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Company
Pharmaceutical industry starts face-to-face marketing
by
Kim, Jin-Gu
Apr 18, 2022 05:58am
As the government decided to completely lift social distancing measures from today (18th), the pharmaceutical bio industry is also actively planning offline marketing events. As large-scale offline events have been virtually impossible for nearly two years, marketers are raising expectations for changes caused by the move. ◆ Abolish social distancing in 2 years On the 15th, Prime Minister Kim Boo-kyum announced that social distancing will be lifted from the 18th through a meeting of the COVID-19 Central Countermeasure Headquarters held at the Seoul Government Complex. After today, the limit on the number of private gatherings and restaurant business hours will be removed. It is the first time in two years and one month that the social distancing guidelines are completely lifted. The pharmaceutical bio industry welcomes this measure. This is because offline marketing events have been virtually impossible due to restrictions on the number of private gatherings. There are also notable places that are preparing for a large-scale event next month. Boryung is planning a symposium on the launch of 'Dukarb Plus' next month. Dukarb Plus is the seventh product of Boryung's Canarb Family. An official from Boryung said, "We are preparing for a launching symposium at a hotel in Seoul next month," adding, " we are planning various offline symposiums and seminars for each business headquarters." The offline Dukarb Plus launch symposium contrasts with the online launch symposium when Dukaro and Akarb were released two years ago. Boryung held the Dukarb launch symposium online for the first time in the industry in March 2020. This web symposium was a great success with 2,500 medical staff accessing at the same time. In September, Akarb was released and similarly opened a web symposium. ◆ Pharmaceutical industry is planning to hold offline events in earnest in the second half of the year Other companies have similar situations. Although the timing of the resumption of offline symposiums, seminars, and product briefings are different, expectations are high that more active offline events will be possible by lifting social distancing measures. A marketing manager at a large pharmaceutical company said, "Since the beginning of this year, social distancing measures have been loosened little by little, and small product briefings have been sporadic," adding, "If the distance disappears, offline events will be more active." Another official from a large pharmaceutical company said, "We have focused on online marketing so far," and predicted, "Marketing activities such as symposiums, seminars, and product presentations will be carried out in a way that combines online and offline." Small and medium-sized pharmaceutical companies are even more pleased with the move. A marketing manager at a small and medium-sized pharmaceutical company said, "In the case of large pharmaceutical companies, they created their own online platform and carried out marketing activities, but small and medium-sized pharmaceutical companies failed to do so," adding, "We plan to actively carry out offline marketing events from the end of this month." ◆The workshop that has been postponed for two years is also moving to resume, "following the company's guidelines Internal events such as workshops and company dinners are also being resumed. However, it is confirmed that it is approaching somewhat more carefully than offline marketing events. An official from the pharmaceutical industry said, "Most of the workshops over the past two years have been replaced online or canceled altogether." Although no official company-level guidelines have been issued yet, offline workshops and dinners are expected to resume soon, he explained. An official from a multinational pharmaceutical company said, "It was like that before, but we will carry out offline activities according to the company's guidelines," adding, "Until now, offline events, whether internal or external events, have been completely banned. In the future, it is expected that it will be changed in a way that combines online and offline." Another multinational pharmaceutical company official said, "There is no immediate change," and predicted, "However, as distancing has been lifted from the second half, restrictions are expected to disappear in the stage of preliminary review or preparation."
Company
DHP Korea faces reimb. reevaluations for its HA eye drops
by
Nho, Byung Chul
Apr 18, 2022 05:58am
How DHP Korea, a company specializing in eye drops, will be establishing a strategy to defend its sales ahead of the upcoming reimbursement reevaluations for its HA (hyaluronic acid) products next year is drawing attention. In particular, this upcoming risk is highly likely to serve as a testbed to verify the company’s newly appointed CEO Eunyoung Park’s ability in crisis management and the creation of new growth engines. Eunyoung Park, who was formerly the SSK business unit head of Zuellig Pharma, was appointed head of DHP Korea last month. One key point of concern is whether the Health Insurance Reimbursement and Assessment Service’s reimbursement reevaluations would result in partial reimbursement cuts or large-scale reimbursement deletions, depending on which the company’s loss in sales would vary significantly. DHP Korea made sales of ₩57.3 billion in 2021, among which ₩34.1 billion was from reimbursed eye drop products. The other ₩23.1 billion was from CMOs and other deals. The external growth of HA eye drops accounted for ₩25.1 billion, 43% of the company’s total sales and 73% of the company’s sales from eye drops. This concentration on HA eye drops is why the reimbursement reevaluation of sodium hyaluronate eye drops by HIRA that is scheduled next year is foreshadowing a huge blow to DHP Korea's performance, regardless of whether it results in reimbursement cuts or deletions. DHP Korea’s key product, HA eye drops, had recorded its peak sales in 2020 at ₩30.4 billion, then fell to ₩5 billion last year. Other than Tearin F (₩1.2 billion→₩2.4 billion), Tearin S (₩2.8 billion→₩2.2billion), Tearin Free (₩14.3 billion→₩8.8 billion), and Tearin P (₩11.9 billion→₩11.5 billion) all showed negative growth. DHP Korea said, “Nothing has been determined yet on whether the reimbursement evaluations on sodium hyaluronate eye drops will be deleted or reduced. We will seek a strategic breakthrough after examining how it goes."
Policy
Reimb. suspension on rebate drugs unconstitutional
by
Lee, Tak-Sun
Apr 18, 2022 05:58am
박성민 변호사 A claim that applying the reimbursement suspension system on illegal rebate drugs that had been abolished in 2018 to acts that had been made before the law was revised can be unconstitutional has been raised. Due to unreasonable aspects of applying the existing law, the claim is that it is more reasonable to retroactively apply the law revised in 2018. Lawyer Seong-min Park at HnL law firm explained so at the monthly academic conference of The Korean Society of Law and Medicine that was held on April 16th. At the virtual conference, Park reviewed the ‘unconstitutionality of the insurance reimbursement suspension disposition applied under the National Health Insurance Act,’ and announced that the decision to suspend reimbursement for rebates caught before September 2018 violates the principle of prohibition of penalty surcharges or the principle of equality presented under the Constitution. The reimbursement suspension dispositions on drugs caught with illegal rebates had been first made in May 2017 after the system was introduced in 2014. However, due to concerns over hindered patient accessibility and side effects that arise from substituting drugs for non-medical reasons, the government revised the law to impose price cut dispositions rather than reimbursement suspensions in 2018. However, the government has applied the old law and issued reimbursement dispositions to acts of rebates that arose before September 2018, raising controversy. Park said, “The National Health Insurance Act revised as of 2018 does not stipulate which law to apply for rebates made before September 2018, however, the administrative agency has been issuing reimbursement suspension dispositions.” He added, “The retroactive application of the law, in particular, retrospective application of administrative laws is generally against the rule of law and therefore is not accepted as it unfairly infringes upon individual rights and freedoms and threatens the stability of living by the law. However, retrospective application of laws and ordinances is permitted as an exception in cases where there is no direct relationship to the interests of the general public or when the interest is rather advanced or eliminates disadvantages or suffering.” This is in accordance with the Supreme Court precedent that was made in May 2005 (Ruling No: 2004다 8630). He said, “We can’t definitively conclude that reimbursement suspensions are more advantageous than drug price cuts for the pharmaceutical companies. If the company clearly states it prefers price cuts over reimbursement suspensions, the protection of trust on the company’s part is rendered unnecessary, and the retroactive application of price cuts is therefore allowed as it can advance the interests of patients, doctors, pharmacists, health insurance finances, and pharmaceutical companies." In other words, the retroactive application of the revised law is reasonable even for rebates that occurred before September 2018. If the upper limit of fines is applied under the old law, the company may request a 40% penalty for one year of its sales rather than a suspension of reimbursement, and the authorities may exercise discretion. Park added that even if the law that was revised last year is applied, the company may request to receive a large fine that is applied for third violations under the current law rather than a reimbursement suspension, on which the authorities can also exercise discretion. Park said, “By substituting reimbursement suspensions to fines for lowest-priced drugs, the company may be subject to monetary sanctions through fines. Also, the price of drugs that are not lowest-priced can be effectively reduced by inducing voluntary drug price cuts, which can effectively result as same as drug price cut dispositions.”
Policy
Utilizing RWD for Re-evaluation of Old Drugs
by
Lee, Hye-Kyung
Apr 18, 2022 05:58am
Discussions were conducted at the Central Pharmacist Review Committee on the criteria for clinical re-evaluation of items licensed on the basis of foreign drug formulas without efficacy evaluation. The drug was Hanall Biopharma's "Blistop (p-Aminomethyl Benzoic Acid)" and was approved on May 16, 2001, and its efficacy expired on April 1. At the time of approval, Blistop was awarded to the eight major foreign drug formularies, allowing item approval without clinical data. However, with the recent revision of the permit regulations, it is impossible to permit drug formalities alone, and efficacy evaluation standard of "old drugs" used in the field for decades without efficacy evaluation has become controversial. According to the minutes of the committee's "Advice on the adequacy of drug item renewal" held by the MFDS on the 29th of last month, it was very difficult to prove its effectiveness through clinical re-evaluation. The MFDS said, "The items licensed based on foreign formularies have already been used in clinical sites for decades, and what to do with efficiency evaluation is a problem in the renewal of Old Drugs." "In consideration of not only clinical re-evaluation but also the use of RWD, we will only recognize the efficacy that can prove its validity through protocol review and approval procedures," he explained. Currently, the company has submitted opinions on clinical re-evaluation, and the MFDS is considering various methods such as clinical trials as well as post-marketing clinical trials. In this regard, a member said, "In the situation where there are differences in permission for each drug used for hemostasis, Blistop is well used so far in clinical sites," adding, "Since there is no significant adverse reaction, it is reasonable to give opportunities according to the company's will." Another member suggested, "It is difficult to objectively judge the validity of all drugs approved in the past. The MFDS needs to ease regulations on Old Drugs and prioritize safety evaluation over efficacy." It is unreasonable to impose restrictions on drugs that have been used for a long time since there is no safety problem, and the effectiveness is evaluated in the market, and drugs that are not effective will be eliminated in clinical practice. However, the MFDS agrees that the need and use in the market can naturally induce eviction, but there is a limit to maintaining permission as it is effective in the absence of clinical data as foreign formularies, the basis for licensed drugs, disappear. At the meeting that day, it was decided to renew the p-Aminomethyl Benzoic Acid item on the premise of validation.
Product
Gov discusses presenting regulatory sandboxes for ER OTC
by
Jung, Heung-Jun
Apr 18, 2022 05:57am
The Ministry of Trade, Industry and Energy conducted an opinion survey of government departments on regulatory sandbox agendas related to safety medicines (medications that are urgently used for mild symptoms among general drugs and can be used by patients themselves). If discussions on special regulations on safety medicines begin following teleconference vending machine, repercussions are expected in the pharmacist society. The Ministry of Trade, Industry and Energy's Regulatory Sandbox team conducted an opinion inquiry last month with the Ministry of Health and Welfare, which is in charge. If the final agenda is confirmed as a result of the opinion inquiry, the discussion is expected to take place through the Special Regulatory Review Committee. An official from the Ministry of Trade, Industry and Energy said on the 14th, "We conducted an opinion inquiry at the end of March regarding safety and emergency medicine. We have not yet been able to confirm the details of the case. The Ministry of Health and Welfare also said, "It is true that discussions on the introduction of regulatory sandboxes on the issue of deregulation of safety leapfrogs have begun," and that nothing has been decided yet. The convenience store industry has continuously demanded the expansion of safety medicine items. Discussions have not progressed so far, but they are sticking their heads out through regulatory sandboxes again. Currently, the issues required by the industry are considered to be ▲ Expansion of safety medicine items ▲ Release of 24-hour operating conditions ▲ Delivery of safety medicine services. Although it is conditional on 24-hour operation to handle safety emergency medicine, there have been calls in the industry to remove restrictions as more convenience stores have shortened operating hours due to COVID-19. In response, the pharmaceutical association has insisted that convenience stores that are not operating 24 hours a day should be stopped. There is also a demand to allow safety medicine delivery services. Kinetet, which includes Naver, Kakao, Nexon, Netflix, and Woowa Brothers Corp, also delivered the plan to the presidential transition committee of Yoon Seok-yeol. According to a government official, it is highly likely that it will be an agenda for review of special regulatory cases if opinions are inquired by the ministries in charge Meanwhile, in February, the Ministry of Trade, Industry and Energy deliberated and resolved 14 agendas, including non-face-to-face medical counseling services for overseas Koreans.
Policy
Will losses from drug price cut dispositions be recovered?
by
Lee, Jeong-Hwan
Apr 15, 2022 06:03am
The Ministry of Health and Welfare and the pharmaceutical companies are intensely arguing over the application of an indemnification system where the pharmaceutical company’s damages are refunded by the government if they win the administrative suits for price cuts and reimbursement suspensions. As the system has already met the administrative notice period and completed the Regulation Reform Committee procedures, all that is left is for the MOHW to decide upon its implementation and period, but the pharmaceutical companies have been raising issues and requesting the government to amend the specifics in the bill. On the 14th, the MOHW had announced it had started an internal review process for the partial revision of the “Criteria for Decision or Adjustment on Drugs.” The administrative pre-announcement of the amendment that was presented on January 17th contained guarantees that refunds losses incurred by drug manufacturers, etc. as results of administrative trials and litigations. In essence, the government will recover the damages incurred if the pharmaceutical company wins after filing an administrative lawsuit against the MOHW’s disposition such as drug price cuts, reimbursement suspensions, or deletions. The pharmaceutical industry has been protesting that the system does not fully reflect reality. The companies are stressing that, unlike the price cut dispositions where the price can be immediately restored if the company wins the suit, damages from dispositions such as reimbursement suspensions or reductions cannot be recovered even afterward. For example, just a 1 month's suspension of reimbursement would result in the deletion of the prescription code at healthcare institutions, due to which the drug would lose its foothold in the market. Reducing the scope of reimbursement would also render considerable losses in prescriptions as the doctors would switch to other drugs, but the refunded amount is too insufficient to cover the losses. The companies believe that if they win the suits after reimbursement suspension or reduction dispositions, the government should compensate for its damages until the company fully recovers the damages caused by the disposition. In addition, the pharmaceutical companies insisted that an appropriate rate should be set through calculation by the Loss Estimation Committee rather than the MOHW unilaterally calculating the refund rate for drugs subject to reimbursement application suspensions or reductions. Whether the government would accept the industry’s argument will affect the final implementation of the system. If the MOHW accepts a broad range of opinions made by the industry, it may be necessary for the authorities to take additional administrative notice procedures. The MOHW is currently preparing the final administrative notice for review by the Ministry of Government Legislation after completing the Regulation Reform Committee procedures as well as opinion collection from the industry. An official from MOHW said, “We are internally discussing whether to accept the opinion collected during the administrative pre-announcement period. It has not been decided whether we will be reflecting the changes, and after we make a decision, we will receive a review from the Ministry of Government Legislation."
Company
Dividend payout for Pfizer is 12.48 million won
by
Chon, Seung-Hyun
Apr 15, 2022 06:03am
Pfizer Pharmaceutical Korea performed better last year with sales of the COVID-19 vaccine, but its dividend was only 12.48 million won. Regardless of the sharp rise in performance, the dividend payout ratio was only 0.01%, allocating 20% of the capital of preferred stocks. It has adhered to a unique dividend policy that distributes 12.48 million won in total except for twice in the past 20 years. According to the Financial Supervisory Service on the 14th, Pfizer Korea decided to pay 12.48 million won in dividends last year. Dividends have been set at 12.48 million won for the fourth consecutive year since 2018. Although its performance improved significantly with the COVID-19 vaccine last year, dividends were calculated on the same scale as before. Pfizer Korea's sales soared more than four times from 391.9 billion won in 2020 to 1.694 trillion won last year. The amount is more than twice as much as 751.6 billion won recorded in 2017 before Pfizer Korea spun off with Viatris. Pfizer's performance soared as it supplied the COVID-19 vaccine developed with Germany's BioNTech. Pfizer Korea recorded an operating loss of 7.2 billion won in 2020, with its operating profit rising to 59.2 billion won last year. Net profit reached 95.9 billion won last year. The sale of land and buildings at its headquarters in Jung-gu, Seoul, generated 44.4 billion won in profits from disposal of tangible assets, further expanding its net profit. Dividends paid to shareholders are proportional if a company's net profit surges, but it is interesting that last year's dividend of Pfizer Korea was set at 12.48 million won, the same as the previous year. The dividend payout ratio stood at only 0.01 %. Pfizer Korea calculated dividends by applying a dividend rate of 20% to preferred stock capital. Pfizer Korea has a total capital of 922.92 million won. Among them, common stock capital is 860.52 million won and preferred stock capital is 62.4 million won. Dividends of 12.48 million won were set at 20% of 62.4 million won in preferred stock capital. The largest shareholder of Pfizer Korea is Pfizer's Dutch subsidiary 'PFG South Korea 1 B.V.' with a 97.15% stake. Pfizer Korea issued a total of 12.8 million preferred shares. Among them, PFOFG South Korea 1 B.V. holds 7,280 shares, while domestic shareholders hold the remaining 5,200 shares. PFOFG South Korea 1 B.V. and domestic shareholders receive 7.28 million won and 5 million won in dividends from Pfizer, respectively. As of the end of November 2020, the capital of Pfizer Korea was 12.08 billion won. However, the capital was reduced to 922.92 million won as the extraordinary shareholders' meeting at the end of 2020 decided to incinerate 2,233,416 shares for a fee of 61,000 won per share owned by ordinary shareholders. Preferred stocks did not change, so the same dividend as the previous year was set according to the dividend calculation standard of "20% preferred stocks." For 20 years since 2002, Korea Pfizer has been paid 12.48 million won in dividends on the same basis of 20% of preferred stocks except for No. 2. In 2017, dividends were set at 79.794 billion won, more than net profit. At that time, both common stocks (2,455,520 shares) and preferred stocks (12,480 shares) decided to pay 660% of the par value of 5,000 won as a dividend rate, expanding the amount of dividends. In 2008, a dividend of 190 billion won was set. Even though it recorded a deficit of 600 million won at the time, high dividends were confirmed as it decided a dividend rate of 3045% compared to its face value. In the past 20 years, only two high dividends have been set, and the rest have continued to have a small dividend policy of 12.48 million won. In other words, the headquarters made profits by making high dividends once a decade on average. An official from Pfizer Korea said, "We cannot disclose the background of the dividend decision." Pfizer
Company
Acromegaly drug ‘Somavert’ lands in ‘Big 5’ hospitals
by
Eo, Yun-Ho
Apr 15, 2022 06:03am
The new acromegaly drug ‘Somavert’ may now be prescribed at general hospitals in Korea. According to industry sources, Pfizer Korea’s Somavert (pegvisomant) has passed the review of Drug Committees at the ‘Big 5’ tertiary hospitals in Korea including the Samsung Medical Center, Seoul National University Hospital, Seoul St.Mary’s Hospital, Asan Medical Center and Shinchon Severance Hospital. The drug can now be prescribed at most major hospitals in Korea. As Somavert has been listed for insurance benefit in September last year, no barriers remain in patients' access to the drug. Acromegaly, which is also known as giantism, is a rare condition characterized by the excessive secretion of growth hormones that causes abnormal, excessive secretion of IGF-I, and is most often caused by a benign tumor of the pituitary gland. Acromegaly is associated with clinical changes including reduced life expectancy, cardiovascular issues, enlargement of hands, feet, and other organs, facial deformity, fatigue, joint pain, metabolic disorder, etc. In such cases, the mortality rate is twice or even three times higher than normal people. Also, as the physical deformities do not return to normal, early diagnosis and treatment are very important. Somavert’s efficacy was demonstrated in the randomized, double-blind, pivotal SEN-3614 study that was conducted on 112 patients with acromegaly for 12 weeks. The 112 patients were randomly assigned to receive 10mg, 15mg, and 20mg of pegvisomant or placebo every day, and its primary efficacy endpoint was the percent change in serum IGF-I concentration from baseline to Week 12. Study results showed that in Week 12, the median serum IGF-I concentration reduction level was 16.8%, 26.7±27.9%, 50.1±26.7%, 62.5±21.3% for the placebo arm, and 10mg, 15mg, 20mg pegvisomant arm, respectively. In other words, Pegvisomant significantly reduced serum IGF-I concentrations in all three doses compared to placebo. The rate of patients whose serum IGF-I concentrations normalized compared to baseline were 10%, 54%, 81%, and 89% for the placebo arm and 10mg, 15mg, and 20mg pegvisomant arm, respectively. Pegvisomant showed a significantly higher rate in all three doses compared to placebo. Meanwhile, Somavert was approved for the treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF-I concentrations or was not tolerated in September last year and designated an orphan drug in 2018.
Opinion
[Reporter's eyes] Despite Tessentrick's high sales
by
Apr 15, 2022 06:03am
According to Roche audit report, the company recorded sales of 343.9 billion won and operating losses of 69.6 billion won last year. Sales fell 22.5% year-on-year, and operating losses increased. This is the first drop in sales in 10 years for Roche Korea, which has increased its sales every year. It is the largest deficit in 10 years. Roche Korea has blockbuster products like anti-cancer drugs. Based on IQVIA, a pharmaceutical research institute, two of the top 10 best-selling drugs in Korea last year were Roche products. Avastin recorded 112.3 billion won in sales and Perjeta 93.9 billion won in sales. Sales of Tecentriq, an immuno-cancer drug, also amounted to 67.2 billion won, and Herceptin's sales amounted to 65.3 billion won. Roche Korea has a risk-sharing contract with the NHIS for Kadcyla, Perjeta, Herceptin, and Tecentriq. It is a contract in which the company refunds the amount of medication equivalent to the excess amount to the corporation during the agreed period. Each year, the company calculates the estimated amount of the risk-sharing refund as unpaid expenses and deducts it from sales. Last year, the estimated risk-sharing refund set by Roche Korea was1942 billion won and the amount paid was 77.2 billion won. An additional 200 billion won in refunds was incurred alone. The remaining amount of refunds at the end of the year reached 178.5 billion won, including 61.6 billion won, the basic amount. In terms of figures alone, they have to pay more than half of Korea's total sales. The refund amount of Roche was not large from the beginning. It was enough to cover 9.4 billion won at the end of 2017, 31.7 billion won at the end of 2018, 49.9 billion won at the end of 2019, and 61.6 billion won at the end of 2020. Then, the amount of refunds increased sharply last year, increasing the company's burden. How the pharmaceutical company set the ratio of refunds with the government is private. However, the industry views Tecentriq's influence highly. The government accepted the government's proposal to share Tecentriq, generic for immuno-cancer drugs, to quickly enter the market, which may have made it difficult for Roche. At the time of Tecentriq's registration, Roche Korea was the only company with immuno-cancer drugs to accept the government's proposal to "burden pharmaceutical companies for the initial three-cycle medication cost." It also accepted the proposal of an "initial treatment refund type" that refunds the administration for an initial period of time depending on whether or not the patient responds to the expansion of the benefit. Therefore, there was also a story about Tecentriq that "the more you sell, the more you lose." Thanks to this, Tecentriq was able to quickly increase its market influence, but the company cannot be amused by the rapidly increasing amount of refunds. Since Roche does not make drugs by itself, but buys and sells finished products from its headquarters, the amount of refunds accumulated in hundreds of billions of won is a loss. Fortunately, Roche Korea's financial condition is very good. As of last year, cash and cashable assets amounted to 82.9 billion won, and retained earnings amounted to 135 billion won. In other words, the refund is still "at a level to cover." However, if the refund occurs nearly 200 billion won every year, financial stability is likely to falter. Last year, 1942 billion won was generated, and the debt ratio increased sharply. The debt-to-equity ratio of the company, which stood at 89% in 2020, stood at 203% at the end of last year. Roche Korea is trying to revise the refund conditions in the RSA renewal negotiations. However, due to the nature of immuno-cancer drugs, it is not easy to change the conditions already accepted once in favor of pharmaceutical companies at a time when there are many indications to negotiate the expansion of benefits. This is why Roche's concerns are deepening.
Company
Artiva expands contract to develop dell therapy with MSD
by
Eo, Yun-Ho
Apr 15, 2022 06:03am
GC Pharma affiliate Artiva Biotheraputics announced on the 12th that it has signed a contract with MSD to expand the development of natural killing (NK) cell therapy. Artiva was established in 2019 by GC CELL and GC LABTECH in San Diego, USA. Under the contract, the two companies will promote joint research on anticancer drugs that combine NK cell therapy AB-101 under development with Tri-Specific NK-Cell Engagers owned by MSD. In particular, this contract was signed by Artiva in January last year after exporting platform technology worth KRW 2 trillion to MSD with GCELL. Artiva is already jointly developing three "CAR-NK cell treatments" for MSD and solid cancer treatment. The triple-specific NK cell-binding antibody of MSD used in this combination therapy is combined with cancer cells and specific antigens expressed in NK cells, and then activates NK cells to directly kill cancer cells, as well as activates other immune cells around cancer cells to remove cancer. Artiva's AB-101 is one of the NK cell pipelines derived from homeostatic cord blood based on GC cell technology. Artiva was approved by the FDA in December 2020 and is conducting phase 1 and 2 clinical trials for patients with recurrent and intractable B-cell lymphoma in the United States. Peter Flynn, Artiva co-founder said, "We have built a fantastic partnership with MSD over the past year. We are pleased to extend our partnership to include the development of our homologous NK cell therapy-based triple antibody candidate material."
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