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- 2025-12-27 05:14:55
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- Labor union protests against Lundbeck Korea for 50 days
- by An, Kyung-Jin Jun 10, 2020 06:09am
- Labor union picketing in front of Lundbeck Korea office on June 8 The conflict is deepening between Lunbeck Korea and employees regarding a recent layoff. On June 8, the Lunbeck Korea Chapter of Korea Democratic Pharmaceutical Union protested in front of the company’s head office in Songpa-gu, Seoul. Denouncing the unfair labor practice by the company management, the labor union has been picketing outside the building during commuting and lunch time for 50 days. And 10 of the Korea Democratic Pharmaceutical Union associates were present at the site as well. Lundbeck Korea Labor Union is a negotiating body established in July last year. The labor union joined the umbrella union as a new chapter, because the employees felt insecure in their job when the company unilaterally changed the regulation on employees in between job assignments. Lundbeck Korea Labor Unions’ long fight started from two months ago. According to Korea Democratic Pharmaceutical Union, a former employee at the company has received a letter of dismissal on Apr. 16. Three days after convening the disciplinary committee, the former employee has been informed of the dismissal and the decision was publicly opened as a ‘personnel order’ via company email. According to the employment regulation, the affected employee was supposed to be able to request for an appeal and practice the right to receive reassessment. But the labor union argues the company officially announcing the dismissal even before the appeal is an unfair labor practice. Head of Lundbeck Korea Chapter Lee Kyung-Soo said, “When firing our member of the union, the management did not inform the union. The company is clearly trying to oppress the labor union,” and “many of us employees are feeling oppressed and intimidated by the company disregarding the basic right of defense and unjustly handling the dismissal.” The labor union is demanding the company to sincerely apologize to the employees. At the negotiation table a month ago, apparently, the union representatives stated, “The protest would be halted without any other condition, if the company acknowledges its fault.” The union plans to take the justification of the disciplinary action to Regional Labor Relations Commission and National Labor Relations Commission. Reportedly, the labor union officials are working on the affected former employee’s relief application with the Regional Labor Relations Commission and the former employee is also individually following up with a legal procedure. The labor union’s picketing was seemingly subsiding when it was temporarily suspended last month. But it resumed in five days and today marks the 50th day. The union claims their fight against the company resumed as the company did not deliver the promise. Lee reproached, “The HR sent out another email elaborating the incident, but it was not an apology but it was deceiving the labor union and employees. The management has notified the union the negotiation would not be conducted unless the outside office protest is ended. And they have not even started salary and employee benefit negotiation for 2020, yet.” However, the company management says otherwise. The reason behind the employee dismissal cannot be disclosed, but they claim the procedure was done by the book. The employee was not eligible to join the union, and it was irrelevant to the labor union suppression as the decision was made after a long discussion with the headquarters. A Lundbeck Korea insider explained, “A personnel order is applicable after the first decision is made by the disciplinary committee. The management thought the news of dismissal had to be disclosed as soon as possible to prevent a gap in work flow.” The insider added, “As it was an unprecedented personnel decision made ever since the Lundbeck Korea was established, we understand the confused sentiment of the employees. But their claim that the company is oppressing the employees is unacceptable,” and “unless the union stops the protest, the negotiation would not be conducted properly.”
- Company
- Accelerating the market entry of JAK inhibitors
- by Kim, Jin-Gu Jun 10, 2020 06:08am
- JAK inhibitors, oral rheumatoid arthritis drugs, are increasing sales in the autoimmune disease treatment market. Xeljanz (left) & Olumiant However, the major item Xeljanz (Tofacitinib) is faltering. For the first time, quarterly sales fell. It is an analysis that the growth of Olumiant(Baricitinib) had an effect. In addition, generics such as Smyraf (Peficitinib) and Rinvoq (Upadacitinib) will begin in earnest, the competition for the JAK inhibitor market is expected to intensify. According to the drug research agency IQVIA on the 8th, the sales of JAK inhibitors in the first quarter amounted to ₩5.4 billion. It has grown more than 6 times in three years from ₩800 million in the first quarter. JAK inhibitors are known as oral rheumatoid arthritis drugs. It is evaluated that it has overcome the limitations of the most widely used TNF alpha inhibitors in the market for autoimmune diseases. It was pointed out that TNF alpha inhibitors are injections despite expanded indications. The main indication is rheumatoid arthritis, which is more limited than a TNF alpha inhibitor. However, last year, Xeljanz is expanding its scope by adding indications for ulcerative colitis and psoriatic arthritis. In addition, studies on atopic dermatitis, Crohn's disease, ankylosing spondylitis are also reported to be in progress. Among the related products, sales in the first quarter were ₩3.9 billion for Xeljanz and ₩1.5 billion for Olumiant. However, the recent sales changes have led to the first quarterly decline in Xeljanz. It decreased by 4% to ₩4.9 billion in the fourth quarter of 2019, On the other hand, luminescent increased 44% from 1 billion won to 1.5 billion won during the same period. It is reported that in the fourth quarter of last year, it surpassed Xeljanz in the prescription share of new patients. The gap between the two is expected to be further narrowed if Olumiant acquires indications for atopic dermatitis. Quarterly sales of Xeljanz & Olumiant (Unit:₩100 million, Source: IQVIA) In January, Astellas' Smyraf (Peficitinib) was approved by the MFDS. On the 4th, Abbvie's Rinvoq was approved. Both products are expected to enter reimbursement categories within this year, unless there is a big deal. Some products are waiting to be released. Gilead Sciences completed the clinical phase III of Filgotinib last year, and is currently applying for a product license in the United States, Europe and Japan. Pfizer is targeting atopic dermatitis and is conducting Phase III clinical trial of the second JAK inhibitor, PF-04965842.
- Company
- Rinvoq was approved in Korea
- by Eo, Yun-Ho Jun 09, 2020 06:28am
- Domestic market competition among JAK inhibitors is fierce. According to the related industry, Pfizer's Xeljanz (Tofacitinib), Lilly's Olumiant (Baricitinib), Astellas' Smyraf(Peficitinib) and Abbvie’s Rinvoq (Upadacitinib) were approved on the 4th. Rinvoq's permission is based on five phase III SELECT clinical trials (SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE, SELECT-EARLY) involving 4,443 patients with moderate to severe active rheumatoid arthritis. As a result of phase III clinical trials, Rinvoq showed lower disease activity and improved clinical remission rate compared to placebo, MTX or Humira (Adalimumab) group when used alone or in combination with conventional synthetic DMARD (csDMARD). However, it is not yet as effective as biological products in the market. Relatively, indications of JAK inhibitors are limited in areas other than rheumatoid arthritis. Xeljanz, which was first developed, added indications such as ulcerative colitis and psoriatic arthritis last year, and Generics are also under study to expand indications for autoimmune diseases such as atopic dermatitis, Crohn's disease, and ankylosing spondylitis. If the commercialization of Gilead's Filgotinib, which is in the process of approval in the United States and Europe, is achieved, the market size of the JAK inhibitor itself with the convenience of oral medication is also expected to expand. Meanwhile, these JAK inhibitors have the same mechanism of blocking inflammatory cytokine signaling pathways JAK (enzymes such as JAK1, JAK2, JAK3, TYK2, etc.), but there are detailed differences. Xeljanz blocks JAK1 and JAK3, and Olumiant blocks JAK1 and JAK2, and Smyraf blocks JAK1, JAK2, JAK3 and TYK2. Rinvoq & Filgotinib are related to JAK1.
- Company
- Will COVID-19 Vaccine be specially imported?
- by Kim, Jin-Gu Jun 09, 2020 06:26am
- The government is reviewing the vaccine being developed by AstraZeneca as a special import for COVID-19. Although it is still in the development stage, it is said that the government and the company had contacted with the plan to urgently introduce it in the form of special import if the clinical trial succeeds. According to the pharmaceutical industry on the 5th, officials from the MOHW and AstraZeneca Korea from South Korea held a meeting once in Seoul. It is confirmed that In-taek Lim, director of the Health Industry Policy Division, participated in this meeting. The two sides discussed the progress of the clinical trial of the DNA vaccine currently being developed by the Jenner Institut in the UK. The government previously decided to make a special import for Gilead Science's “Remdesivir”, which is being developed as a treatment for COVID-19. In addition, the government is also considering ways to specially import the COVID-19 vaccine developed by AstraZeneca and developed by the Jenner Institut at Oxford University in the UK. Currently, major companies and organizations that are developing COVID-19 vaccines include CanSino Biologics in China, Moderna Therapeutics, and Inovio Pharmaceuticals in the United States. The Jenner Institut started late, but it was the fastest to develop. It predicts that vaccine production will be possible as early as September this year. The reason that the Jenner Institut was able to speed up this is because safety was confirmed in clinical trials of vaccines developed for the prevention of MERS, the same coronavirus disease last year. It is said to have been successful in animal tests conducted this year in the case of COVID-19 vaccine. The clinical trial scale is also the largest. The clinical trial phase I was launched on April 24, and the number of participants reached 1,100. It overwhelms the clinical trials of other companies and institutions. In the case of Moderna and Inovio, which had entered clinical trials earlier, dozens of participants were conducted in Phase I trial. In May, it was approved by the British government to conduct Phase II/III trials simultaneously. The size of the clinical trials are about 5000. AstraZeneca plans to produce a vaccine that can be dosed by 2 billion people worldwide by as early as September, assuming that the trial will be completed successfully. Pascal Soriot, CEO of AstraZeneca in an interview with an American press, said, "We plan to introduce vaccines to the United States and the United Kingdom from September or October." AstraZeneca and the government have been in a good relationship since President Moon Jae-in's visit to Sweden last year. In June of last year, President Moon Jae-in visited Sweden and met with Leif Johansson, Chairman of AstraZeneca. Chairman Johansson promised to invest $630 million in Korea over the next five years. In December of last year, Chairman Johansson visited Cheongwadae with an economic mission headed by Swedish Prime Minister Stefan Löfven. Through the visit, Chairman Johansson reaffirmed his commitment to invest $630 million, and specified the investment market. If the COVID-19 vaccine is successfully commercialized, it is expected that Korea's special imports will be proceeded well.
- Company
- Customized Rx considering the patient's condition is needed
- by Eo, Yun-Ho Jun 08, 2020 06:13am
- The need for patient-specific prescriptions is emerging in the field of obesity treatment. At the recently held 'Saxenda e-Class' (Saxenda.livesympo.com), Professor Hye Jin Chun of the dept. of Family Medicine at Cha University Bundang Medical Center had a time to cover information about treatment for obesity. On this day, Professor Hye Jin Chun focused on six types of obesity treatments including Saxenda (Liraglutide), Xenical (Orlistat), Dietamin (Phentermine), Qsymia (Phentermine+ Topiramate), Belviq (Lorcaserin), Contrave (Naltrexone HCl/ Bupropion) that passed the approval standards of the MFDS. Of these, drugs that have been approved by the US FDA and European EMA are Saxenda, Xenical, and Contrave. She said, "In the case of appetite suppressants that act on the central nervous system, such as Phentermine or Phentermine/Topiramate combinations, anxiety or depression may worsen in patients taking psychiatric drugs, and attention to suicidal behavior is necessary. The prescription is contraindicated for patients who are mentally very anxious or excited." Saxenda was the preferred treatment option for these patients. Prof. Jeon said, "Saxenda is 97% similar to GLP-1, an appetite regulating substance in the human body that is naturally secreted in response to food intake, and is an obesity treatment that has confirmed efficacy and safety through long-term clinical data for 3 years." Saxenda's globally licensed clinical trials show that 63% of patients with an overweight loss of 5%, 33% of patients with weight loss of more than 10%, and 14% of patients with weight loss of more than 15%, 9 out of 10 Showed weight loss effect. In addition, it was the only obesity treatment to obtain indications in obese patients with pre-diabetes, and it proved the effect of improving various metabolic risk factors such as blood sugar, blood pressure, and blood lipid levels in addition to weight loss. Professor Jeon also introduced a case study of a patient who actually lost weight through Saxenda. The patient was a woman in her 50's and was overweight with a BMI of over 32kg/m2. At the time of the first treatment, she showed resistance to injection treatment, enjoyed a late night snack, and had a high craving for food, so Contrave was prescribed, but after 4 days of taking, she complained of severe headache and nausea, and changed the drug to Dietamin. After 2 weeks of treatment, the weight was slightly reduced, but the prescription drug was changed to Saxenda by complaining of insomnia, dry mouth and throbbing, which are typical characteristics of Phentermine. She also complained of stomach discomfort and proceeded to increase slowly than the basic increase schedule as she administered Saxenda and lost weight to 28.3kg/m2 BMI through Liraglutide combination with improved lifestyle. Professor Jeon said, “It is necessary to guide patients who visit hospitals for obesity treatment by identifying drugs that can be prescribed for a long period of time so that patients can be prescribed safe treatments. Safe and effective treatment must be achieved through the proper application of drugs based on the evidence."
- Company
- Celltrion, begins development of Insulin pen biosimilar
- by An, Kyung-Jin Jun 08, 2020 06:11am
- View of CelltrionCelltrion is working with a domestic medical device company to develop an insulin biosimilar. The goal is to secure cost competitiveness and lower dependence on imports by developing a pen-type insulin injection for the first time in Korea. Celltrion’s insulin pipeline was selected as a state-designated project by the Korea Evaluation Institute of Industrial Technology (KEIT). The four-year development will require a total budget of ₩4 billion, of which ₩3 billion will be supported by the government. The two companies focused on developing a pen-type injection that can be automatically administered up to 80 units once. The intention is to commercialize domestic insulin pen-type injections using domestic materials. Celltrion is in charge of insulin biosimilar development and clinical trials, and Poonglim Pharmatech plays a role in charge of developing an auto pre-filled pen type injector that can be used by filling in biopharmaceuticals developed by Celltrion. It will be commercialized by 2025 through four years of research and development. Currently, 96 percent of the global insulin market is taken by Sanofi, Eli Lilly and Novo Nordisk. Biosimilar products are also sold only by Sanofi and Lilly. In the domestic insulin market, there were many opinions that the localization of the product was urgent as Novonordisk occupied 45%. The national assignment project evaluation committee is also known to give a high score to reduce the dependence on imports if 'Korea's No. 1' product with quality and cost competitiveness is released in consideration of such market conditions. Half out of an estimated 463 million global diabetic patients use pen injectors, Celltrion said, adding that the market is annually growing by 9 percent. By 2023, the pen insulin market size is predicted to hit ₩37 trillion. An official from Celltrion said, “The selection of the target for this national project is the result of the recognition of the technological development innovation of both companies and the know-how and development of the market in the future.” "We expect diabetic patients around the world to benefit from more convenient treatments at lower cost."
- Company
- Unpredictable Cancer Committee make all kinds of decisions
- by Eo, Yun-Ho Jun 05, 2020 06:10am
- The expression on all the pharmaceutical companies accepting the final outcome varied as the meeting concluded. But for sure, no one had a perfect game. On June 3, Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee was convened to discuss two immunotherapies, two poly ADP-ribose polymerase (PARP) inhibiting targeted therapies and two multiple myeloma treatments. ◆ Keytruda and Opdivo The decision on MDS’s Keytruda (pembrolizumab) has been deferred yet again. The Committee reviewed granting reimbursement on Keytruda’s five indications, including first-line treatment (monotherapy and combination therapy) for non-small cell lung cancer (NSCLC), monotherapy for second or later-line treatment in bladder cancer, and monotherapy for third or later-line treatment in or refractory classical Hodgkin lymphoma. In the April meeting finally convened after being postponed twice due to COVID-19, the Cancer Committee deferred the decision on the immunotherapy. Although not required, the multinational company submitted an economic evaluation data and financial impact solution plan on using the immunotherapy as a first-line treatment (mono and combination therapy) in patients with non-small cell lung cancer (NSCLC) to better express its commitment to receive the extended reimbursement. Regardless, the committee did not give a satisfying answer, explaining that they did not have sufficient time to review properly. Bristol Myers Squibb (BMS) and Ono’s Opdivo (nivolumab), on the contrary, gave up on the lung cancer indication and won the benefit in Yervoy (ipilimumab) combination therapy. Apparently, BMS and Ono have also submitted an economic evaluation data to secure the coverage on Opdivo plus Yervoy combination therapy. In April, the Cancer Committee cleared the reimbursement on Opdivo for a second-line therapy for relapsed or metastatic head and neck squamous cell carcinoma (HNSCC) and a second-line therapy for classical Hodgkin lymphoma (CHL), but denied the indication on second-line renal cell carcinoma therapy and third-line stomach cancer therapy. And at the latest meeting, the committee gave a nod to Opdivo’s indication to treat renal cell carcinoma as a first-line therapy. After receiving the first reimbursement as a second-line therapy in patients with NSCLC in September 2017, Opdivo has taken three years to pass the Cancer Committee. ◆Lynparza and Zejula Without a surprise, the Cancer Committee’s answer to PARP inhibitor’s indication on BRCA-negative patients was ‘no.’ AstraZeneca’s Lynparza (olaparib) and Takeda Pharmaceutical’s Zejula (niraparib) were half-successful in the end. The Cancer Committee reviewed Lynparza’s tablet indicated to as a maintenance therapy following a first-line therapy in patients with BRCA-mutated advanced ovarian cancer, second or later-line treatment in platinum-sensitive patients with relapsed high grade serous epithelial ovarian, treatment in patients with HER2-negative metastatic breast cancer. The committee recognized the need for first and second-line maintenance therapy in BRCA-mutated ovarian cancer, but ruled out mBRCA-negative patients included in the second-line therapy indication. Also, the committee seemed skeptical of the breast cancer indication. Zejula also had a similar outcome. The review was on using the drug as maintenance therapy of patients with gBRCA-negative high-grade serous relapsed ovarian cancer who showed complete or partial response in platinum-based chemotherapy, and as monotherapy in patients with relapsed ovarian cancer who previously received fourth-line or later chemotherapy. Ultimately, only the fourth-line monotherapy indication was approved, while the gBRCA-negative indication failed. The government is still conservative about an anticancer treatment indicated to treat ‘all comers.’ ◆ Revlimid and Pomalyst Multiple myeloma treatments seem to be struggling with maintenance therapy. Deferred by the Cancer Committee last September, Revlimid (lenalidomide) once again requested a review on extended coverage on a maintenance therapy to prevent relapse in patients who had stem cell transplantation, which was not granted. The combined company of Bristol Myers Squibb (BMS) and Celgene offered a financial impact solution plan for the coverage on the maintenance therapy indication, but the committee did not change its mind. However, the committee green-lit the reimbursement on Pomalyst (pomalidomide) as a second-line therapy, extended from the current coverage on third-line therapy. Specifically, the approval was granted on the Pomalyst, Velcade (bortezomib) and dexamethasone combination therapy in patients with multiple myeloma, who have previously received one or more treatment including Revlimid. With the latest approvals, BMS and Celgene combined have received approval on two out of three items in the first Cancer Committee meeting held since their merge.
- Company
- General Hospitals to prescribe AbbVie Skyrizi with coverage
- by Eo, Yun-Ho Jun 05, 2020 06:10am
- General hospitals are ready to prescribe now listed Skyrizi, the fourth interleukin inhibitor in the Korean market. Pharmaceutical industry sources reported drug committees (DC) at Korea University Ansan Hospital, Soonchunhyang University Bucheon Hospital, Design Hospital, Gangnam Severance Hospital, Dankook University Hospital, Hallym University Kangnam Sacred Heart Hospital and Korea University Guro Hospital have cleared interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab) for the treatment of patients with severe psoriasis. Skyrizi has been listed for National Health Insurance (NHI) reimbursement from June 1. The coverage would be granted to patients with chronic psoriasis at a severe level expressed for over six months, who show symptoms of plague psoriasis on 10 percent and more of their body surface area, score 10 or higher on Psoriasis Area and Severity Index (PASI) and demonstrate no reaction to three months of or longer administration of methotrexate (MTX) or cyclosporine or cannot maintain the therapy due to adverse reaction, or demonstrate no reaction despite receiving UVB phototherapy for over three months or cannot maintain the therapy due to adverse reaction. From now on, Korea’s interleukin inhibitor drug market would be divided among four competitors including Novartis’ IL-17A inhibitor Cosentyx (secukinumab), Lilly’s IL-17 inhibitor Taltz (ixekizumab) and Janssen’s IL-23 inhibitor Tremfya (guselkumab), as well as Skyrizi. All four drugs have been first approved as a psoriasis treatment, but they are respectively expanding their indications in autoimmune disease sector. Professor Youn Sang Woong of Department of Dermatology at Seoul National University Bundang Hospital said, “Skyrizi has outstanding benefit in skin condition improvement, safety and convenience, which would greatly help patients to achieve their most wanted goal of maintaining clean skin for a long time.” Skyrizi has confirmed efficacy and safety in treatment through four clinical trials including UltIMMa-1, UltIMMa-2, IMMvent and IMMhance studies. The UltIMMa-1 and UltIMMa-2 studies found 75 percent of patients using Skyrizi have reached 90 percent skin improvement (PASI 90) at week 16, and 36 percent and 51 percent of patient groups in respective studies have shown 100 percent skin improvement (PASI 100). Analyzing the patients who received Skyrizi during the two trials, the treatment effect in most of the patients who demonstrated PASI 90 and PASI 100 has been maintained even after a year.
- Company
- Immunotherapy Keytruda faces Cancer Committee once again
- by Eo, Yun-Ho Jun 05, 2020 06:09am
- An immunotherapy Keytruda would be standing before the Cancer Deliberation Committee once again. On June 3, Keytruda (pembrolizumab) would be deliberated by Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee again, although the committee deferred the decision in a meeting finally held on Apr. 29 after COVID-19 postponing the schedule twice. The Cancer Deliberation Committee reviewed granting reimbursement on Keytruda’s five indications, including as a first-line treatment (monotherapy and combination therapy) for non-small cell lung cancer (NSCLC), monotherapy for second or later-line treatment in bladder cancer, and monotherapy for third or later-line treatment in or refractory classical Hodgkin lymphoma. In March 2017, Keytruda monotherapy has been approved as a first-line treatment in patients with NSCLC. And the MSD Korea has submitted an application for reimbursement approval on the monotherapy indication to be used as a first-line treatment in September 2017, and continued the talk with the government for over two years. Regardless of the effort, the talks fell through in September last year. Considering the health authority’s decision, MSD showed its commitment by submitting unasked-for economic evaluation data on the first-line treatment in NSCLC to seek for the reimbursement expansion. But the Cancer Deliberation Committee rather demanded additional data on reducing the cost and deferred the decision. Accordingly, MSD has revised the financial impact resolution plan once again for technically the last negotiation. If Keytruda fails to pass the Cancer Committee this time, the coverage extension discussion on the immunotherapy would highly likely to get pushed aside indefinitely. Keytruda was listed for the first time in August 2017 through a combination of refund and expenditure cap type risk sharing agreement (RSA) based on the PD-L1 expression rate as a standard. The drug is even trying to replace existing first-line chemotherapy option with the immunotherapy as a monotherapy. This holds a significant meaning. If the coverage expansion is granted, then a patient diagnosed with stage IV lung cancer, not subject for targeted therapy with EGFR mutation, could be prescribed with Keytruda.
- Company
- Janssen revs up 2 new global trials on lazertinib
- by An, Kyung-Jin Jun 04, 2020 06:14am
- Janssen’s novel anticancer treatment lazertinib licensed out from Yuhan is initiating a new global clinical trial. Prior to a global phase 2 trial, the multinational company is accelerating the investigational drug’s commercialization process with other phase 1 trials. According to a clinical trial registration website ‘clinicaltrials.gov’ by the U.S. National Institutes of Health (NIH) on June 2, Janssen has registered two global phase 1 trials attached to lazertinib. One is an open-label study to investigate absorption, metabolism and excretion of administered 14C-lazertinib and another is assessing effects of CYP450 3A4 inhibitor itraconazole or CYP450 3A4 inducer rifampin on lazertinib. Both trials are testing the drug in healthy adults. Lazertinib, in development as a non-small cell lung cancer (NSCLC) treatment, aims to evaluate its tolerance, safety and pharmacokinetics. The two trials are scheduled to conclude in coming November, but they have not started calling for participants. In 2018, Yuhan licensed out a third generation epidermal growth factor receptor (EGFR) targeted therapy lazertinib to Janssen Biotech. The novel drug is evaluated to have potency to be a second-line treatment in NSCLC patient who developed T790M mutation after taking existing EGFR targeted therapy or a first-line treatment in NSCLC patient who has EGFR mutation. Janssen is currently focused on investigating the potency of combining lazertinib and a bispecific antibody targeted therapy amivantamab that the company started developing after licensing in lazertinib. A large-scale global clinical trial evaluating the amivantamab plus lazertinib combination therapy has started by calling for participants from September last year. By early this year, the trial participant size increased from 400 to 460 and moved up the end point to June 2022. The trial would proceed to next stage when the recommended phase 2 dose (RP2D) is decided. Johnson & Johnson (J&J) has appointed amivantamab and lazertinib as a promising pipeline of the pharmaceutical sector and drew up a blueprint to complete the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) by 2023. The latest registration of the clinical trials could be interpreted as the company consolidating their commitment to commercialize lazertinib. Yuhan, on the other hand, could receive massive milestone payment again within this year with the combination therapy’s phase 2 trial in full motion. In November 2018, Yuhan has signed lazertinib license-out deal with Janssen Biotech and received an upfront payment of USD 50 million (approximately 55 billion won). The Korean company recently received milestone payment of 35 million dollars for the amivantamab combination therapy phase 2 trial. 18 months into the deal, the company generated 85 million dollars. When lazertinib is successfully commercialized, the Korean company would receive up to 1.25 billion dollars for achieving milestones.
