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- 2026-05-08 21:37:26
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- Commercialization of ADC Enhertu is imminent in Korea
- by Eo, Yun-Ho Jun 02, 2022 05:58am
- The HER2-directed antibody-drug conjugate (ADC) ‘Enhertu’ is expected to be commercialized in Korea soon. According to inducts sources, Daiichi Sankyo Korea and AstraZeneca Korea’s human epidermal growth factor receptor 2 (HER2)-directed antibody-drug conjugate (ADC) ‘Enhertu (trastuzumab deruxtecan),’ is expected to be approved within this year. Enhertu, which has indications for breast and gastric cancer, was jointly developed by AstraZeneca and Daiichi Sankyo and was first approved for the treatment of recurrent metastatic HER-positive breast cancer in the U.S. in 2019. Afterward, Enhertu was additionally approved in the US for the treatment of locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received prior standard treatment with ‘Herceptin(trastuzumab).’ The drug was also granted the Breakthrough Therapy Designation (BTD) in the US, and is referred to as a second-generation ADC. As Roche’s ADC ‘Kadcyla (trastuzumab emtansine)’ failed to demonstrate its efficacy in gastric cancer, the expectations in the field have been rising on the possibility of prescribing Enhertu in gastric cancer. Although HER2 protein is generally expressed in breast cancer, it is also found in some other types of cancer. One out of five gastric cancer patients in the U.S. is diagnosed with advanced HER2-positive gastric cancer. The efficacy of Enhertu in gastric cancer was demonstrated through the Phase II DESTINY-Gastric01 trial. In the study, 26 patients were randomly assigned to receive Enhertu or the investigator’s choice of chemotherapy (paclitaxel or irinotecan) that was administered by intravenous infusion every 3 weeks. The clinical trial on gastric cancers was conducted on patients with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction cancer whose disease had progressed after he/she had received at least two previous regimens including Enhertu and fluoropyrimidine-based chemotherapy. Results showed that the median overall survival (OS) in the Enhertu group was 12.5 months, which was superior to 8.4 months in patients that received the investigator’s choice of therapy. The Objective Response Rate (ORR) was 40.5% in the Enhertu group and 11.3% in the paclitaxel or irinotecan group. The median duration of confirmed objective response was 11.3 months in the Enhertu group, demonstrating its efficacy compared to the 3.9 months in the group that received the investigator’s choice of therapy. Meanwhile, the Ministry of Drug and Food Safety is reviewing the results of the DESTINY-Breast01 trial that evaluated the drug’s efficacy in the third or later line treatment of metastatic stage patients, and expansion of Enhertu’s approval in the second line will take place in the future.
- Company
- Evusheld to be introduced in Korea
- by Eo, Yun-Ho May 31, 2022 06:06am
- The introduction of the COVID-19 prevention drug Evusheld in Korea has been confirmed. The KDCA supplementary budget of 4.9083 trillion won was confirmed yesterday (29th), which includes securing a shortage of living support, paid vacation expenses, quarantine hospitalization, and home treatment expenses due to a surge in confirmed cases. The government has decided to spend 39.6 billion won of the budget to introduce a new 20,000 doses of Evusheld by AstraZeneca, an antibody treatment for the purpose of preventing COVID-19 infection and severe immunity. As a result, Evusheld, the first antibody complex for preventing the COVID-19 in Korea, is expected to be prescribed to immunodeficiency patients. However, it is believed that the subject of administration will be limited. The government limited Evusheld to patients undergoing severe immunosuppressive treatment who necessarily needed preventive antibody treatments. Those with a history of COVID-19 confirmation were also excluded. As a result of the report, it was confirmed that the health authorities expressed their intention to discuss increasing the use of reserve funds in consideration of the future epidemic situation and the need to expand the number of subjects and re-administration. The U.S. FDA approved Evusheld last December. European EMA confirmed its introduction in March. In addition, France, Australia, and Singapore have completed pre-purchase contracts for Evusheld for the purpose of preventing COVID-19. An official from AstraZeneca said, "We hope it will help immunodeficiency patients such as blood cancer and organ transplant patients who were in the blind spot of COVID-19 prevention, and we will continue to do our best to provide smooth domestic supplies." Through various studies published in Nature Medicine, it has been confirmed that Evusheld is the only anti-antibiotics that maintain neutralization activity against omicron mutations. As a result of phase 3 PROVID study, Evusheld reduced the risk of symptomatic COVID-19 infection by 77% compared to placebo in the first analysis, and the risk was reduced by 83% in 6-month follow-up. During the 6-month follow-up period, there were no severe or fatal cases in the Evusheld medication group. More than 75% of the subjects who participated in the study had comorbid diseases that are likely to develop into severe diseases in the event of COVID-19, such as weakened immune systems at the time of baseline or did not show sufficient immune response to vaccination.
- Company
- Handok to “speed up global P2T for its BTC candidate"
- by Kim, Jin-Gu May 31, 2022 06:05am
- Handok Pharmaceuticals announced on the 30th that it had recently received approval to change the clinical trial protocol for its candidate, 'ABL001(CTX-009),' which the company is developing as a treatment for biliary tract cancer, to expand the trial overseas into a global clinical trial. ABL001 is a next-generation anticancer drug that was developed using a bispecific antibody platform technology. Handok has signed a licensing agreement with ABL Bio and owns the domestic rights for the drug. The company has been concentrating on studying the ABL001's efficacy on biliary tract cancer since February 2021 and led Phase II trials for the drug in Korea. Handok explained that it has established the grounds for global expansion in its domestic clinical trial. Handok’s affiliate, the US bioventure Compass Therapeutics, had received FDA approval on its IND to initiate a Phase II trial on ABL001 based on the clinical trial results from Korea in January this year. The two companies plan to work together on the Phase II trial that will be conducted in the US under the same protocol as the trial being progressed in Korea. The Phase II trial on ABL001 studies the coadministration of ABL001 and paclitaxel in patients with biliary tract cancer. Patients who have unresectable advanced, metastatic or recurrent biliary tract cancer who underwent two lines of systemic chemotherapy were enrolled in the trial. Young-Jin Kim, CEO of Handok Pharmaceuticals, said, “During our trial, we secured significant data on the partial remission and tumor reduction effect of ABL001. With the global clinical trial of ABL001 beginning in earnest, we will make our best efforts to bring ABL001 into the market as a new alternative for patients in need."
- Company
- PalPal's sales are 5.1 billion won
- by Kim, Jin-Gu May 31, 2022 06:05am
- Hanmi PharmaceuticalHanmi Pharmaceutical is about to win the market for erectile dysfunction treatments. While "PalPal," the No. 1 item in the existing market, was leading, third-place Gugu chased second-place Chong Kun Dang's Cendom. According to IQVIA, a pharmaceutical market research institute, on the 28th, the domestic erectile dysfunction treatment market in the first quarter was 27.7 billion won. It increased by 9% compared to 25.4 billion won in the first quarter of last year. Most of the major products also saw their sales increase year-on-year. Hanmi Pharmaceutical's PalPal, which maintains its market lead, increased 2% from 5 billion won in the first quarter of last year to 5.1 billion won in the first quarter of this year. PalPal is Viagra's generic. Chong Kun Dang's Cendom, the second-largest product in the market, increased 6% from 2.5 billion won to 2.7 billion won during the same period. The third-largest product, Hanmi's Gugu, rose 22% from 2.1 billion won to 2.5 billion won. In the case of Gugu, sales growth is the largest among products with quarterly sales of more than 1 billion won. Cendom and Gugu are Lilly's generic for Cialis. With the rapid growth of Gugu, the gap with Cendom has also narrowed significantly. Three years ago, in the first quarter of 2019, the gap between Cendom and Gugu reached 1 billion won, 2.7 billion to 1.7 billion won, but the gap between the two decreased to 200 million won as Gugu quickly expanded its influence. Last year, Cendom and Gugu posted sales of 10.8 billion won and 9.1 billion won, respectively. If Gugu overtakes Cendom and rises to the second-largest product, Hanmi Pharmaceutical will be the company with both the first and second-largest products in the erectile dysfunction treatment market. Hanmi Pharmaceutical will dominate generics for Viagra and Cialis markets. Hanmi released PalPal shortly after the expiration of its Viagra patent in 2012. PalPal has maintained its lead for six years since it surpassed Viagra in the second quarter of 2013 and Cialis in the fourth quarter of 2015. Since the expiration of patent of Cialis in 2015, Gugu has been growing rapidly. Gugu surpassed Cialis in the second quarter of 2019, and overtook Viagra in the second quarter of last year. Following this, it is closely chasing Cendom, the existing second-largest product. Original products are struggling as generic is doing well around PalPal and Gugu. Viagra recorded 2.3 billion won in sales in the first quarter of this year. Compared to 2.5 billion won in the first quarter of 2019, which was three years ago, it is estimated to have decreased by 8%. Cialis also saw its sales fall 14% from 1.7 billion won to 1.5 billion won in three years.
- Company
- Obesity treatment market expands 66% in 4 yrs
- by Chon, Seung-Hyun May 30, 2022 05:42am
- The obesity treatment market continues to grow with the launch of new products. The size of the new market has expanded by more than 60% over the past four years. According to IQVIA, a pharmaceutical research institute, on the 29th, the size of the obesity treatment market in the first quarter was 35.7 billion won, up 11.3% year-on-year. The domestic obesity treatment market is continuously on the rise, growing 66.4% in four years from 21.4 billion won in the first quarter of 2018. Quarterly obesity treatment market size (left) and sales of Saxenda/Qsymia (right) trend (unit: 100 million won, data: IQVIA) The recent growth of the obesity treatment market is driven by new products Saxenda and Qsymia. Saxenda, which was released in Korea in 2018, is the world's first obesity treatment approved as a GLP-1 (Glucagon-Like Peptide 1) similar. The ingredients are the same as those prescribed for type 2 diabetes patients, but only the usage and dose are different. Saxenda ranked first in the obesity treatment market with sales of 5.6 billion won in the fourth quarter of 2018. Then Saxenda is leading the way for 14 consecutive quarters until the first quarter. Sales rose 54.7% to 10.4 billion won in the first quarter. Growth has slowed somewhat since hitting 10.9 billion won in the fourth quarter of 2019, but it has recently risen sharply again, surpassing 10 billion won in quarterly sales in nine quarters. The perception that Saxenda is relatively safe was formed because it acts as the same mechanism as GLP-1 in the human body to suppress appetite and reduce weight. Qsymia, which was released at the end of 2019, is combination of Pentermine and Topiramate that Alvogen Korea secured domestic copyright from Vivus in 2017. Alvogen Korea signed a joint sales contract with Chong Kun Dang at the end of 2019 and started selling it in Korea in earnest. Qsymia has recorded more than 5 billion won in sales since the third quarter of 2020. Sales reached 6.3 billion won in the first quarter, up 7.1% from the previous year. Qsymia analyzed that Alvogen Korea and Chong Kun Dang's sales power, which have a wide sales network in the domestic obesity treatment market through sales experience such as Furing and Furimin, quickly penetrated the market. Even though it is a PO formulation, the fact that it has relatively low psychotropic drug content and can be prescribed for a long time is also considered a success factor. Qsymia once closely pursued Saxenda and established a two-way system in the obesity drug market. Qsymia's sales in the first quarter of last year were 5.9 billion won, with a gap of only 800 million won from Saxenda. The gap between the two products is widening as Saxenda has recently recorded rapid growth again. The gap between Saxenda and Qsymia widened to 3 billion won in the second quarter of last year and further widened to 4.1 billion won in the first quarter of this year. Saxenda accounted for 29.1% of the total obesity treatment market in the first quarter, up 8.1% from 21.0% a year earlier. Qsymia market share fell to 17.8% from 18.4% in the first quarter of last year. Daewoong Pharmaceutical's two products, Dietamin and Hutermin, exceeded 1 billion won in sales in the quarter. Dietamin and Hurtamin recorded 1.9 billion won and 1.2 billion won in sales in the first quarter, respectively, showing a decline compared to the previous year.
- Company
- Interleukin inhibitor market doubles in 2 years
- by May 30, 2022 05:41am
- Sales of interleukin inhibitors that are used to treat autoimmune diseases such as psoriasis have increased over twofold in 2 years. 1st generation drugs including Stelara, Cosentyx, Tremfya, and Skyrizi have all shown even growth. Market analysts have evaluated that the use of IL inhibitors has increased with the steady expansion of their indications. According to the market research institution IQVIA on the 27th, the IL-17/23 inhibitor class market size had increased 41.4% YoY to reach ₩28.7 billion in Q1 this year. IL inhibitors, which are mainly used to treat psoriasis, can be classified into IL-17 and IL-23 class drugs. The first mover in the market, Stelara concurrently targets IL-12 and IL-23. Its developer Janssen then released Tremfya as a follow-up that solely targets IL-23. Abbvie’s Skyrizi is also an IL-23 inhibitor. Novartis’s Cosentyx and Lilly’s Taltz are IL-17 inhibitors. With the introduction of such latecomers, the interleukin inhibitor market continued to repeat its growth every quarter. Starting with ₩13.8 billion in Q1 2020, sales rose to ₩15.3 billion in Q2, ₩18.2 billion in Q3, and ₩18.4 billion in Q4. Quarterly sales exceeded ₩20 billion for the first time last year, and by the previous quarter, the amount more than doubled to reach ₩28.7 billion in just two years. Janssen’s Stelara continues to show high growth 10 years after its approval. Its sales in Q4 last year exceeded ₩10 billion in quarterly sales. Its sales in Q1 this year were ₩10.1 billion, a 33.7% YoY increase. The indication of Stelara was expanded from psoriasis to psoriatic arthritis to Crohn's disease, then ulcerative colitis. As a result, its yearly sales exceeded ₩30 billion for the first time last year. Stelara’s sales which had been ₩26.9 billion in 2020 rose 34.2% last year to record ₩36.1 billion. Other more effective latecomer drugs have been introduced to the market, but Stelara continues to exert its potential as the only drug indicated for Crohn's disease and ulcerative colitis. Stelara is followed by the IL-7 inhibitor Cosentyx. Cosentyx made ₩7.5 billion in sales in Q1 last year. This is a 32.7% YoY increase. Novartis had increased patient convenience with a self-administered Cosentyx Sensoready Pen formulation that has a concealed needle. Cosentyx is the first IL-17 inhibitor to expand its indication to ankylosing spondylitis. The drug may also be used in non-radiographic axial spondylarthritis that comes before ankylosing spondylitis. Janssen’s Stelara follow-on IL-23 inhibitor Tremfya raised ₩5.8 billion in sales in Q1. This is a 45.2% YoY growth from Q1 last year. Janssen is working quickly to expand the indication of its follow-up Tremfya to replace Stelara before Stelara’s patent expiry. Tremfya’s indication was expanded from psoriasis to psoriatic arthritis, and the drug also acquired approval as a treatment for palmoplantar pustulosis, an indication unique to Tremfya. Abbvie’s Skyrizi, a drug in the same class as Tremfya, recorded ₩3.5 billion in Q1 this year, growing 166.0% YoY compared to the same period of the previous year. Although the drug’s sales size may seem less than other drugs, its quarterly sales exceeded that of Taltz’s. Skyrizi was the last to enter the market among IL inhibitors. It is yet only approved to treat psoriasis and psoriatic arthritis. However, the drug has been carrying out aggressive marketing activities with the strength of its convenience in administration as it requires the least number of administrations. Lilly’s Taltz was the only IL inhibitor to show stalled growth. Taltz’s sales, which were ₩1.7 billion in Q1 last year, recorded ₩1.8 billion in Q1 this year, showing little difference. Quarterly sales of the drug had remained at a ₩1.7 billion ₩1.8 billion level. The IL-17 inhibitor Taltz has the same indication as the same-class drug Cosentyx but its sales have been overtaken by Cosentyx in the market.
- Company
- Samjin recently filed a request against Janssen Korea
- by Kim, Jin-Gu May 30, 2022 05:41am
- Samjin has challenged Janssen's patent for the treatment of pulmonary arterial hypertension (Micronized Macitentan). In the past, generic companies have challenged Opsumit patents in all directions, but it has resulted in failure, drawing keen attention to the success of Samjin's challenge. According to the pharmaceutical industry on the 26th, Samjin recently filed a request against Janssen Korea for a passive confirmation of the scope of rights for the Opsumit patent. Opsumit is currently protected by two patents. It is material patent that expires in March 2023 and a pharmaceutical patent that expires in October 2027. Among them, Samjin's strategy is to avoid the patent for the drug that expires in 2027 and then release the generic in time for the expiration of the patent for materials in March 2023. Interestingly, generic companies have challenged Opsumit patents in the past. Huons, Intro Biopharma, and Alboven Korea simultaneously requested a passive judgment on the scope of rights and invalidation of material patent for Opsumit in 2015, and a trial for invalidation of the patent for sanctions. But this challenge failed. All three companies were rejected in the invalidation challenge for material patents, followed by the voluntary withdrawal of material patents and the invalidation challenge for pharmaceutical patents. The only way to challenge patent for Opsumit is to avoid the patent. Opsumit is a treatment for pulmonary hypertension developed by Actelion. In Korea, Janssen Korea is selling it. It has grown into a product that generates 10 billion won in sales since it was approved in 2014. According to IQVIA, a pharmaceutical market research firm, Opsumit's sales were 16 billion won last year. It recorded 4.3 billion won in sales in the first quarter of this year.
- Company
- The release of Singrix for NIP is expected
- by Moon, sung-ho May 30, 2022 05:41am
- Since the launch of the new government, the shingles vaccine market, called "a vaccine that is filial to parents," has been fluctuating. This is why global pharmaceutical companies are expected to release blockbuster vaccines in Korea in the second half of the year at a time when shingles are widely expected to be included in the NIP. According to the pharmaceutical industry and the medical community on the 20th, President Yoon Seok-yeol made a campaign pledge to "free vaccination of shingles vaccine over 65" when he was a candidate, drawing keen attention to whether it will be implemented Currently, the shingles vaccines distributed in Korea are SK Bioscience's Sky Zoster and MSD's Zostavax. On top of that, GSK's Singrix, which was approved by the Ministry of Food and Drug Safety in September last year as a potential competitor, is scheduled to be released in the second half of the year. The vaccines of SK Bioscience and MSD, which are currently used on the market, are live vaccines that are inoculated once to those aged 50 or older, and the prevention effect is more than 60%. Sky Zoster is prescribed at hospitals and clinics at a price of around 100,000 won and Zostavax at around 100,000 won. If President Yoon Seok-yeol fulfills his pledge, chances are high that these shingles vaccines will be included in the NIP. With sales of shingles vaccines plunging due to COVID-19 over the past two years, the inclusion of NIP acts as a good news for these pharmaceutical companies. This is because if these shingles vaccines are included in the NIP, they can recover their fallen sales. Related companies are paying attention to whether to include the shingles vaccine NIP. According to drug research agency IQVIA, Sales of Sky Zoster and Zostavax last year fell to 18.2 billion won and 27 billion won, respectively, compared to the previous year. Sales in 2020 were 29.1 billion won and 43.2 billion won, respectively, with sales of both items falling 38% in common. "As President Yoon Seok-yeol announced that he would include shingles vaccine in NIP as a pledge at the time of the election, related companies such as SK Bioscience have no choice but to expect it to be another breakthrough at a time when clinical results are scheduled to be released in the second half." As GSK's shingles vaccine Shingrix is confirmed to be released in Korea in the second half of the year, the atmosphere in the hospital and hospital markets is expected to heat up even more. In the case of Shingrix, the prevention effect is more than 90%, which is excellent compared to the existing vaccine. It is an inactivated vaccine, so it needs to be injected twice, and it is expected to be more expensive than the existing vaccine. Since it is called a "good-for-nothing vaccine," it is interpreted that the fact that it is rather "high-priced" may serve as a competitiveness in the medical field. Director A of otolaryngology in Gyeonggi-do, an executive of the otolaryngology association, said, "Current clinical studies show that Shingrix has an outstanding preventive effect compared to existing vaccines," adding, "Personally, I've been waiting for Shingrix and a really good vaccine has been released. Thanks to the marketing of the filial piety vaccine, it can work positively for patients. GSK is in last-minute consultations with domestic pharmaceutical companies over sales and marketing ahead of the launch of Shingrix. The pharmaceutical industry predicts that domestic sales and marketing partners will be "GC Pharma," but related companies say that it has not been decided. Another domestic company official said, "With Shingrix joining Sky Zoster and Zostavax in the second half of the year, whether to apply NIP will act as another variable in the market," adding, "If the introduction of shingles NIP becomes a reality, it could act as another competitiveness for existing items."
- Company
- Expanded indication for Jardiance
- by jung, sae-im May 29, 2022 05:15pm
- The SGLT-2 inhibitor Jardiance expanded the indication to HFpEF. Beringer Ingelheim Korea and Lilly Korea announced on the 26th that Jardiance has been approved by the MFDS to expand its indication as a treatment for chronic heart failure regardless of left ventricular contraction function (hereinafter referred to as heart rate). Jardiance was approved by HFrEF last November. It is expanded by preserving the cardiac output rate, and it can be used to treat patients with chronic heart failure regardless of the cardiac output rate. Heart failure is divided into reduction, vigilance, and preservation according to heart rate. The ejection rate is reduced by less than 40%, the boundary is 40 to 50%, and more than 50% is considered conservation. There have been no drugs that encompass both reduction and preservation of the ejection rate. Jardiance has become the first and only drug in Korea. The number of heart failure patients in Korea is about 1 million, accounting for about 50% of all heart failure patients with HFpEF. Heart failure with preserved heart rate has a high prevalence rate and patients' prognosis is not good, but there have been no clinically effective treatments. Jardiance demonstrated efficacy and safety in phase 3 clinical studies of EMPEROR-Preserved in patients with cardiac output retention heart failure (HFpEF). Clinical results in 5,988 heart failure patients showed that Jardiance reduced the relative risk of hospitalization due to cardiovascular death or heart failure, a primary evaluation variable, in adult chronic heart failure patients with preserved heart rate, regardless of diabetes. Second-order evaluation variable analysis not only reduced the relative risk of first and re-admission due to heart failure by 27%, but also delayed the reduction of glomerular filtration rate (eGFR), an indicator of renal dysfunction. Jardiance's overall safety profile was consistent with previous clinical trial results. The standard for administration of patients with renal impairment in type 2 diabetes was also eased. Previously, patients with type 2 diabetes with eGFR of less than 60 ml/min/1.73 m could not start treatment with Jardiance. With this change, patients with eGFR 45ml/min/1.73m can also start treatment with Jardiance. In patients with renal impairment with chronic heart failure, Jardiance can be used if the eGFR is 20ml/min/1.73m or higher. This was set in the same way as the standard for patients with heart failure with reduced cardiac output, whose indications were approved in November.
- Company
- Lorviqua, which is about to be reimbursed, has settled
- by Eo, Yun-Ho May 29, 2022 05:15pm
- The third-generation ALK inhibitor Lorviqua has settled in the Big Five Hospital. According to related industries, Lorviqua of Pfizer Korea passed the Drug Committee of Big 5 (DC), excluding Seoul St. Mary's Hospital such as Samsung Medical Center, Seoul National Cancer Center, and Chung-Ang University Hospital. As the adequacy of insurance benefits was recognized by the Drug Benefit Evaluation Committee last month after passing the first HIRA Cancer Disease Review Committee in January, it is expected to be quickly linked to actual prescriptions if the registration of Lorviqua is confirmed. It remains to be seen whether Pfizer, the first developer of ALK anticancer drugs, will be able to increase its market share. This drug was designated as a rare drug in March last year, and in July, it was approved in Korea for use when Alecensa or Zykadia was previously treated with a primary ALK inhibitor or Xalkori and at least one other ALK inhibitor as a treatment. The third-generation drug, Lorviqua, can be an alternative to patients with subsequent resistance, such as the first-generation drug, Xalkori, and the second-generation drugs, Zykadia and Alecensa. If Xalkori was used in the primary therapy, Lorviqua could be used after the second generation drug, and if the first generation drug was used, Lorviqua could be used in the second. Until now, if resistance developed in secondary drugs, chemotherapy had to be used because there was no target treatment available. G1202R is the most common resistance mutation after second-generation drug treatment, and depending on the drug, F1174L (Zykadia), I1171T/N/S (Alecensa), and E1210K (Alunbrig) appear. Lorviqua works on all known resistant mutations. Lorviqua has added indications of primary therapy for non-small cell lung cancer in Europe. The approval was made based on the results of a phase 3 CROWN study. In this study, Lorviqua demonstrated improvement efficacy in indicators such as death risk and ORR compared to Xalkori.
