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- 2026-03-14 00:31:33
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- the era of Lung cancer cure
- by Jung, Sae-Im Aug 14, 2023 05:21am
- The third-generation EGFR-targeting anti-cancer drug Tagrisso (Osimertinib) has left a unique record in non-small cell lung cancer. Significant improvement was achieved in adjuvant therapy after surgery, and it was also proven that survival time could be extended. This is an area that previous TKI drugs have failed to overcome. Tagrisso has already demonstrated that it can reduce the risk of recurrence or death by about 80% through the phase 3 clinical trial of ADUARA three years ago. Since then, people's attention has been focused on overall survival. I wondered how much longer actual patients could live if Tagrisso was used early. The results were revealed at ASCO 2023 held this year. As a result of analyzing the overall survival rate at 5 years, the risk of death in the Tagrisso group was 88%, compared to the placebo group (78%), and the risk of death was reduced by 51% (HR=0.49). The overall survival improvement of Tagrisso was consistently shown in the sub-analysis according to sex, age, race, smoking history, and adjuvant chemotherapy. Professor Han Ji-yeon, National Cancer Center.\ Han Ji-yeon, professor of hemato-oncology at the National Cancer Center, said, "Following the primary evaluation variable, DFS, OS improvement also showed data of HR of 0.49." It was groundbreaking in that it opened." The reason for administering adjuvant chemotherapy after surgery in early patients is to minimize the possibility of recurrence by preventing very small tumors from remaining in the early stage. However, the cytotoxic anticancer drugs used before Tagrisso were not very effective in reducing recurrence. According to Professor Han, cytotoxic anticancer drugs do not respond well to patients with EGFR-mutated lung cancer, so more than half suffer recurrence. With the introduction of Tagrisso, the recurrence rate of patients dropped significantly from 3% in the first year to 10% in the second year. At 3 years, 78% of patients still had no recurrence of cancer. Tagrisso ADAURA OS graph (source ASCO) According to the sub-analysis, the risk ratio was slightly higher in the L858R patient group than in the exon 19 deletion patient group among EGFR mutation types, at 0.68, but still proved the benefit of Tagrisso. Regarding this, Professor Han explained, "The receptor mutation structures of the exon 19 defect and L858R are different, but compared to the L858R mutation, the exon 19 defect has a structural feature that TKI adheres well." Professor Han explained, "Also, the L858R mutation rate was relatively higher in Asians, so the results were better in non-Asians. There is no way to solve the difference due to the characteristics of genetic mutations biologically." Following the DFS risk ratio of 0.17, the primary endpoint, the OS risk ratio of 0.49 was added, and Professor Han emphasized that Tagrisso's position in postoperative adjuvant therapy has become more solid. In addition, he emphasized the need to change the perception of reimbursement registration for adjuvant therapy. Earlier, in a discussion session on adjuvant treatment after Tagrisso surgery at ASCO, she said, "10% of patients who would not have survived 5 years without Tagrisso are alive." Then, an opinion was raised that “global support is needed to provide support for early screening and treatment so that the gap and inequality in global access to effective cancer treatment does not deepen.” In Korea, Tagrisso can still be used as a reimbursement only for the second or higher treatment only for progressive and metastatic cases, leaving a large gap with the global market. Professor Han said, “It has been about five years since Tagrisso was approved in Korea, but it is not yet covered by insurance as a first-line treatment. Considering the global trend, discussing first-line treatment benefits is too late.” If it goes well, I think that Tagrisso should be provided even in the environment of early lung cancer adjuvant therapy, which opened the 'era of lung cancer cure'," she emphasized.
- Company
- First immuno-oncology drug for endometrial cancer?
- by Eo, Yun-Ho Aug 14, 2023 05:21am
- Attention is rising on whether the first immuno-onoclogy treatment option will be approved for endometrial cancer in Korea. According to industry sources, GSK Korea’s PD-1 inhibitor Jemperli (dostarlimab) has passed review by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee and is soon to start drug pricing negotiations with the National Health Insurance Service. The reimbursement process for the drug has been progressing relatively quickly since its approval in December, and as the drug seeks to be listed for a different indication from existing drugs, whether it will derive positive results is a focus of interest. For the benefit of these patients, GSK has been offering an Expanded Access Program (EAP) in 15 major medical institutions in Korea since earlier this year before filing for reimbursement. Unlike other immuno-oncology drugs, Jemperli is the first drug indicated for the treatment of mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy regimen. This was why the company decided to first provide treatment opportunities to those patients in need. Jemperli’s approval was based on the cohort A1 analysis results of Phase I multicohort GARNET trial that included a cohort of patients with relapsed or advanced dMMR/MSI-H endometrial cancer who progressed on or following prior treatment with a platinum-containing regimen. In particular, this study had the largest cohort among PD-1 inhibitor monotherapy studies for dMMR/MSI-H endometrial cancer patients among those that have been conducted so far. The major efficacy outcome measures of the study were Objective Response Rate (ORR) and Duration Of Response (DOR) as determined by a Blinded Independent Central Review (BICR) according to (Response Evaluation Criteria Solid Tumors) RECIST v 1.1. As a result of analyzing a total of 108 patients with a median follow-up of 16.3 months, Jemperli demonstrated durable antitumor activity with a manageable safety profile. In the cohort, the ORR was 43.5% and the median DOR was not yet reached. Disease Control Rate (DCR) was 55.6%, and the proportions of responses lasting 6 and 12 months were 97.9% and 90.9%, respectively. Endometrial cancer develops in the endometrium, the inner lining of the uterus, and accounts for the majority of cervical cancer. Roughly, 1 out of 4 endometrial cancer patients are diagnosed to be in the advanced stage or experience recurrence, and patients whose disease recurs after platinum-based chemotherapy have limited treatment options.
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- With the BPH drug Duodart be the first combo to succeed?
- by Kim, Jin-Gu Aug 14, 2023 05:21am
- Pic of Duodart GSK’s benign prostatic hyperplasia (BPH) drug ‘Duodart (dutasteride+tamsulosin)’ has been making rapid growth in the outpatient prescription market in Korea. Until now, the market for combination drugs in the field of urology was considered barren. Unlike other chronic disease areas, combination drugs are rare in the area. Companies have been dropping the development of their combo drugs shortly before commercialization due to low marketability. This is why the industry is focused on the success of Duodart’s soft landing in the Korean market. If Duodart paves the way and makes success as a combination drug in the field of urology, the industry believes it will encourage the development of other combination drugs in the market. Duodart’s annual sales to rise to record KRW 10 billion in its second year of release According to the market research institution UBIST on the 11th, GSK’s Duodart posted outpatient prescriptions of KRW 3.9 billion in Q2 this year This is a 4.5 time rise from the KRW 0.9 billion the drug had made in Q2 last year. Duodart is a combination of dutasteride tamsulosin. Both ingredients are used to treat BPH. The company received approval for the drug in May 2021 and released the drug with reimbursement in March last year. Duodart’s sales had grown rapidly upon its release. Its sales rose from KRW 0.9 billion in Q2 last year to KRW 1.5 billion in Q3, then to KRW 2.8 billion in Q1 this year, and KRW 3.9 billion in Q2 this year. At this pace, its sales will likely exceed KRW 10 billion by the end of this year. ▲ Quarterly prescription of Duodart (Unit: KRW 0.1 bil, Source: UBIST) The pharmaceutical industry is keenly eying the success potential of Duodart because the market for combination drugs in urology was considered barren until now. Although the patent for BMH drugs such as tamsulosin, finasteride, dutasteride, OAB drugs such as mirabegron, solifenacin, and erectile dysfunction drugs sildenafil and tadalafil had expired until now, news of combination products being released that use these various off-patent ingredients are rare in Korea. Hamni Pharm’s tamsulosin+tadalafil combination drug ‘Gugutams’ i which was released in 2014, is virtually the only combination drug that is available in the market. However, Gugutams fell short of market expectations, as it has been posting annual sales that range around KRW 2 billion. The industry analysis is that the market has a strong loyalty for original drugs. Also, its total market size is small compared to those of hypertension, diabetes, or hyperlipidemia, and as nearly 100 generics are already available for each ingredient, the marketability of developing combination drugs is not high compared to the input cost. Duodart shows rapid growth...Will this spark the development of combo drugs in urology? This was why so many companies had discontinued their development of combination drugs in the field. Pic of Gugutams, the only urology combo drug available in the market Ildong Pharmaceutical, Yungjin Pharm, and Chong Kun Dang, which had started the development of their tamsulosin+tadalafil at the same time as Hanmi Pharm, had all discontinued the development of their respective combinations. Ildong Pharmaceutical had also jumped into the development of a tamsulosin+solifenacin combination for BPH but decided not to release the product just before commercialization. Ildong Pharmaceutical started Phase III trials for its combination drug in 2015 and completed the trial in 2019, but decided not to release the drug after internal discussions. Similarly, Jeil Pharmaceutical had started developing a combination drug with the same ingredients as Ildong but did not apply for marketing authorization for its drug even after completing the Phase III clinical trial in 2019. The industry interprets that the company had stopped development of the combination. However, attention is focused on whether the sales growth of Duodart will bring about change in this atmosphere as it hints at the possibility of success in the field of urology as a combination drug. Currently, there are four to five clinical trials in progress for combination drugs in urology. They are combination drugs for BPH+erectile dysfunction or combination drugs for BPH+OAB. DOngkook Pharmacuetical recently completed Phase III trials for its combination of dutasteride and tadalafil. Yuyu Pharma also started developing a combination drug with the same ingredients. Although the plan for its Phase III trials was approved in 2018, the need to change its formulation had been raised before its initiation, and the company decided to restart its development from Phase 1. Development of a combination drug that treats BPH and OAB at the same time is also in full swing. Kyungdong Pharm and DongKoo Bio&Pharma have started Phase III trials at about the same time and are competing to develop their combination drugs. DongKoo Bio&Pharma also received approval to initiate a Phase III clinical trial for its tamsulosin+mirabegron combination. Kyungdong Pharmaceutical received approval to initiate Phase III trials using the same combination 2 months later. In addition, CTCBio has completed its Phase III trial for its clomipramine+ sildenafil combination, as a treatment for premature ejaculation and erectile dysfunction at the same time, and is preparing to apply for its marketing approval in Korea.
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- Oral SMA drug Evrysdi prescribed at tertiary hospitals
- by Eo, Yun-Ho Aug 14, 2023 05:21am
- The oral spinal muscular atrophy (SMA) treatment ‘Evrysdi’ may now be prescribed at tertiary hospitals in Korea. According to industry sources, Roche Korea’s SMA treatment Evrysdi (risdiplam) passed the drug committee (DC) reviews at the Big 5 tertiary hospitals in Korea - Samsung Medical Center, Seoul National University Hospital, Seoul, Asan Medical Center, Seoul St.Mary’s Hospital, and Sinchon Severance Hospital – and many other major medical institutions including the Gangnam Severance Hospital, Pusan National University Hospital at Yangsan, and Yongin Severance Hospital. As Roche is currently in the final negotiation stage with the National Health Insurance Service for Evrysdi’s reimbursement, the industry believes Evrysdi’s reimbursement listing will quickly turn into prescriptions, if it is granted reimbursement. Evrysdi was first approved in Korea in November 2020. The company applied for the reimbursement listing of its drug in July 2022 but the agenda had long been pending at the Drug Reimbursement Standard Subcommittee stage after the committee deferred making decisions. The agenda finally passed the Drug Reimbursement Standard Committee review in June this year. Whether Evrysdi will be able to complete the reimbursement listing process until the end of this time and settle as an oral treatment option for SMA in Korea remains to be seen. As the first oral option introduced in the field of SMA, Evrysdi has the advantage of allowing customized prescriptions for patients according to age and weight. Currently, Biogen’s ‘Spinraza (nusinersen)’ and Novartis's Zolgensma (onasemnogene abeparvovec-xioi) are listed for reimbursement in Korea. Meanwhile, Evrysdi’s efficacy has been demonstrated through the FIREFISH trial that was conducted on infants 2 months to 7 months of age, and the SUNFISH trial that was conducted on children and adults of 2 years to 25 years of age. In the SUNFISH trial that was conducted on 180 Type 2 or 3 SMA patients, Evrysdi improved motor function at Month 12, as measured by the Motor Function Measure 32 (MFM-32) score from baseline. Also, in the FIREFISH trial that was conducted on infants 2 to 7 months of age with Type 1 SMA, 88% of the patients that were administered Evrysdi for 2 years survived the 2 consecutive years without ventilator support. Based on the Bailey Infant Development Test (BSID-III) that measures infant development and motor activity, 59% of the infants that were administered Evrysdi were able to sit without support for at least 5 seconds. Also, 65% of the infants were able to control their necks for 1 year, 29% were able to turn on their buttocks, and 30% were able to stand with support.
- Company
- Could Lilly Retatrutide be a game-changer for obesity drug?
- by Nho, Byung Chul Aug 14, 2023 05:21am
- Attention is focusing on whether Eli Lilly can commercialize another blockbuster drug in the global obesity drug market worth 13 trillion won by entering phase 3 clinical trials for new drug candidates, Orforglipron and Retatrutide. According to related industries, the Ministry of Food and Drug Safety approved the phase 3 clinical trial to confirm the effect of once-weekly administration of Retatrutide in obese or overweight type 2 diabetes subjects in mid-March last month. Orforglipron also recently announced the results of its phase 2 clinical trial through the American Diabetes Association and is preparing for a global phase 3 clinical trial. Both candidates are a class of glucagon-like peptide-1 (GLP-1) receptor agonists that mimic hormones produced in the gut lining, which slow down digestion and act on receptors in the brain to reduce appetite and thus promote weight loss. is a mechanism that shows Retatrutide showed a weight loss effect of 24.2% after 48 weeks in the 12mg group, the highest dose, in a phase 2 clinical trial conducted on 281 diabetic patients aged 18 to 75 years. Orforglipron showed a practical pharmacological effect on weight management in phase 2 clinical trials and is expected to be released at a lower price compared to existing treatments because it is easy to produce as a non-peptide oral tablet. Two of the existing obesity treatment drugs contain Semaglutide and Tirzepatide, which are sold under the product names of Novo Nordisk Wegovy and Lily Mounjaro, respectively. According to the announcement of the American Diabetes Association, orforglipron·retatrutide has advantages over Wegovy and Mounjaro, such as high weight loss effect, low price, and ease of administration. Obesity drugs containing Semaglutide and Tirzepatide are effective in reducing body weight and blood sugar and alleviating high blood pressure but have the disadvantage of requiring weekly injections, being difficult to manufacture, and having high production costs because they are in the form of peptides. Novo Nordisk plans to develop an oral treatment for GLP-1 series Wegovy within the year and obtain US and European approval and is expected to compete with Retatrutide. This triple agonist simultaneously activates GLP-1, GIP, and glucagon receptors. GLP-1 promotes insulin secretion to lower blood sugar, suppress appetite, and reduce the rate of food excretion from the stomach and is used as a treatment for diabetes and obesity. Lilly's GLP-1 GIP dual agonist Mounjaro confirmed a 22.5% reduction effect when administered at the highest dose of 15 mg/0.5 ml for 72 weeks in obese patients without diabetes. It is approved only as an adjunct to diet and exercise therapy.
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- Imbruvica passed the drug reimbursement evaluation committee
- by Eo, Yun-Ho Aug 11, 2023 05:36am
- Imbruvica, a blood cancer treatment, has made progress in discussing the expansion of insurance benefits about a year after passing the cancer disease review committee. According to the related industry, Imbruvica's first-line indication for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) passed the HIRA drug reimbursement evaluation committee on the 3rd. Imbruvica's primary therapy indication was presented to the review committee three times from October 2021 to June 2022, but it did not pass. After that, it passed the review committee in September of last year and passed after being presented to the drug evaluation committee in August 2023. In the meantime, there have been many opinions about the need to expand benefits in the medical field. The HIRA is also judged to have no problem in terms of clinical usefulness, so it is considered that an appropriate financial sharing plan was presented at this Drug Evaluation Committee. Imbruvica demonstrated a survival benefit in CLL patients as a first-line monotherapy in the phase 3 studies 'RESONATETM' and 'RESONATETM-2'. These phase 3 clinical trials were the results of research sponsored by the NCI under the NIH, and 354 patients with an average age of less than 70 years and no prior anticancer treatment experience were enrolled in the clinical trials. As a result of the 48-month follow-up, 73% of the Imbruvica combination patient group continued Imbruvica treatment for 43 months. In particular, in the Imbruvica combination group, the risk related to PFS was reduced by 61% compared to current chemotherapy, and the risk in OS benefit was significantly reduced by 66%. Imbruvica is an oral BTK inhibitor developed for the first time and taken once a day. In Korea, it has been used in most secondary treatments for relapsed/refractory chronic lymphocytic leukemia since it was registered as a benefit in April 2018. It can be used as monotherapy, in combination therapy with obinutuzumab in previously untreated chronic lymphocytic leukemia patients younger than 65 years of age with comorbidities or at high risk.
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- Will Darzalex be reimb as 2nd-line treatment for MM?
- by Eo, Yun-Ho Aug 11, 2023 05:35am
- Whether progress will be made on the discussions on extending reimbursement of the multiple myeloma treatment ‘Darzalex’ as second-line treatment is gaining attention. According to industry sources, Janssen Korea is reattempting to apply for reimbursement of its 'Darzalex (daratumumab)' to be reviewed by the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee. The company had succeeded in setting reimbursement standards for Dazarlex as first-line therapy for multiple myeloma in combination with Velcade® + thalidomide + dexamethasone (DVTd), and the agenda is awaiting deliberation by the Drug Reimbursement Review Committee (DREC) soon. However, the drug failed to receive reimbursement standards as second-line therapy at the DREC level in March for its DRd (daratumumab+lenalidomide+dexamethasone), DVd(daratumumab+bortezomib+dexamethasone), and DKd (daratumumab+carfilzomib+dexamethasone) indications. Therefore, whether the company will succeed in extending the much-needed Darzalex’s reimbursement to the second line this time remains a focus of attention. The NCCN and ESMO guidelines recommend Darzalex as part of standard first- and second-line combination therapy for multiple myeloma and as part of the first-line DVTd therapy in patients who are eligible for autologous stem cell transplant. Darzalex is a human monoclonal antibody that targets CD38, a cell surface protein that is overexpressed on multiple myeloma (MM) cells. The drug induces direct celluar apoptosis via ▲ complement-dependent cytotoxicity (CDC), ▲ antibody-dependent cell-mediated cytotoxicity (ADCC), ▲ and antibody-dependent cellular phagocytosis (ADCP) triggered complement-dependent cytotoxicity (CDC).
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- Lotte Biologics advances CDMO Biz with Roche Diagnostics
- by Jung, Sae-Im Aug 10, 2023 05:33am
- On the 9th, Lotte Biologics announced that it had recently signed a Memorandum of Understanding (MOU) with Roche Diagnostics, the diagnostic division of the Roche Group, to advance the productivity and quality of its Contract Development and Manufacturing Organization (CDMO) business. The MOU, which was signed at Penzberg, where Roche Diagnostics Custom Biotech Center is located, aims to enhance the productivity and quality of Lotte Biologics’ pharmaceutical production. Won-jik Lee, CEO of Lotte Biologics, Rainer Mueller, Vice President of Roche Diagnostics Custom Biotech, and Kit Tang, General Manager of Roche Diagnostics Korea, attended the signing ceremony. Under the agreement, the two companies will collaborate in various areas, including the establishment of hardware and automation systems for the production process design of Lotte Biologics’ Mega Plant, as well as technical consulting and equipment support. The companies also plan to prepare a training program for the smooth operation of the ‘Bio-Venture Initiative’ that will be established in the Mega Plan Complex to support the preparation of a forum for technology development cooperation between bioventure companies. Won-jik Lee, CEO of Lotte Biologics, said, “Through the MOU, we plan to reinforce the production process capability of our company’s Mega Plant with Roche Diagnostics. Also, we hope that our collaboration with the global in-vitro leader Roche Diagnostics will create synergy and facilitate smooth operation of our Mega Plant, thereby improving the efficiency of our business while fulfilling customer needs."
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- Generic drugs occupy over 70% of tamsulosin market
- by Kim, Jin-Gu Aug 10, 2023 05:33am
- The share of generic drugs in the market for prostatic hyperplasia treatments that contain tamsulosin exceeded 70%. This is interpreted as an effect of the rapid rise in generic sales while the prescription performance of original products slowed down. One variable in this market is impurities. At the end of June, impurities were detected in some products, initiating voluntary recalls. However, as only one product made the voluntary recall, its impact on the overall market is not significant yet. Prescription of tamsulosin generics rise 18% in one year... market share exceeds 70% According to the market research institute UBIST on the 9th, the outpatient prescription market for tamsulosin single-agent prostatic hyperplasia treatments in 1H recorded KRW 107.2 billion. The market increased by 10% from KRW 97 billion in 1H last year. The growth of generic products in the market led to the expansion of the overall market size. In 1H this year, the combined prescriptions for tamsulosin generics amounted to KRW 74.9 billion, an 18% increase from the past year. On the other hand, prescriptions of the original product Harnal-D decreased by 3% from KRW 33.4 billion in 1H last year to become KRW 32.3 billion in 1H this year. Prescription Performance of Tamsulosin Drugs for BPH While sales of the original drug slowed down, sales of generics rose rapidly. As a result, the share of generics in this market exceeded 70% for the first time. The quarterly share of generics exceeded 50% in Q3 2018 and then expanded further to exceed 60% in Q2 2021. Then, in the second quarter of this year, it exceeded 70%. The share of generics in the market reached 70.2% in Q2 this year. Sales of Hanmi Tams·Taminal·Bearosin rise over 10%…sales of combo drug Duodart rise rapidly Prescription performance of most of the major generic products increased by more than 10% during the past year. Hanmi Pharm’s 'Hanmi Tams' and 'Hanmi Tams OD’ recorded the highest prescription performance among generic tamsulosin drugs in 1H this year. The combined prescription of the two products in 1H this year recorded KRW 19.2 billion, up 11% from the KRW 17.3 billion the two drugs had made in 1H last year. In particular, prescriptions of Hanmi Tams OD rose from KRW 4.6 billion to KRW 6.2 billion in one year, driving the growth of the entire product line. Hanmi Tams OD is an orally disintegrating tablet version of Hanmi Tams, which is a capsule formulation. In addition, the prescription performance of all products with half-year prescriptions that exceed KRW 2 billion increased by more than 10%. Sales of Genuone Science's 'Taminal' increased by 11% from KRW 3.7 billion to KRW 4.1 billion, and Daewoong Bio's 'Bearosin' increased by 25% from KRW 2.8 billion to KRW 3.5 billion. Prescriptions of DongKoo Bio&Pharma’s ‘Uropa,’ Celltrion Pharm’s ‘Tamsol (30%↑)', Kyung Dong Pharma’s ' Uronal (14%↑)', Dongkook Pharmaceutical’s ' Tarunal (26%↑)', Huons’s ' Tamlusindi (19%↑)' had also increased relatively greatly. One product that stands out is GSK’s ‘Duodart.’ Duodart is a combination of tamsulosin and another prostatic hyperplasia drug dutasteride. Prescriptions of Duodart had only reached KRW 0.9 billion in 1H last year, but sales had risen by more than 7 times in one year to KRW 6.7 billion. GSK released the product in Q1 last year. The variable that remains in the market is impurities. Last June, Huons voluntarily recalled some lot numbers of its Tamlusindi. This was a voluntary recall made to address concerns related to the detection of excess N-nitroso tamsulosin impurities. However, the voluntary recall was limited to Huons. No cases of voluntary recall have been reported since then. In the current situation, the impact of the impurity issue is not expected to be significant. Specifically, how much the impurities will affect the overall tamsulosin market may be revealed at the end of this year.
- Company
- Patent dispute over Entresto's patents continue
- by Kim, Jin-Gu Aug 10, 2023 05:33am
- Pic of Entresto The patent dispute over ‘Entresto (sacubitril/valsartan),’ a chronic heart failure treatment with an annual prescription of more than KRW 40 billion, has been ongoing for over 2 years now. Novartis, the company that owns the original drug, is actively pursuing a defense strategy against generic companies' patent challenges. Novartis appealed after losing the 1st trial, and three cases are being tried in the second trial. Some of the results are expected to be pronounced next month. According to industry sources on the 8th, Novartis filed a trial revocation litigation against Hanmi Pharm and Elyson Pharm regarding Entresto’s salt·hydrate patent (10-1549318). After losing to generic companies in the Intellectual Property Trial and Appeal Board (1st trial), the company filed an appeal to the Patent Court of Korea against the ruling. Due to Novartis' appeal, the number of patent disputes in the second trial increased to 3. In addition to the salt and hydrate patents, Novartis and generic companies are in dispute in the Patent Court of Korea the crystalline form patent (10-1432821) and composition/use patent (10-0984939) of Entresto. Entresto is protected by 6 patents: ▲salt and hydrate 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 (10-1700062), ▲another composition patent set to expire in January 2029 (10-1589317), and ▲a use patent set to expire in 2033 (10-2159601). Among the 6 patents, generic companies have succeeded in nullifying or avoiding 2 patents. The results of the two were finalized after the generic companies won the first trial and Novartis did not file an appeal. In the case of the use patent that expires in 2033, the patent was listed after generic companies applied for marketing authorization of their generics. The generic companies have also succeeded in winning against Novartis in the first trial for the other 3 patents as well. However, Novartis chose to appeal and proceed to the Patent Court of Korea for all 3 cases. The Patent Court of Korea announced that it will make a ruling on the crystalline patent on the 14th of next month. This means that the outline of the second trial rulings regarding the Entresto patent dispute will be revealed next month. After this ruling, the other 2 rulings are expected to be made until next year. If the party that loses the 2nd trial decides to go on to the Supreme Court, the Entresto patent dispute is likely to be prolonged to more than 4 years. Since 2021, generic companies have been filing trials against Entresto's patents. Starting with Elyson Pharm, about 10 companies including Hanmi Pharm, Chong Kun Dang, and Daewoong Pharmaceutical jumped into the dispute. Meanwhile, according to the market research institute UBIST, Entresto's outpatient prescriptions amounted to KRW 42.5 billion last year. Entresto has shown rapid growth in the market, increasing prescription sales by nearly KRW 10 billion every year. Its prescription performance, which recorded KRW 5.5 billion in 2018, increased to KRW 14.3 billion in 2019, KRW 22.4 billion in 2020, then to KRW 32.4 billion in 2021.
