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- 2026-03-17 02:03:10
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- Emgality passes DREC review… what about Ajovy?
- by Eo, Yun-Ho Jun 07, 2022 06:04am
- With Emgality nearing insurance reimbursement in Korea, what path Ajovy will walk is also gaining attention. Teva-Handok Pharma had applied for the reimbursement of its calcitonin gene-related peptide (CGRP) targeting migraine drug Ajovy (fremanezumab) earlier this year. However, Ajovy’s reimbursement was not deliberated as an agenda at the DREC meeting that was held in May this year, the same meeting at which Emgality (galcanezumab) passed deliberations. The gap could be reasonable when considering Emgality applied for reimbursement in March last year, but as the reimbursement discussion period for the two drugs had coincided somewhat, the industry had predicted that the two agendas will be deliberated at the same time, but saw different results. As a result, the company is awaiting DREC deliberation on the reimbursement of Ajovy and is in discussion with the HIRA. Both drugs are currently prescribed without reimbursement. Although Emgality and Ajovy are same class drugs, they differ in dosage and administration, allowing patients to be prescribed the drugs according to their individual characteristics. Emgality is administered in a loading dose of 240mg (two consecutive subcutaneous injections of 120 mg each) followed by monthly doses of 120mg injected subcutaneously. Ajovy is administered in a monthly dosage of one 225 mg subcutaneous injection each month or a quarterly dosage of 675mg subcutaneous injection (three consecutive 225mg injections) every 3 months. Ajovy demonstrated its efficacy at the HALO EM/CM clinical trial that was conducted for 12 weeks on 2,000 episodic migraine (EM) and chronic migraine (CM) patients. In the HALO EM study that was conducted to verify the efficacy and safety of Ajovy in comparison to placebo, Ajovy met the primary endpoint by significantly reducing the monthly number of migraine days in both the monthly and quarterly dosed groups. The proportion of patients with a 50% reduction in migraine days was also higher for the Ajovy administered group than the placebo group. The proportion of subjects that showed a 50% or more reduction in migraine days was 47.7% in the monthly Ajovy and 44.4% in the quarterly Ajovy group, compared to the 27.9% in the placebo group. In the HALO CM study, the monthly average reduction in migraine days in the monthly dosing Ajovy group was 4.6±0.3 days, and the quarterly dosing Ajovy group was 4.3±03 days, a significant reduction compared to the placebo group’s 2.5±0.3 days. WonGu Lee, Professor of Neurology at Kosin University Hospital, said, “Unlike existing preventive drugs that required daily dosage, patients may manage their migraines with once-a-month injection with CGRP-targeted antibody drugs. The treatment cost remains an issue, however, we neurologists have high expectations for these drugs because the more the patient receives the targeted therapy, the easier it is to treat.”
- Company
- Cumulative sales of Spinraza in 3yrs is ₩200 billion
- by Chon, Seung-Hyun Jun 07, 2022 06:03am
- Spinraza, a rare disease treatment, posted 200 billion won in sales over the past three years after registering health insurance benefits. Although there is not much demand, it has achieved high performance in a short period of time due to the nature of expensive treatments worth nearly 100 million won per bottle. According to IQVIA, a pharmaceutical research firm, on the 3rd, Biogen's Spinraza sold 17.4 billion won in the first quarter, up 18.3% from the same period last year. Although it is less than 20.2 billion won posted in the first quarter of 2020, it has recorded 10 billion won in quarterly sales for three years since the second quarter of 2019. Quarterly Spinraza Revenue (Unit: 100 million won, Data: IQVIA) Spinraza is a rare disease treatment called SMA that treats neuromuscular genetic diseases in which muscles contract due to damage to spinal cord and brainstem motor neurons. SMA is a disease that has normal cognitive functions, but it is difficult to live a normal life, such as low muscle tension and contraction of tongue muscles. Spinraza, which received domestic permission in December 2017, was listed at an upper limit of 92.35 million won per bottle (5 ml) in April 2019 after negotiating the price of drugs with the NHIS. Spinraza made 10.2 billion won in sales in the second quarter of 2019 when it was listed on the health insurance benefit list. It recorded sales of 20.4 billion won and 15.9 billion won in the third and fourth quarters of 2019, respectively, and sold 46.4 billion won in the first year of the registration. Spinraza recorded sales of 10 billion won to 20 billion won in the quarter, showing sales of 72 billion won and 61.3 billion won in 2020 and last year, respectively. The cumulative sales raised after the registration totaled 7.1 billion won. Based on the high price of nearly 100 million won per bottle, it made a lot of sales in a short period of time. The size of the market has not expanded significantly because the number of patients is not large and a difficult procedure that requires prior review before administration.
- Company
- Bio USA to be held offline for the first time in 3 years
- by Kim, Jin-Gu Jun 03, 2022 06:37am
- The Bio International Convention (BIO USA),’ which is known as one of the largest global events in the biotechnology industry, is set to be held in San Diego USA from the 13th to the 16th of this month. Twenty or more pharma and bio companies in Korea including Samsung Biologics, Celltrion, SK Pharmteco, and Lotte Biologics are planning to attend this first offline event held in 3 years since 2019. According to industry sources on the 3rd, over 3,000 companies have registered to attend Bio USA online and offline. Bio USA is a global bio event that is being held for the 29th time this year. After 2019's event that was held in Philadelphia, the event was held online for two consecutive years. This year will mark the first event that will be held offline in 3 years. In particular, 20 domestic pharmaceutical companies have expressed their will to physically attend the event. Samsung Biologics, Celltrion, SK Pharmteco, and Lotte Biologics have prepared separate booths to interact with other pharma-bio companies around the world. Also, the Korean booth that will be jointly operated by Korea BIO and KOTRA will make known the names of 16 other domestic companies. One company that is receiving particular interest is Lotte Biologics. Lotte had announced its plan to enter the bio business at the group level. The company acquired BMS’s manufacturing facility which is located in Eastern New York for $160 million (approx. ₩200 billion). Also, the company had set the goal to grow Lotte Biologics into one of the Top 10 global CDMO companies by investing ₩2.5 trillion over the next 10 years. The Bio USA is expected to be Lotte Biologics’s official debut in the global market. Lotte Biologics has secured an exclusive booth in the 'Contract Services Zone.’ Based on the manufacturing capability secured with the BMS plant, the company plans to make its name known to pharma and bio companies around the world at the event. Locations of Korean companies/organizations at BIo USA this year SK Pharmteco plans to participate in the event Yposkesi that it acquired last year. The Korean investment firm SK Holdings acquired the French gene and cell therapy CMO Yposkesi in March last year. The financial terms of the deal were not disclosed under agreement by both parties. In June last year, the company had additionally invited €58 million (approx. ₩80 billion ) to build a second plant. The second plant is expected to be completed by 2023 at a 5,000㎡ scale. If completed, the company will own the largest manufacturing capacity in Europe at a 10,000㎡scale. SK had also acquired BMS’s Ireland Swords plant in 2017 and US AMPAC in 2018. In 2019, the company had then established SK Pharmteco as an integrated CMO corporation. Samsung Biologics and Celltrion, regulars at Bio USA had also secured exclusive booths at the event. As the first offline event to be held in three years, the two companies are known to have high expectations for the event. Samsung Biologics’ CEO John Rim is expected to personally attend the event. Samsung Biologics has been recognized for its CMO capability in the global market during the past two years in the prolonged COVID-19 crisis. Samsung Biologics had decided to operate its own booth at Bio USA. Pic: 2019 Bio USA Other bio companies have also shown high expectations for this year’s event. Vigencell plans to attend this year’s event to have partnering meetings with various global companies. During the conference, it had made plans to have meetings with various companies and promote its ▲ViMedier ™(VM), the world’s first cord blood-derived myeloid suppressor cell therapy, ▲ViRanger ™(VR), the “Off-the-Shelf” allogenic universal T cell gene therapy, and ▲ViTier ™(VT), an antigen-specific killer T cell therapy. Bridge Bio Therapeutics has received an opportunity to introduce its company face-to-face for 13 minutes in front of industry officials at the ‘Company Presentation Theater 3’ on the morning 16th (local time), the last day of the event. The company plans to introduce its main development projects such as its targeted therapy candidates in its anticancer pipeline, 'BBT-176', 'BBT-207,’ as well as its ulcerative colitis treatment candidate 'BBT-401,’ idiopathic pulmonary fibrosis treatment candidate ‘BBT-877.’ Korea Bio and KOTRA which are supporting this year’s event explained that global interest in Korean companies has increased compared to the past. An official from Korea Bio said, “We have been receiving continued requests for partnership with Korean companies. Some have specifically requested to meet with certain companies, and some have asked us for recommendations.” He added, “Overseas companies have been more actively making requests, especially on vaccines or treatments.”
- Company
- Pharmas succeed in additionally avoiding Entresto patent
- by Kim, Jin-Gu Jun 03, 2022 06:37am
- Domestic pharmaceutical companies have succeeded in additionally avoiding the patent of Novartis’s heart failure treatment ‘Entresto.’ According to industry sources on the 2nd, the Intellectual Property Trial and Appeal Board recently ruled that the claims were established in the trial to confirm the passive scope of rights on Entresto’s substance patent (10-1700062) that Hanmi Pharmaceuticals filed against Novartis. In May last year, 10 companies in addition to Hanmi Pharmaceutical – Chong Kun Dang, YooYoung Pharmaceutical, Hana Pharm, Hanlim Pharm, Ahn-Gook Pharmaceutical, Genuone Sciences, GenuPharma, Samjin Pharm, Yuyu Pharm, Elyson Pharm – filed the same claims on this patent that is set to expire in 2028. Among these, the decision on Hanmi Pharmaceutical’s trial was the first to be made, and the results of other companies are also expected to be released soon. The Intellectual Property Trial and Appeal Board had also ruled in favor of the generic companies in a trial to confirm the passive scope of rights filed on Entresto’s another substance patent(10-1589317) that is set to expire in 2029 that Hanmi Pharmaceutical and Daewoong Pharmaceuticals had filed. The 10 companies – Chong Kun Dang, YooYoung Pharmaceutical, Hana Pharm, Hanlim Pharm, Ahn-Gook Pharmaceutical, Genuone Sciences, GenuPharma, Samjin Pharm, Yuyu Pharm, and Elyson Pharm – are also challenging the patent, results of which are expected to come out soon. Generic companies have also succeeded in avoiding Entresto’s crystalline patent. At the time, 13 domestic companies including Hanmi Pharmaceuticals and Chong Kun Dang succeeded in avoiding this patent that is set to expire in 2027. Currently, the issue is being tried at the Patent Court of Korea after Novartis’ appeal. Entresto is protected with a total of 5 (including 1 non-listed) patents. The patents are ▲salt and hydrates patent that expires in November 2026, ▲use patent that expires in July 2027, ▲crystalline patent set to expire in September 2027, ▲composition patent set to expire in November 2028, and another ▲composition patent set to expire in January 2029. Among the 5 patents, generic companies have now overcome 3 patents, the ▲crystalline patent set to expire in September 2027, ▲the composition patent set to expire in November 2028, and another ▲composition patent set to expire in January 2029. Only two patents, ▲the salt and hydrates patent that expires in November 2026 and the ▲use patent that expires in July 2027 are now left to be challenged. If the generic companies succeed in overcoming the remaining patents, they will qualify for early generic release. Entresto's PMS already expired in April. The key is likely to be the use patent that is set to expire in July 2027. Entresto is a combination drug of valsartan and sacubitril and has no separate substance patent. Therefore, the two patents on the ingredients act as substance patents. Entresto is Novartis’ heart failure treatment that was launched in October 2017 in Korea. According to the market research institution UBIST, outpatient prescription sales of Entresto have been rapidly increasing in size after recording ₩6.3 billion in 2018. Its sales recorded ₩32.3 billion last year.
- Company
- 10 years since stem cell therapy was introduced
- by Chon, Seung-Hyun Jun 03, 2022 06:36am
- 4 types of domestic approved stem cell therapyTen years have passed since stem cell treatments appeared in Korea, but they have yet to produce commercial results. Medipost's CARTISTEM is recording annual sales of 10 billion won in Korea, but there is virtually no overseas sales. According to the Financial Supervisory Service on the 2nd, Medipost's sales of stem cell treatments in the first quarter were 4.5 billion won, up 3.5% from a year earlier. Medipost's stem cell therapy is the only treatment for osteoarthritis, CARTISTEM. CARTISTEM is a drug mainly composed of stem cells derived from cord blood of the same kind. Medipost succeeded in developing the world's first cord blood-derived stem cell therapy using cord blood stem cells from others, and received an item approval from the MFDS in January 2012. It is used for the treatment of knee cartilage defects in ICRS grade IV. After surpassing 10 billion won in sales for the first time in 2017, CARTISTEM posted 10 billion won in sales for five consecutive years until last year. Last year, CARTISTEM's sales reached 17.2 billion won. However, the recent growth has slowed down somewhat. CARTISTEM's sales grew 36.1% and 16.6% year-on-year in 2018 and 2019, respectively, but in 2020 and 2021, they increased only 3.2% and 3.8% year-on-year, respectively. Looking at sales in the first quarter, CARTISTEM increased 95.1% and 40.1% year-on-year in the first quarter of 2018 and 2019. However, CARTISTEM's sales in the first quarter of 2020 and 2021 grew less than 1% year-on-year and recorded 3% growth this year. Medipost is seeking to enter the global market of CARTISTEM, but no overseas sales have occurred yet. The sales performance of other stem cell treatments other than CARTISTEM is even lower than expected. Currently, there are a total of four types of stem cell treatments approved in Korea. After Pharmicell's acute myocardial infarction treatment Hearticellgram-AMI was approved in Korea as the world's first stem cell treatment in 2011, CARTISTEM and Antrogen's Crohnistem were approved for market in 2012, and CORESTEM's Lou Gehrig's fourth stem cell treatment in 2014. In the first quarter of last year, Pharmicell's bio business sales were only 572 million won. Pharmicell's bio business includes cosmetics along with Hearticellgram-AMI. Last year, Pharmicell's bio business sales were only 800 million won. Cupistem posted 700 million won in sales in 2020, including stem cell culture. It recorded 359 million won in sales in the first quarter of last year. Antrogen has not disclosed sales by business units since the second quarter of last year. Total sales of anthrogen in the first quarter were 1.7 billion won. CORESTEM's Neuronata recorded sales of 1.9 billion won and 1.2 billion won, respectively, in 2020 and last year. It made 300 million won in sales in the first quarter. Although it received great attention at the time of domestic approval, it is not in high demand due to the characteristics of rare diseases, and its preference is rarely increasing at the prescription site. Stem cell therapy was once in the spotlight as a next-generation growth engine, but news of the recent emergence of new products is also far from clear. Since Neuronata's approval in 2014, there are no stem cell treatments approved for eight years. In 2016, the Ministry of Food and Drug Safety revised the regulations for product licensing screening such as biological drugs, allowing cell therapy used for life-threatening diseases or severe irreversible diseases to receive conditional approval only with the results of phase 2 clinical trials. The intention is to shorten the time to enter the market for cell therapy products whose safety has been confirmed and treatment effects have been searched. A life-threatening disease is a disease that is likely to die if it is not accompanied by appropriate treatment and is defined as a disease in which there is no alternative to treatment. Serious irreversible disease refers to a disease or condition in which irreversible pathological conditions deteriorate for functions necessary for daily life if appropriate treatment is not accompanied. After easing regulations on cell therapy approval, bio companies such as Kang Stem Biotech, Naturecell, and Pharmicell attempted conditional approval of stem cell treatments, but all failed.
- Company
- Dukarb of Huons won the patent battle
- by Kim, Jin-Gu Jun 03, 2022 06:36am
- Given that Boryung won a series of previous referees, the pharmaceutical industry is paying keen attention to the decision, which is the opposite of the previous one. ◆Patent judge decides opposite to previous judgment According to the pharmaceutical industry on the 2nd, the Korean Intellectual Property Tribunal made a claim citation decision on the 31st of last month in a passive judgment on the scope of rights for patent of Dukarb filed by Huons against Boryung. For generic companies, including Huons, they won the Dukarb patent dispute for the first time. The Dukarb patent dispute began in March last year when 40 pharmaceutical companies filed a series of passive judgment on the scope of rights, starting with Arlico. The first decision was made in March this year. Arlico, Shinpoog, HLB, and Union Korea, Futechs Pharmaceutical lost after receiving a decision to dismiss the claim. In April, Hana, Whan In Pharm, and Union Korea also lost. The pharmaceutical industry judged that the rest of generic companies are likely to lose in the first trial. This is because the Patent Tribunal tends to cite the preceding trial as it is for cases with the same content. ◆ Huons wins first trial by changing target to non-core dose product Dukarb consists of a total of four items depending on the content. There are 30/5 mg, 30/10 mg, 60/5 mg, and 60/10 mg doses. Among them, patent of Dukarb protects only 30/5mg. Boryung has registered a patent only for its core dose of 30/5mg among the four Dukarb products. The generic companies requested a passive scope of rights confirmation trial targeting the core capacity of 30/5mg. However, Huons changed the target to 60/5mg. In the case of 60/5mg, non-infringement is clear because it is not protected by patents in the first place. For this reason, the Patent Tribunal made a decision citing Huons' claim. ◆Despite the victory of the first trial, patent avoidance of core capacity products failed However, since this trial decision is not about 30/5mg products, Huons cannot release 30/5mg generics even if it wins the first trial. 30/5 mg-related generic for exclusivity cannot be obtained. An official from the pharmaceutical industry said, "Huons met the requirement of winning the first trial, but the core capacity has not been avoided." "For Boryung, we are still protecting the Dukarb patent like the previous judges." Dukarb is a combination product that combines Amlodipine with Fimasartan, a hypertension treatment developed by Boryung. Among Kanarb-based combinations, the prescription performance is the highest. According to UBIST, a pharmaceutical market research firm, the prescription amount was 41.1 billion won last year. It increased by 14% compared to 36.1 billion won in 2020.
- Company
- 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.
