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- 2026-03-17 16:20:01
- Company
- A single tech export brings in 11 times the annual revenue
- by Chon, Seung-Hyun Jan 13, 2022 06:05am
- The biotechnology company ABL Bio signed a mega-deal and secured 11 times its annual revenue through a single license agreement. Its upfront payment by itself ranks in the top 5 among the technology export deals made by pharmaceutical and biopharmaceutical companies in Korea. When excluding the ones that have returned the rights, ABL Bio’s deal is the third-largest in upfront payments. According to the Financial Supervisory Service on the 12th, ABL Bio signed a license agreement with Genzyme for ABL301, a bispecific antibody candidate for the treatment of Parkinson's disease and other neurodegenerative diseases. Genzyme is a fully owned subsidiary of Sanofi. Under the agreement, after ABL Bio completes the preclinical and Phase I clinical trial for ABL301, Sanofi will be responsible for further clinical development and receive worldwide exclusive development and commercialization rights to ABL301. ABL will receive up to $1.06 billion (approx. ₩1.3 trillion) under the agreement. ABL will first receive $75 million (approx. ₩90 billion) in upfront payment with no obligation for return and will be eligible to receive up to $45 million in near-term milestones, as well as up to $985 million (approx. ₩1.2 trillion) based on the achievement of predefined development, regulatory and commercialization milestones. ABL301 is a novel drug candidate that inhibits aggregation of α-synuclein, which causes Parkinson’s disease. Through the agreement, ABL Bio secured an amount 11 times that of its sales revenue of ₩8.1 billion in 2020 through a single technology export. ABL Bio’s ₩8.1 billion in 2020 were also profits made from technology transfer. ABL Bio posted sales of ₩1.3 billion and ₩4 billion in 2018 and 2019, respectively, both of which were also profits made from technology transfers. The upfront payment secured by ABL Bio this time ranks the company in the Top 5 among all technology exports made by domestic pharmaceutical companies. The amount shows how highly Sanofi considers the commercial value of ABL301. Hanmi Pharmaceutical holds the largest record of upfront payment made through technology export deals in Korea. In November 2015, Hanmi Pharmaceutical had entered into a license agreement with Sanofi to transfer the license of its 3 new diabetes drugs (Efpeglenatide·long-acting insulin·Efpeglenatide+long-acting insulin). The upfront payment, which was first set at 400 million euros and later reduced to 240 million, still ranks first among all upfront payments made for technology exports in Korea. Hanmi Pharmaceutical’s deal with Janssen for its long-acting diabetes-obesity drug ranks second in upfront payments ($150 million). Third is SK Biopharm’s epilepsy treatment cenobamate, which has received $100 million in upfront payment upon signing an agreement with Able Therapeutics. Fourth is again Hanmi Pharmaceutical, which had received $80 million through a licensing agreement with Genentech for its RAF inhibitor in 2016. ABL Bio’s ABL301 ranked fifth with $75 million in upfront payments. One unfortunate aspect is that 5 of the top 10 items that received the most in upfront payments were returned. In December 2015, Sanofi had discontinued development and returned the rights for the long-acting insulin among the 3 candidate drugs it acquired from Hanmi for its Quantum Project. Also, the agreement was then changed so that Hanmi develops the long-acting insulin combo (long-acting insulin+ efpeglenatide) for Sanofi’s acquisition in the future, but Sanofi did not take over in the end. The rights for Hanmi Pharmaceutical’s new candidate drug for obesity/diabetes 'JNJ-64565111,’ which accrued the second-most amount in upfront payment, has also been returned in September 2019. The license for Hanmi’s ‘olmutinib’ was also returned in 2016, and the immune disease treatment that was handed to Eli Lily was also returned in 2019. Dong-A ST’s partner company also gave up the development of Dong-A ST’s Mer tyrosine kinase inhibitor (Mer TKI). Among technology export agreements still in effect, SK Biopharm’s cenobamate has received the most amount in upfront payment with $100 million. ABL Bio’s ABL301 ranks third among technology exports that are still in effect.
- Company
- Viatris & J&J hired female executives
- by Eo, Yun-Ho Jan 12, 2022 06:05am
- Executive Director Kim Ji-young (left) and Executive Director Hwang SeonghyeExecutive-level personnel in charge of multinational pharmaceutical's external cooperation department are active. According to related industries, Viatris Korea appointed Kim Ji-young (52 years old), former executive director of Janssen Korea, as the head of the dept. of Foreign Cooperation in December last year, while Johnson & Johnson Korea (J&J) will appoint Hwang Sung-hye (50), former executive director of Pfizer, this month. Viatris Korea recruited Kim Ji-young, executive director of Corporate Affairs & Market Access, as her predecessor Lim Hyun-jung (45) moved to the head of the marketing department. Executive director Kim led Janssen Corporation and Patient Affairs for 10 years and was in charge of overall communication in the pharmaceutical industry, including disease communication, environmental creation and patient support, and CSR. Graduated from the Department of Archaeological Art History at Seoul National University, she obtained a master's degree in communication at the University of North Carolina in 2000 and also oversaw the promotion and external cooperation teams of Janssen in Taiwan and Hong Kong. Previously, she worked as a reporter for Maeil Business Newspaper and Hankook Ilbo for 20 years. As former Vice President Song Young-joo (62) became an advisor to BKL as of the 7th, J&J recently decided to appoint Hwang Sung-hye as executive director of Government Affairs & Policy. Hwang joined Pfizer Public Affairs in 2008, served as the General Manager of Corporate Affairs and Market Access of the dept. of Foreign Cooperation, and has even marketing experience. Graduated from Yonsei University's Department of Newspaper Broadcasting, she earned a master's degree in economics at Sogang University and a master's degree in business administration at Rouen ESC in France and worked as a reporter for the Chosun Ilbo. Until just before the turnover, executive director Hwang led Pfizer's MA team. Meanwhile, with Kim's move, Janssen is looking for a new general manager of the external cooperation team, and Pfizer also started hiring Market Access with Hwang's resignation.
- Company
- Keytruda-Renvima has been approved as the primary treatment
- by Jan 12, 2022 06:05am
- MSD Korea announced on the 11th that a combination therapy of anti-PD-1 immuno-cancer drug Keytruda (Pembrolizumab) and Lenvima (Lenvatinib) has been approved by the MFDS as the primary treatment for advanced new cell carcinoma. Combination therapy of Keytruda and Lenvima in renal cell cancer treatment recorded 23.9 months of mPFS and improved OS in a phase 3 clinical CLEAR study. Studies have shown that Keytruda-Lenvima reduced the risk of disease progression or death by 61% (HR=0.39) compared to Sunitinib. The risk of death was reduced by 34% (HR=0.66). The overall survival period did not reach the median value. Keytruda-Lenvima's objective response rate (ORR) was 71%, significantly higher than that of the Sunitinib group of 36%. CR recorded 16%, 4%, and PR recorded 55%, and 32%, respectively. The most frequently observed adverse reactions in clinical practice are diarrhea and high blood pressure. In addition, clinical evidence for Keytruda's endometrial cancer indication was added. Phase 3 clinical data that succeeded in progressive endometrial cancer for the first time in 50 years has been added. Phase 3 KEYNOTE-775/Study 309 study found that Keytruda-Lenvima reduced the risk of death by 32% (HR=0.68) compared to chemotherapy (Doxorubicin or Paclitaxel). The risk of disease progression or death decreased by 40% (HR=0.60). In addition, the median survival period of the combined group was 17.4 months, which was statistically significantly improved to 12 months of the chemotherapy group. The median PFS was significantly longer at 6.6 months and 3.8 months, respectively. Kim Sung-pil, executive director of MSD Korea anticancer drug division, said, "This permit is a result of proving the excellent clinical profile of Keytruda-Lenvima."
- Company
- Reducing # of sales positions of pharmaceutical companies
- by Moon, sung-ho Jan 12, 2022 06:04am
- It was found that the number of personnel engaged in the control and bio industries has steadily increased over the report showed. However, amid the boom in pharmaceuticals and bio, the position of sales workers is decreasing day by day. Analysts say this is because it is concentrated on the development of online sales and marketing and contract manufacturing organizations (CMO). According to the KPBMA on the 11th, the number of people engaged in the pharmaceutical and bio industries has steadily increased over the past 10 years, reaching 1,398 companies and 114,126 in 2020. Considering 823 companies and 74,477 people in 2011, it doubled. Such an increase in pharmaceutical and bio-industry workers was led by production workers. The number of production workers exploded from 23,539 in 2011 to 46,166 in 2020. As a result, the proportion of production workers among all pharmaceutical and bio-industry workers also increased from 31.6% to 40.5%. Analysts say that this was an opportunity for large bio companies such as Celltrion, Samsung Biologics, and SK Bioscience to expand their CMO businesses by increasing production facilities before and after the COVID-19 pandemic. Sales positions, which have been key in pharmaceutical and bio-industry jobs, have been greatly reduced over the past 10 years. This is because the size of the sales position remained in place while the number of production workers doubled during the same period. The total number of sales jobs in 2020 was 25,317. Considering that there were 24,535 people in 2011, it is safe to say that it remains the same. The percentage of sales positions decreased from 32.9% in 2011 to 22.2% in 2020. In fact, as the proportion of production workers has increased, the proportion of sales workers has decreased. The industry seems to predict that the proportion of sales jobs will decrease over the years. They say that the position will inevitably decrease as consignment production of medicines, utilization of Contracts Sales Organization (CSO) by mid-sized pharmaceutical companies, and the spread of online sales and marketing are major factors. Some predict that large-scale movements of pharmaceutical sales workers will take place amid the growth of the digital healthcare industry. This is because in the digital healthcare sector, like in the pharmaceutical and bio sectors, hiring sales personnel is essential as its use in hospitals and clinics is directly related to the increase in sales. Digital healthcare companies that develop EMR or medical AI solutions are increasing their employment as sales workers at pharmaceutical companies. Company A, which is developing EMR, is hiring "someone who wants to sell data technology, not oral drugs," while company B is hiring people with experience in sales at university hospitals at the team leader level. An executive of a domestic pharmaceutical company, a former doctor who asked for anonymity, said, "It is now difficult to grow with the operation method of a traditional pharmaceutical company that relies on generic sales centered on face-to-face sales." As consignment production of medicines is suggested as an alternative to growth, traditional pharmaceutical companies are also focusing their capabilities on developing new drugs and producing drugs, he explained.
- Company
- Pharmaceutical bio jobs to be reorganized
- by Chon, Seung-Hyun Jan 12, 2022 06:04am
- Jobs in the pharmaceutical bio industry have increased by more than 50% in the past nine years. The number of production workers surged. In recent years, it is analyzed that many jobs have been created in production jobs as pharmaceutical bio companies have greatly increased production facilities and expanded their CMO business. The proportion of sales jobs in all jobs dropped sharply. According to the 2021 Pharmaceutical Bio Industry Data Book published by the KPBMA on the 10th, the total number of employees in the pharmaceutical bio industry in 2020 was 114,126, an increase of 10.9% year-on-year. It increased 53.2% in nine years from 74,477 in 2011. # of employees in the pharmaceutical bio-industry by year (unit: # of employee, data: the KPBMA) Jobs in the pharmaceutical bio industry have increased every year since 2011. Analysts say that the pharmaceutical bio-industry has recently shown growth and is playing a significant role in creating jobs. Looking at the current status of jobs by major task, the number of production workers has increased significantly. In 2020, the number of production employees was 46,166, an increase of 24.1% from the previous year. It doubled in nine years from 25,539 in 2011. The share of production workers in the entire pharmaceutical bio industry expanded from 31.6% in 2011 to 40.5% in 2020. In 2011, sales workers accounted for the largest portion of all employees, but in 2020, the proportion of production employees exceeded 40%. It is analyzed that the number of production jobs has increased significantly recently as production facilities have increased significantly and CMO businesses have expanded, especially among bio companies. Founded in 2011, Samsung Biologics is currently operating three biopharmaceutical plants in Songdo, Incheon. Samsung Biologics is building its fourth plant with the aim of operating it in 2023. The fourth plant is the largest ever with 256,000 liters of production. When the fourth plant is in operation, Samsung Biologics will secure a total of 618,000 liters of production facilities along with its third plant (3,000 liters of first plant, 152,000 liters of second plant, and 180,000 liters of third plant). As of the end of 2020, the number of production workers at Samsung Biologics was 1,255, an 87.6% increase from 669 in 2016. In other words, the number of production jobs has nearly doubled in four years. Celltrion and SK Bioscience also saw a significant increase in the number of production workers due to the recent surge in biopharmaceutical production. Samsung Biologics, Celltrion, and SK Bioscience all surpassed 100 billion won in quarterly operating profit, leading the growth of the entire pharmaceutical bio industry. The proportion of sales jobs in the pharmaceutical bio industry has decreased significantly. In 2020, the number of sales employees was 25,317, down 1.0% from the previous year. Sales jobs were the only ones among all jobs that saw a year-on-year. The number of sales employees increased only 3.2% over the past nine years from 24,535 in 2011 to 25,317 in 2020. Sales accounts for more than 10% of all jobs from 32.9% in 2011 to 22.2% in 2020. Although the pharmaceutical bio-industry is growing, the proportion of sales jobs is also expected to decrease as sales activities are relatively less important. Analysts say that sales activities based on scientific evidence have increased significantly rather than salespeople's supply offensive. Some say that the need for salespeople to visit medical institutions in person has been reduced as the proportion of non-face-to-face work such as online marketing has decreased significantly since the recent spread of COVID-19. The proportion of office and research jobs did not change significantly. The proportion of office workers increased by 1.5% from 19.4% in 2011 to 20.9% in 2020, while the number of research workers decreased by 0.1% from 11.8% to 11.7% during the same period.
- Company
- Soliris at risk of price cuts amid increasing PA rejections
- by Moon, sung-ho Jan 12, 2022 06:04am
- The National Health Insurance Service has selected ‘Soliris (eculizumab)’ as a ‘subject for PVA monitoring’ and began monitoring its claims amount, believing that its use has increased over a certain level. However, all of the prior authorization applications for the same drug had been rejected last month. In other words, the drug is double trouble as it is being assessed for price cuts due to its increased claims amount while being rejected for reimbursement in its prior authorization applications. According to the industry on the 6th, the NHIS had selected and informed companies of the drugs under the Price-Volume Agreement that will be evaluated in the first quarter of 2022, including Soliris. The PVA system is a means for the NHIS and the pharmaceutical company to share the amount of rising drug cost that is applied to drugs whose usage increases rapidly. After negotiations with the NHIS, the company needs to maintain the use volume that it has agreed upon to avoid price cuts. Therefore, drugs that are found to have been used over that certain level according to the NHIS’ claims amount may be subject to price cuts, being subject for the adjustment of its upper limit. Soliris is also known to have been caught under NHIS’ radar for exceeding the claims amount. If the NHIS deems that Soliris’ use volume has increased after monitoring its case, the authorities will conduct negotiations with its company, Handok, and push for price cuts. An NHIS official said, “We will be selecting subjects for negotiations after monitoring the evidence. Soliris is also one of the drugs being monitored. The drugs up for monitoring this time are those whose claims have increased by 30% or more or those that have increased over 60% annually during the compared period or by over 10%‧5 billion won.” However, one thing to note is that Soliris’s applications for prior authorization are being being continuously disapproved for reimbursement by the NHIS. Soliris is currently indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). However, due to the high price of the drug – which costs 5.13 million won per vial – the MOHW and HIRA had set a hurdle that requires prior authorization for insurance benefit when approving the drug for reimbursement. And according to HIRA, all 3 of the prior authorization applications (2 new, 1 re-deliberation case) made for Soliris that were deliberated by the Healthcare Review and Assessment Committee in November last year were rejected. All 3 applications were for the use of Soliris in aHUS. For aHUS treatment, only 3 of the 47 applications filed for prior authorization last year were approved and administered to patients. As a result, although Soliris is not being administered much due to the series of disapprovals by NHIS during the prior authorization review, the drug is still subject to monitoring for price cuts due to its expanded indication that raised the claims amount. HIRA explained, “The applications were denied after reviewing the supplementary medical records that were submitted because the subjects were not eligible for administration as specified in the notice and were determined to have secondary thrombotic microangiopathy that was caused by drugs such as immunosuppressants.”
- Company
- Ultra-high-priced ‘Kymriah’ is up for DREC deliberations
- by Eo, Yun-Ho Jan 11, 2022 06:29am
- Whether the new CAR-T therapy ‘Kymriah’ will be applied insurance benefit is receiving wide attention. According to industry sources, the world’s first chimeric antigen receptor T-cell (CAR-T) therapy ‘Kymriah' will be deliberated as an agenda by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee on the 13th of this month, 3 months after the agenda passed the Cancer Disease Deliberation Committee in October last year. Specifically, the drug is indicated for ▲ adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy, and ▲ patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (B-ALL) that is refractory or in second or later relapse Reimbursement listing of Kymirah is currently the biggest and hottest issue in the industry as this ‘one-shot’ treatment may cure cancer with a single administration but costs up to 500 million won per shot. The company had been going through the reimbursement process for Kymriah since it was approved in March last year through the ‘approval-reimbursement review linkage system.’ Although it was first set an agenda for CDDC deliberation in September, the committee deferred their decision. Immediately upon the news of deferral, the Korea Leukemia Patients Organization strongly criticized the government and the pharmaceutical company. The KLPO had before criticized the authorities over the delay in Kymriah’s agenda being put up for deliberation by the CDDC. Despite overcoming the CDDC obstacle, whether Kymriah will be able to complete its reimbursement journey to the end remains unknown. The CDDC may have passed the Kymriah agenda to DREC pressured by the intense attention focus around the agenda. Therefore DREC’s role is expected to be an important observation point that will play a key role in the listing process. Meanwhile, the CDDC had set the reimbursement standards for Kymriah so that the following conditions should be met for its reimbursement: ▲the company should bear a higher-level risk in consideration of the price level in other countries, ▲a risk-sharing system based on a performance-based payment model that pays according to treatment performance of each patient for relapsed or refractory diffuse large B cell lymphoma (DLBCL) as it has a poorer clinical outcome compared to acute lymphoblastic leukemia, and ▲an expenditure cap should be set on the total expenditure allowed for Kymriah. In other words, the key to the reimbursement listing of Kymriah depends on the fiscal sharing plan submitted by Novartis’ Korean subsidiary and its determination in persuading its head office.
- Company
- Keytruda's reimbursment to be deliberated at DREC meeting
- by Eo, Yun-Ho Jan 10, 2022 05:56am
- The immuno-oncology drug ‘Keytruda’ is finally on its next step to reimbursement after passing Cancer Disease Deliberation Committee's review. According to industry sources, reimbursement expansion of MSD Korea’s PD-1 inhibitor Keytruda (pembrolizumab) will be deliberated by the National Health Insurance Service’s Drug Reimbursement Evaluation Committee on the 13th of this month. Keytruda was able to finally reach the DREC doorsteps, six months after the agenda passed the CDDC meeting last July and four years after it first applied for the reimbursement expansion to its indications including as first-line treatment in non-small cell cancer (NSCLC) Since MSD failed to put the agenda up for deliberation at the DREC meeting that was held last November, the company had expressed its will to complete that and the pricing negotiations with NHIS within that year but was unable to make progress even in December of the same year. However, although the CDDC had passed the agenda, it had once again mentioned the need for equity with Tecentriq to MSD and requested additional revision to the company’s fiscal sharing plan. Therefore, the industry's eyes are on what the DREC results will be. At the time, MSD Korea’s Managing Director Kevin Peters had said, “The company is deeply aware of the urgency felt by the many lung cancer patients and HCPs during the past 4 years while awaiting reimbursement of Keytruda in first-line lung cancer. We are focusing all efforts on internal and external discussions so we could proceed with relevant procedures as quickly as possible after CDDC deliberations.” The biggest barrier to expanding reimbursement for Keytruda was the ‘pharmaceutical company taking the burden of the initial 3 cycles’ worth of administration cost’ requested by the government to companies with immunotherapy agents. Roche Korea, which owned the then-latecomer ‘Tecentriq (atezolizumab),’ was the only company to accept the government’s proposal, and 2 types of PD-1 inhibitors – Keytruda and ‘Opdivo(nivolumab)’ were unable to accept the offer and has not been approved for the reimbursement extensions until now.
- Company
- Heads of 4 MNCs were newly appointed last year… increase of
- by Eo, Yun-Ho Jan 07, 2022 06:06am
- (From the left) GMs Byungjae Yoo, Martin Corcoll, Cherry Huang, So Eun Kim Four multinational pharmaceutical companies have appointed new CEOs over the past year. According to Dailypharm’s update of CEOs in 32 major multinational pharmaceutical companies, including the Korean Research-based Pharmaceutical Industry Association, heads of 4 pharmaceutical companies were replaced or newly appointed last year. Most were regular personnel appointments mainly due to term of office expiry, with others due to CEO’s relocation or corporate spin-offs. ◆ Novartis·BI·Janssen’s appoints new head due to term expiry… New launch of Organon First, companies such as Novartis Korea, Boehringer Ingelheim, and Janssen Korea welcomed new heads to their office due to the expiration of the term of office of former CEOs or promotions. Novartis appointed Byungjae Yoo, former Managing Director of Johnson & Johnson Medical North Asia to succeed Joshi Venugopal who made a promotional transfer to Novartis headquarters. Boehringer Ingelheim Korea appointed Martín Coroll, former general manager of Boehringer Ingelheim Austria, to lead the office after Steven Walter’s term expiry. In Janssen’s case, Janssen Korea appointed Cherry Huang as the next CEO of Janssen Korea in June to take place after the former CEO Jenny Zhuang moved to head its Chinese subsidiary. Huang had previously served as the CFO of Janssen Asia Pacific. Just as Viatris Korea entered the industry in 2020, Organon Korea spun off from MSD Korea in 2021 and launched as a new and separate company. In line with its new establishment, the company appointed So Eun Kim as its first Managing Director. Since entering MSD Korea in 1998, Kim had served various roles in MSD Korea and abroad for 23 years. ◆17%, a record-high proportion of local CEOs…rate of women CEOs exceed 30% 2021 is also a significant year in that the proportion of women and Korean CEOs recorded the highest-ever within Korean subsidiaries of multinational pharmaceutical companies. In particular, this will be the second time since its establishment that a Korean subsidiary of Novartis will be managed by a local CEO. Since its establishment in 1997 and the first president Frans Hompe, the company had mostly appointed foreign heads to lead the Korean subsidiary. The only Korean national that had previously been appointed was Hak-sun Moon in 2015. In addition, Organon also appointed a Korean women head with its establishment. Moderna Korea, which entered the Korean market with the development of its COVID-19 vaccine, also added weight to the proportion of women CEOs by appointing Ji-Young Sohn as the new General Manager. Meanwhile, Sang Wook Kang, CEO of GSK Consumer Healthcare resigned. Due to Kang’s unexpected resignation, the company is currently being operated under an acting representative system.
- Company
- Ahn to reduce generic price to counter Lee's hair loss reimb
- by Kim, Jin-Gu Jan 07, 2022 06:06am
- Cheol-Soo Ahn, the presidential candidate of the minor opposition People's Party, pledged to reduce the price of hair loss drug generics. Ahn prosed this as an alternative in concern over the worsening insurance finances that may be caused by Democratic Party Jae-Myung Lee’s mention of reimbursing hair loss treatments On the 5th, Ahn criticized Lee’s pledge of reimbursing hair loss drugs through his social media channel. “How will you manage the soon to be depleted NHI finances? It would only lead to a hike in insurance premiums.” He added, “Reimbursement is not the only solution. We can reduce the people’s price burden significantly without using NHI finances if we reduce the price of hair loss drug generics by 30-40%.” In the case of finasteride drugs that are used for hair loss, the original drug ‘Propecia’ costs around 1,800 to 2,000 won per tablet. Propecia's generic ‘Monad’ currently costs 1,500 won per tablet. Ahn claims that reducing the generic’s price to around 600-800 won per tablet can greatly reduce patient burden without spending NHI finances. Ahn said, “In the US, if there are 19 generics in market, a drug’s price may fall to 6% of the original drug's price at the lowest,” stressing the need to reduce the price of generics for all pharmaceuticals in general, including hair loss treatments. Ahn also promised to support the research and development of hair loss treatments. Ahn said, “The 56 trillion won global hair loss treatment market is growing over 4% every year. If we provide significant support for the R&D of new drugs for hair loss treatment, it would benefit industry development as well as contribute to providing a more economic option for those suffering from hair loss.”
