7655 trillion won). Of the $2.3 billion cost of purchasing a stake in Samsung Bioepis, the acquisition price will be paid in installments over the next two years, excluding $50 million in "earn-out" costs, which will be additionally paid if certain conditions are met after the contract is signed. The contract will take effect from the time the first payment of $1 billion is completed. Biogen invested 15% of its stake when Samsung Bioepis was established in 2012. In June 2018, Biogen chose a call option to take over 9,226,068 shares of Samsung Bioepis held by Samsung Biologics. Biogen paid $700 million to Samsung Biologics, adding 50,000 won per share and interest. As a result, Samsung Biologics and Biogen shared 50%+1 shares and 50%-1 shares of Samsung Bioepis, respectively. Samsung Biologics also decided to raise 3 trillion won in paid-in capital. The paid-in capital increase will be carried out in the form of a general public offering for forfeited shares after allocation of shareholders, and the number of issued shares is 5,009,000 shares. Samsung Biologics plans to use 1.798 trillion won of the funds flowing into the paid-in capital increase as facility funds, and the remaining 1.2024 trillion won as funds to acquire shares in Samsung Bioepis. Under the decision to purchase the stake, Samsung Biologics will secure 100% of Samsung Bioepis shares. The company predicted that the acquisition of shares will accelerate preparations for the bio business. This is because the autonomy and agility of decision-making are improved compared to the current equity structure, which can quickly promote mid- to long-term growth strategies such as the development of new pipelines, open innovation, and new drug development of Samsung Bioepis. Samsung Bio's business has secured ▲CAPA No. 1 Samsung Biologics' CDMO business, ▲Samsung Bioepis' ability to independently develop proven biosimilar products, and ▲ the possibility of entering the new drug business, laying the foundation for a leap into a "global pharmaceutical company". Samsung Bioepis is currently recognized for its competitiveness by launching a total of five biosimilar products, including three autoimmune disease treatments and two anticancer drugs, and one more is about to be released with permission, and four biosimilars are in phase 3 clinical trials. The global biosimilar market is expected to continue to grow more than 8% annually from $10 billion in 2021 to $22 billion in 2030. The antibody biosimilar market, which Epis focuses on, is expected to grow about 11% annually, leading the growth of the biosimilar market. Samsung Biologics is currently constructing its fourth plant, the world's largest biopharmaceutical plant, and MultiModal Plant, which can produce various biopharmaceuticals at one plant, is also set to begin construction by the end of this yeear. Samsung Biologics plans to complete an additional 350,000㎡ site contract for the second campus, which is larger than the site currently in use (270,000㎡), at Songdo District 11 in Incheon, by the end of this year.
- Product
- Actinum is a troublemaker?
- by Kim JiEun Feb 07, 2022 05:57am
- Actinum is out of stock due to lack of inventory. The key is to return distribution inventory after the 11th. Multivitamin Actinum, which ambitiously entered Korea, is in a position to become a headache. It is not expected to be easy to order at pharmacies for the time being. According to an official at Dongwha Pharm on the 14th, Actinum's sales ended in November. As of this day, the sales authority of Donghwa Pharmaceutical has expired. The problem is that domestic pharmaceutical companies that will take over the copyright of Actinum after Donghwa Pharmaceutical have not been decided, making it virtually unclear whether they will sell it in the future. Actinum is a domestic generic of Arinamin sold by Takeda. Immediately after its launch, aggressive marketing was conducted, such as conducting public advertisements through famous celebrities. However, it was directly hit by the boycott of Japanese pharmaceutical companies' drugs in 2019, and was pushed back by a series of competitive products. The industry believes that this situation has a direct impact on the selection of pharmaceutical companies after Dongwha Pharm. An official from Dongwha Pharm said, "I think Takeda is looking for a partner in a domestic pharmaceutical company." He said, "We also asked the headquarters to discuss inventory or settlement issues when the pharmaceutical company to be acquired is decided ahead of the end of the contract, but we are in a difficult situation as there has been little talk so far. The contract ended at the end of December, and we have agreed to sell it only until January 11th, he said. This situation has recently been reflected in front-line pharmacies. At major drug online malls, Actinum EX is currently out of stock and cannot be ordered. According to local pharmacy pharmacists, only a small amount of products can be ordered from some wholesalers. A local pharmacy pharmacist said, "Actinum is not a popular item, but we have secured inventory because there are cases where patients who have taken it before are looking for it, but it has not been easy to order recently," adding, "We have only ordered a small amount of it by asking the wholesaler." Dongwha Pharm said it is difficult to return or settle distribution inventory at the company level since the 11th when the sales contract expired. An official from Dongwha Pharm said, "It is frustrating that the copyright has not been clearly cleared up by the company," adding, "It will be difficult to settle or return inventory as it does not have its own authority on distribution inventory after January 11th. However, we plan to deal with all distribution products as much as possible in November, he said.
- Company
- Lorviqua can be prescribed at general hospitals
- by Eo, Yun-Ho Feb 04, 2022 05:57am
- Preparations have begun for the prescription of Lorviqua, a third-generation ALK that seeks to register insurance benefits. According to related industries, Lorviqua of Pfizer Korea passed DC of medical institutions such as Gangnam Severance Hospital, National Cancer Center, Chung-Ang University Hospital, and Hanyang University Hospital, as well as Samsung Medical Center and Seoul National University Hospital. It is aiming to settle down in the market quickly in case it succeeds in registering salaries. Lorviqua, which first passed the HIRA's cancer disease review committee in January 2022, is currently waiting for the introduction of the Drug Reimbursement Evaluation Committee. Since Lorviqua is a drug with strength in resistance, it is believed that it will be possible to attract prescriptions quickly if the registration is made. It remains to be seen whether Pfizer, the first developer of ALK anticancer drugs, will be able to increase its market share. It was designated as a rare drug in March last year and was approved in Korea for use in cases where Alecensa or Zykadia was previously treated with primary ALK inhibitors or Xalkori and at least one other ALK inhibitor as a monotherapy for adult ALK NSCLC patients in July. Lorviqua, a third-generation drug, can be an alternative to patients who have developed resistance since Xalkori, a first-generation drug, and Zykadia and Alecensa, a second-generation drug. If Xalkori is used in the first-line therapy, Lorviqua can be prescribed after using the second-generation drug, and if the second-generation drug is used, Lorviqua can be used in the second-line therapy. Until now, chemotherapy had to be used because there was no targeted treatment available for secondary drug resistance. Resistance mutations that appear mainly after second-generation drug treatment are G1202R, and depending on the drug, they also appear in F1174L (Zykadia), I1171T/N/S (Alecensa), and E1210K (Alunbrig). Lorviqua is effective in all known resistant mutations. Meanwhile, Lorviqua recently added a non-small cell lung cancer's first-line therapy indication in Europe. The approval was based on the results of a phase 3 CROWN study. In this study, Lorviqua demonstrated improvement efficacy in indicators such as mortality risk and ORR compared to Xalkori.
- Opinion
- [Reporter’s View] Mutual understanding is required
- by Kim, Jin-Gu Feb 04, 2022 05:57am
- The National Health Insurance Service made a pre-announcement for the amendment of the detailed guidelines of the ‘Price-Volume Agreement.’ The Price-Volume Agreement, or PVA, is a system that discounts a drug’s price by up to 10% through negotiation between the pharmaceutical company and NHIS for products whose use volume had rapidly increased. The system was implemented to save NHI finances. The current system has been in place since 2014 after the system was implemented in 2007, therefore the move for its improvement seems timely. However, the NHIS and the pharmaceutical industry have mixed opinions on how to amend the system. This clash is most prominent in the matter of deciding whether to expand or reduce the scope of eligibility of the system. The NHIS believes more pharmaceuticals should be applied the system through an amendment. In other words, the authorities plan to reduce the scope of pharmaceuticals that are exempt from PVA negotiations, therefore applying the system to a broader range of pharmaceuticals. In detail, the authorities had planned to narrow the exclusion criteria to ‘below 90% of the arithmetic mean price’ from the ‘below the arithmetic mean price of same ingredient drugs,’ Under the new criteria, products subject to PVA negotiations would increase to 69 from the 59 reviewed in the previous year. On the other hand, the industry claims that the scope of exclusion should be increased to reduce even just one more pharmaceutical subject to price cuts. Currently, products that file an annual claims amount of less than ₩1.5 billion every year are excluded from PVA negotiations. The industry claims that this limit should be raised to ₩5 billion or even ₩10 billion, The NHIS had partially accepted the industry claims and can accept increasing the ceiling to ₩2 billion from the current ₩1.5 billion. Disregarding the complex calculations in place, the clashing values of the industry and NHIS are clear. The NHIS prioritizes ‘sustainability in NHI finances,’ whereas the industry prioritizes ‘concern over reverse discrimination of homegrown new drugs.’ Neither side can be 100% right, and no side should be forcing its claim on the other. This is why the NHIS’s past actions leave some room for disappointment. The NHIS had continuously emphasized that “the industry needs to understand and sympathize” with the NHIS’s position. Although the words “understand” and “sympathy” were used, in context it is more coercion than persuasion. Under the inviolability rationale of protecting the sustainably of our national health insurance, the sacrifice of the pharmaceutical industry was dismissed as a ‘trivial’ matter. The NHIS had planned to enforce the guidelines effective as of January 1st this year. However, the authorities held back from implementing the amendment due to strong opposition from the pharmaceutical industry and said it will prepare a better The industry believes that the amendments will be disclosed soon. However, one clear thing is that neither side can unilaterally continue to force understanding and sympathy on the other’s part. It is this reporter’s hope that an improvement on which both sides can truly understand and agree on could be reached soon.
- Company
- SK Bioscience appoints former BMS lead Pa-leun Kim as VP
- by Eo, Yun-Ho Feb 04, 2022 05:57am
- VP Pa-leun Kim SK Bioscience is making continued efforts to strengthen the company’s capability by recruiting talents to make the leap forward and become a global vaccine company. According to industry sources, SK Bioscience appointed Pa-leun Kim (44), former Lead at Bristol-Myers Squibb Korea, as its Vice President of Communication and Government Affairs. The company had been stepping up efforts to develop its COVID-19 vaccine while expanding its CMO business with the appointment of CEO Jae-Yong Ahn (54) in April last year. In addition to expanding its manufacturing facilities, the company has also been recruiting new talent in various areas since last year. The company's R&D personnel alone increased by 30% last year. VP Pa-leun Kim had served in the Office of the Presidential Secretary for Public Affairs at Cheong Wa Dae for 5 years since 2008 before starting his career in the pharmaceutical industry in 2013 at GSK Korea. At GSK, Kim was in charge of the company’s general communications and government affairs, promoted Fluarix Tetra’s release in Korea, and led Consumer Healthcare CGA and Communication & Government Affairs. After moving to BMs, Kim continued to accumulate extensive experience in public affairs and government affairs serving as the lead of Government Affairs & Policy. Kim acquired a bachelor’s degree in International Politics at The University of Sheffield, and a Master of Science in Forced Migration and Development Studies at Oxford University. SK Bioscience signed a CMO contract with AstraZeneca to manufacture its COVID-19 vaccine drug substance and the finished product in July 2020. In August of the same year, the company also signed a CDMO agreement with Novavax to develop and manufacture its COVID-19 vaccine. After signing a technology transfer agreement with Novavax in February last year, the company secured the rights to manufacture and sell Novavax’s COVID-19 vaccine and is also developing its COVID-19 vaccine NBP2001 and GBP510 (with aluminum adjuvant AS03).
- Policy
- Janssen Korea has obtained permission
- by Lee, Tak-Sun Feb 04, 2022 05:56am
- Janssen Korea has been approved by the MFDS for Pharmaceutical Consignment Permission for Manufacturing Business. This can be interpreted as part of the withdrawal of the Hyangnam plant. If Janssen Korea completely withdraws its Hyangnam plant, there will be no Janssen Korea plant facilities in Korea. The MFDS approved the "Manufacturing Business" of Janssen Korea as of the 26th. Drug consignment Manufacturing Business does not have domestic production facilities, but is granted to companies that are licensed for manufacturing items through consignment manufacturers. So far, 11 companies have received it. Among the nation's history, GL Pharm Tech , Corepharmbio, Crystalgenimics, Gunkang, Woosung,iN Therapeutics received a permit, and multinational pharmaceutical companies, including Organon Korea, Abbott, AstraZeneca, Moderna Korea and Janssen Korea. Janssen Korea's acquisition of a pharmaceutical consignment manufacturing and sales business is linked to the withdrawal of its Hyangnam plant. Janssen Korea stopped operating its Hyangnam plant last year. When the acquisition process is completed in the future, the factory will be used by Whanin. Janssen Korea is organizing items following the suspension of its Hyangnam plant. There are nine Janssen's remaining manufacturing permits. Among them, three items are for export and three items are commissioned and manufactured by Handok. Domestic sales items manufactured by themselves are organized into Tylenol 80mg for children, Tylenol 160mg for children, and Tylenol suspension. In the case of children's Tylenol suspension, the MFDS has currently applied for the withdrawal of permission. The remaining 80 items approved by Janssen Korea are all imported finished products. In the case of Ultracet Semi, Ultracet ER, and Ultracet ER semi, technology transfer to Handok is being produced on consignment, so Janssen needed permission to "consignment manufacturing and sales" even if the factory was withdrawn. There are two domestic pharmaceutical production facilities for multinational pharmaceutical companies: Otsuka Pharmaceutical Korea (Hyangnam Plant) and Janssen Vaccine (Songdo Plant).
- Company
- Organon Korea's Cozaar XQ will be resupplied
- by Feb 04, 2022 05:56am
- Original product for Losartan can be reproduced and prescribed in early February. Organon's HTN treatment Cozaar XQ, which was suspended due to detection of impurities above the standard last year, will be resupplied at the end of this month. Organon (CEO Kim So-eun) announced on the 27th that it will be able to re-supply Cozaar XQ from the end of this month and prescribe it from early February. Cozaar XQ, the original product, was suspended from shipping after an impurity test conducted in November last year detected more than the standard level. No impurities were detected in the same Losartan, Cozaar and Cozaar Plus. Organon replaced Cozaar XQ with French raw materials such as Cozaar and Cozaar Plus to reproduce. Normal products will begin to be supplied at the end of this month. An official from Organon said, "The Coza family, such as Cozaar and Cozaar Plus, is an original Losartan distributed through strict quality management systems and demanding production processes by global pharmaceutical companies Organon, and Cozaar also produced Azido with undetected original Losartan." Organon added that it is making every effort to be prescribed without a hitch from February through the rapid supply and demand of Cozaar XQ. In addition, the symposium Re-launching Cozaar XQ will be held in six cities in Seoul, Suwon, Daegu, Daejeon, Busan and Gwangju from February to March. Along with the results of non-detection of impurities in the Cozaar family, Organon plans to emphasize initial therapy in patients with second stage hypertension who need to be administered with a combination to reach their treatment target blood pressure.
