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- 2026-04-07 13:28:20
- Company
- 'Dupixent,' the final stages of reimb expansion for children
- by Eo, Yun-Ho Jun 03, 2024 05:48am
- Sanofi Korea’s Dupixent (dupilumab) Dupixent is about to enter the last hurdle of expanding insurance reimbursement coverage for young children. According to industry sources, the Ministry of Health and Welfare (MOHW) has recently ordered drug pricing negotiations for Sanofi Korea’s Dupixent (dupilumab). Consequently, a tug-of-war between the government and Sanofi is about to start. Dupixent is covered by reimbursement for severe atomic dermatitis over the age of 6 years. If it completes the drug pricing negotiations and secures expanded reimbursement, prescriptions will become available to infants six months and above. This indication was approved in South Korea in November 2022. There have been talks about the unmet needs of Dupixent’s reimbursement expansion toward young children. Notably, the Severe Atopic Dermatitis Association (SADA) issued a statement urging the coverage of Dupixent for young children aged 6 months to younger than 6 years with severe atopic dermatitis. 85-90% of atopic dermatitis manifests symptoms at the age of five, and for severe cases, the disease persists until adulthood and relapses. However, treatments approved for children under the age of five are limited to topical treatments, and the patients with symptoms uncontrolled with topical treatments have limited treatment options due to long-term skin retractions and infection risks. Meanwhile, Dupixent demonstrated its efficacy towards young children through the LIBERTY AD PRESCHOOL Phase 3 trial. This study evaluated the efficacy and safety of Dupixent in patients aged 6 months to younger than 6 years with atopic dermatitis who have inadequate responses to topical treatment. At 16 weeks, 28% of patients treated with Dupixent in combination with topical corticosteroids (TCS) showed a score of 0 or 1 point in the Investigator's Global Assessment PN-Stage (IGA PN-S), demonstrating a significant improvement in atopic dermatitis compared to 4% of the placebo group. Consequently, it met the primary efficacy endpoint. Furthermore, 53% of patients accomplished EASI-75, the secondary endpoint, in the Dupixent plus TCS combination therapy group, significantly higher than the 11% in the placebo group. Dupixent plus TCS combination therapy also improved the WSI-NRS (Worst Scratch and Itch Numerical Rating Scale) score by 49.4% compared to the placebo group’s 2.2%, demonstrating significant improvements in the common symptom of itchiness in atopic dermatitis.
- Company
- Thrombocytopenia treatment market rises as blue ocean
- by Nho, Byung Chul Jun 03, 2024 05:48am
- The prescription market for idiopathic (immune) thrombocytopenia treatments is expected to grow exponentially with the recent reimbursement standard extension granted in Korea. Until now, reimbursement for oral immune thrombocytopenia drugs has been limited to patients with immune thrombocytopenia who are refractory to corticosteroids and immunoglobulins after splenectomy or are refractory to corticosteroids and immunoglobulins and have medical contraindications to splenectomy. However, as of next month, the current reimbursement standards that require 'splenectomy' will be changed, and the oral drug will be available for use upon just the diagnosis of the disease, which is expected to expand the prescription market. Currently, Novartis' Revolade Tab (eltrombopag olamine) and Kyowa Kirin’s Romiplate (romiplostim) lead the market. The total market for both oral and injectable drugs is about KRW 15 billion based on last year's drug distribution results, and both treatments have been recording an upward-sloping sales curve. Revolade’s sales in 2020·2021·2022·2023·2024 1Q had been KRW7.5 billion·KRW 7.9 billion·KRW8.5 billion·KRW 9 billion·KRW 2.2 billion, respectively. Romiplate’s sales had remained in the KRW 1.3 billion to KRW 2 billion band from 2020-2021-2022, then grew 150% in 2023 to surpass KRW 5 billion. In 1Q 2024, its sales reached KRW 1.6 billion, closely following the performance of Revolade, which reached KRW 2.2 billion. In addition, JW Pharmaceuticals and Handok Pharmaceuticals are expected to receive approval for their Tavalisse (fostamatinib) and Doptelet (avatrombopag), which are new oral treatments for idiopathic (immune) thrombocytopenia in the third quarter of this year, further expanding treatment options. Immune thrombocytopenia is an autoimmune disease in which the body's immune system attacks platelets as foreign antigens. Serious bleeding has been reported in 9.5% of affected adults, and the patients are at 1.3 to 2.2 times higher risk of death due to cardiovascular events, infectious diseases, and serious bleeding than the general population. Also, at least half of the patients experienced fatigue and decreased mental, emotional, and physical health, as well as reduced quality of social functioning. The disease can affect many aspects of the lives of patients and their families, rendering school, work, relationships, and sometimes even daily life difficult.
- Company
- Growing DME market…new drugs clinical trials·biosimilars
- by Son, Hyung-Min May 31, 2024 05:52am
- Korean pharmaceutical companies are challenging the market for diabetic macular edema treatments with oral formulations. Handok and Curacle confirmed effects in clinical trials for oral diabetic macular edema treatments. Because only injectables are available in the market, oral formulations can have a competitive edge because of their convenience of administration. Furthermore, Korean pharmaceutical companies are set to compete in the market with biosimilars to Eyelia. According to industry sources on May 29th, positive results were secured from novel candidate product RZ402’s Phase 2 trials for diabetic macular edema conducted by Rezolute, Handok’s related company. This novel candidate drug works by inhibiting the overexpression of plasma kallikrein, which participates in blood coagulation. Handok owns RZ402’s marketing rights in South Korea. Diabetic macular edema (DME) is a diabetes complication that affects the central area of the retina, leading to vision deterioration and disorder. DME is a disease with damaged retinal vasculature due to increased blood glucose levels, resulting in macular fluid leaking. Conventional DME treatments are vascular endothelial growth factor (VEGFR) inhibitors, including Eylea, Lucentis, Beovu, and Vabysmo. Treatments offering the convenience of administrarion are leading the market. The intervals of administration of Eylea, the top-selling drug in the market, have been extended from once every two months to up to five months, and that of Vabysmo, an emerging competitor, can be administered once every four months. RZ402 is being developed as an oral formulation, and therefore, it has the advantage of differentiating from other treatments. This novel candidate product secured positive results from recently disclosed phase 2a trials, increasing its potential for commercialization. This research evaluated the efficacy and safety of RZ402 monotherapy (50 mg, 200 mg, 400 mg) and enrolled 94 patients with DME patients who had no prior experience with injectables or had limited therapies. The clinical results demonstrated that the RZ404 200 mg treatment group had the most improved edema, while there was no change across dosages. For the safety profile, no significant adverse reactions compared to the placebo were observed. Since the AZ402 200 mg treatment group had the most significant effect, this dosage will serve as the reference for future clinical 2b trials. Curacle, a Korea-based bioventure company, is developing an oral DME treatment CU06. The top-line results of clinical Phase 2a trials demonstrated no significant changes regarding the central subfield thickness, measured as CU06’s primary endpoint. However, significant improvements were observed in baseline in best-corrected visual acuity (BCVA), which was the secondary endpoint. In clinical trials, CU06 improved the patients’ word reading assessments within three months of administration. At 12 weeks, CU06 100, 200, and 300mg administration improved BCVA by up to 1.9, 2.5, and 2.2 letters, respectively. Notably, 300 mg treatment in the vision below 0.5 patient group improved BCVA by up to 6.6 letters at 16 weeks. Curacle signed a technology transfer licensing of CU06, excluding Asia, with Théa Open Innovation in October 2021. However, the company recently was notified of the return. Despite having the license returned, Curacle plans to continue the follow-up development since CU06 demonstrated clinical potential. Biosimilars are expected to be released…competition intensifies A significant number of Eyelia biosimilars are expected to be released. A significant number of Eyelia biosimilars are expected to be released in addition to novel oral formulations. Consequently, the competition in the market for DME is expected to intensify. Samsung Bioepis and Samil Pharmaceutical launched Afilivu, an Eyelia biosimilar, in the Korean market earlier this month. Afilivu was approved in February and completed reimbursement listing last month. In addition to these two companies, Sam Chun Dang Pharm successfully developed an Eyelia biosimilar, and Celltrion and Alteogen are also conducting clinical trials. Roche’s novel drug Vabysmo has been covered by insurance since last October and launched in the market. Vabysmo inhibits VEGF and inhibits angiopoietin-2 (Ang-2) to recover vasculature stabilization. It has the advantage of an extended effect. Vabysmo can be administered once every four months. Vabysmo’s global market sales closely match Eyelia’s. In two years of its launch, Vabysmo generated KRW 3.56 trillion in sales in the global market last year, which is over half of Eyelia’s KRW 7.8 trillion. Bayer, Eyelia’s developer, also recently introduced a high-dose formulation to defend the market. Bayer launched a product four times higher in dose than the previous 2 mg and extended the injection interval up to once every five months. Since Novartis’ Lucentis, Beovu, and Lucentis biosimilar are also seeking opportunities to expand sales, the competition in the market is expected to intensify.
- Company
- Adtralza becomes the 2nd reimbursed biological drug for AD
- by Son, Hyung-Min May 31, 2024 05:52am
- Jiyoung Ahn, Professor of Dermatology at the National Medical Center LEO Pharma Korea has launched Adtralza (tralokinumab) as the 2nd biologic drug in the atopic dermatitis market and is on its way to take on Dupixent. LEO Pharma has been emphasizing that Adtralza has a longer dosing interval after 16 weeks compared to existing therapies and is relatively cheaper, reducing the cost burden for patients. On March 30, LEO Pharma held a press conference at the Grand Hyatt Hotel in Seoul to celebrate the reimbursed launch of Adtralza. Adtralza is a biological drug that selectively targets interleukin-13 (IL-13). The drug is being reimbursed for the treatment of chronic severe atopic dermatitis in adults and adolescents from the 1st of this month. IL-13 is a key cytokine that causes signs and symptoms of atopic dermatitis, including immune dysregulation and skin barrier dysfunction, and is overexpressed in affected skin and is known to be correlated with the severity of the disease. The launch of Adtralza adds a biologic treatment option for atopic dermatitis alongside Sanofi's Dupixent, which inhibits IL-4 and IL-13. Adtralza is reimbursable for the treatment of chronic severe atopic dermatitis in adults (18 years and older) and adolescent patients (12 years to 17 years of age) whose condition has remained symptomatic for at least 3 years and meets one of the following conditions: ▲patient received at least 4 weeks of topical therapy (at least moderate-potency corticosteroids or calcineurin inhibitors) as a first-line treatment but was unable to adequately control their condition, followed by at least 3 months of systemic immunosuppressive agents (cyclosporine or methotrexate) that did not result in a 50% or greater reduction in Eczema Area and Severity Index (EASI) or was unable to continue their use due to side effects’ or ▲Patients has an EASI of 23 or greater prior to Adtralza use. Adtralza’s clinical efficacy and safety were confirmed through four Phase III ECZTRA 3 and ECZTEND trials. The ECZTRA 3 trial compared Adtralza to placebo in patients 18 years of age and older with moderate-to-severe atopic dermatitis who had not responded adequately to prior topical therapy or requires systemic therapy. The primary endpoint of the trial was the Investigators' Global assessment score of 0 (clear) or 1 (almost clear) and EASI 75 (75% improvement in Eczema Area and Severity Index)at week 16. Trial results showed that the rate of patients who achieved EASI 75 at Week 16 was 56.0% in the Adtralza group, which is a clinically significant improvement compared with the 35.7% in the placebo group. Also, 38.9% in the Adtralza group achieved IGA (Investigator’s Global Assessment) 0/1 at week 16, compared with 26.2% in the placebo group. Results from the ECZTEND study, which evaluated the long-term efficacy of Adtralza, showed that 84.5% of patients had an EASI-75 at 4 years of Adtralza treatment. Adtralza was also effective in patients with difficult-to-treat head and neck atopic dermatitis. In particular, Adtralza had the advantage of being dosed once every 4 weeks after week 16, ensuring ease of administration for the patients. Jiyoung Ahn, Professor of Dermatology at the National Medical Center, said, “Although the symptoms of atopic dermatitis may not seem serious, the itching and pain that patients experience can interfere with sleep and other daily life activities. Although there are many treatment options available on the market, the number of patients with atopic flare-ups continues to increase, so various treatment options are necessary, We are excited about the increased treatment options that the launch of Adtralza brings to us healthcare providers and patients." Dong Hun Lee, Professor of Dermatology at Seoul National University Hospital, said, “Adtralza is convenient because it can be administered every 4 weeks at the discretion of the physician for patients with clear or nearly clear skin after 16 weeks of treatment. Also, its reimbursed price is lower than its competitors, which will reduce the financial burden borne by the patients."
- Policy
- Qarziba’s reimb standard has been set before approval
- by Lee, Tak-Sun May 31, 2024 05:51am
- The reimbursement standard has been set for Qarziba (dinutuximab, Recordati Korea), which was designated as the 1st drug for a “Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations,” even though it has not yet received approval from the Ministry of Food and Drug Safety (MFDS). Qarziba is used for treating neuroblastoma in young children over 12 months. The Health Insurance Review and Assessment Service (HIRA) held the 4th Cancer Disease Review Committee (CDRC) meeting 2024 on May 29 and announced this review result. Qarziba was considered for a review as a novel drug. It has been assigned to a “Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations.” The process for product approvals, reimbursement coverage reviews, and drug price negotiations are being conducted concurrently. The MFDS has completed the safety and efficacy review and is currently processing the product approval. Even though the drug has not yet received product approval, a reimbursement standard has been set because it was designated as part of a pilot project. The CDRC set the reimbursement standard for this drug for young children over 12 months with ▲ A high-risk neuroblastoma who had received bone marrrow removal therapy and a stem cell transplantation therapy after showing partial adverse reactions following chemostheray ▲Recurrent and refractory neuroblastma. The CDRC review results for Qarziba, nexatin inj plus Loicosodium inj plus FU inj Choongwae, nexatin inj plus Xeloda tab, and Trisenox Inj plus Vesanoid Soft Cap. At the meeting, CDRC also approved a reimbursement expansion proposal for nexatin inj plus Loicosodium inj plus FU inj Choongwae or nexatin inj plus Xeloda tab. Additionally, the CDRC passed a reimbursement expansion proposal for Trisenox Inj plus Vesanoid Soft Cap. The committee also considered opinions by the Korean Academy of Medical Sciences and drafted a reimbursement standard improvement proposal reflecting current clinical settings. The reimbursement standards have been set for anticancer therapies for treating gynecologic cancer (2 items), breast cancer (1 item), esophageal cancer (1 item), and urological cancer (2 items). The HIRA stated that it has considered the opinions of the Korean Medical Association and the Korean Academy of Medical Sciences regarding reimbursement standards and is proactively pursuing a review to improve pharmaceuticals, activities, and treatment materials through communication with the medical industry and academics. For anticancer therapy, the CDRC’s task force team reviewed 6 items. As a result, reimbursement standards have been set for anticancer therapies for treating gynecologic cancer (2 items), breast cancer (1 item), esophageal cancer (1 item), and urological cancer (2 items). The CDRC delivered partial approval of Lutathera inj use coverage, limiting to application by clinics. Additionally, the CDRC approved reimbursement for the use of Lutathera inj use, limited to application by clinics, exceeding the standard approval.
- Policy
- MFDS approves the orphan drug 'Pluvicto' for prostate cancer
- by Lee, Hye-Kyung May 31, 2024 05:51am
- The Ministry of Food and Drug Safety (MFDS) approved The Ministry of Food and Drug Safety (MFDS) stated that on May 29th, it has granted approval of the orphan drug 'Pluvicto inj (Lutetium(177Lu) Vipivotide Tetraxetan)' for the treatment of prostate cancer. Pluvicto is imported by Novartis Korea. It is a radioligand therapy comprised of radioisotope Lutetium(177Lu), which binds to prostate-specific membrane antigen (PSMA), commonly expressed in prostate cancer, delivering therapeutic radiation to prostate cancer, leading to cell death of cancer cells. Pluvicto inj has been approved for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and ‘taxane‘-based chemotherapy. The MFDS stated that in June last year, it has designated Pluvicto inj as the '6th Global Innovative products on Fast Track (GIFT)' and expects to provide a new treatment opportunity for prostate cancer patients who cannot receive conventional therapies. The MFDS said, "We will continue to make efforts to expand treatment opportunities for rare and refractory diseases by ensuring the expedited distribution of medications with proven safety and effectiveness based on our expertise in regulatory science.”
- Policy
- Korea-US gov't pledge to strengthen biohealth cooperation
- by Lee, Jeong-Hwan May 31, 2024 05:51am
- The Korean government has decided to strengthen cooperation with the U.S. Department of Commerce in the field of telemedicine and digital health, including non-face-to-face medical treatment. CareLabs and Lulu Medic, Korea’s leading healthcare platforms including domestic non-face-to-face treatment applications, Teladoc, the No. 1 telemedicine provider in the U.S., and Baxter, a global healthcare company, had the opportunity to present their major business achievements to the two governments. At 8 a.m. (KST) on the 30th, the Ministry of Trade, Industry and Energy (MOTIE) announced that it held the 'Korea-US Telemedicine Showcase' with the U.S. Department of Commerce via video. The showcase was held to enhance mutual understanding of the digital health and telemedicine industries in the two countries and explore ways for cooperation. The MOTIE assessed that the digital health industry is expected to continue to grow due to the rapidly aging population and improved quality of life. In particular, the ministry said that mobile app-based non-face-to-face medical treatment is gaining commercial results. The showcase was jointly organized by MOTIE, the U.S. Department of Commerce, digital health associations from both countries and 30 promising digital health companies from both countries. Among associations, the Korea Digital Health Industry Association (KoDHIA) from Korea and the American Telemedicine Association (ATA) from the U.S. attended the event. By company, CareLabs and Lulu Medic, Korea’s leading healthcare platforms including domestic non-face-to-face treatment applications, and Teladoc, the No. 1 telemedicine provider in the U.S., and Baxter, a global healthcare company, presented their major business results and future plans. The MOTIE plans to strengthen all-around cooperation in the bio industry, including pharmaceuticals, medical devices, and materials, parts, and equipment industries, through 'Bio USA 2024,' which will be held from the 3rd to the 4th of next month. A MOTIE official said, "We are promoting policies such as supporting the commercialization of products and services and fostering human resources to create a digital health industry ecosystem. Building on the telemedicine showcase we held this time, we plan to continue our bilateral digital health cooperation.”
- Company
- Delay after delay…When will Phesgo be reimb in Korea?
- by Eo, Yun-Ho May 31, 2024 05:51am
- The biobetter breast cancer treatment ‘Phesgo’ is facing a tough road to insurance coverage in Korea. Roche Korea’s subcutaneous fixed-dose combination injection Phesgo (pertuzumab, trastuzumab) that combined ‘Perjeta’ and ‘Herceptin’ has passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review in August last year. After reporting to the Drug Reimbursement Evaluation Committee review, Roche started negotiations with the National Health Insurance Service regarding the supply and quality control obligations for Phesgo but had made no progress. The 60-day deadline for negotiations has already passed, and no agreement has been reached in the extended negotiation period. It has now been 10 months since the CDDC review. As a biobetter that is an improved version of an existing drug, Phesgo’s drug price negotiations were expected to go smoothly at first, but the government was more concerned about its fiscal impact than expected and made additional demands to Roche. The good news is that both the government and the pharmaceutical company are willing to reimburse the drug, so it is possible that the parties will reach a negotiation in the future. In the case of ‘Nexviazyme (avalglucosidase alfa),’ which was the first case of preferential pricing granted to a biobetter drug, the process to its reimbursement listing took 5 months. It remains to be seen how long the tug-of-war between the government and Roche, which began last year, will continue. Phesgo was recognized for its innovation in improving patient convenience and reducing treatment time by changing the IV-injected Herceptin and Perjeta into a fixed-dose subcutaneous injection and was named the first biobetter approved for cancer in Korea. Metastatic HER2-positive breast cancer patients who had received maintenance therapy with IV Herceptin and Perjeta injections every three weeks may reduce their administration and monitoring time by 90% from the 270 minutes (90min+180min) to 20 minutes (5min+15min) when switching to Phesgo. Also, as Phesgo is a subcutaneous formulation injected in the thigh rather than into the veins, it can reduce blood vessel and nerve damage that can be caused by repeated intravenous injections. These benefits of Phesgo could prove to be useful amid the current healthcare disruptions. However, delays in the process, which could have been listed as early as the end of last year, have left Phesgo a pie in the sky. The NCCN guidelines state that Phesgo can be used in the place of Perjeta and Herceptin, In fact, in the UK, 90% of patients treated with Herceptin and Perjeta switched to Phesgo within a year after its launch. Therefore. If listed, a significant number of patients receiving Herceptin-Perjeta treatment are expected to switch to Phesgo as well. In 2016, the government announced a plan to provide preferential pricing for biosimilars and biobetters, which are improved versions of already approved biopharmaceuticals, that have contributed to the improvement of Korea’s healthcare. In the case of biobetters (chemical drugs), considering the difficulty in developing compared to improved new drugs (synthetic drugs), it was decided to calculate it at 100-120% of the drug price of the development target product (original, etc.), and Nexviazyme became the first drug to benefit.
- Policy
- Research on reforming post-management of pharmaceuticals
- by Lee, Tak-Sun May 30, 2024 05:50am
- The government has initiated research on developing a comprehensive reform of post-insurance management of pharmaceuticals. This research was part of the 2nd Comprehensive NHI Plan, announced earlier this year. According to industry sources on May 29th, a policy initiative reporting session was held to announce the start of the research on post-insurance management of pharmaceuticals. As part of the 2024 initiative plan for the 2nd Comprehensive NHI plan, which was announced last month, policy initiative research will be conducted to develop a comprehensive reform of post-insurance management of pharmaceuticals. This plan aims to effectively manage the cost of pharmaceuticals as part of a mid-to-long-term strategy. The research will include the current state of the post-insurance management program, accomplishments, comparisons to foreign countries, and suggestions for improving the program to suit South Korean settings. The MOHW announced that the research will start in May and be completed by December. The Korea Institute for Health and Social Affairs (KIHASA) will conduct the research under a contract with the MOHW. "The research aims to develop a comprehensive reform of the post-insurance management of pharmaceuticals, including the Health Insurance Review and Assessment Service (HIRA)’s reevaluation of reimbursement appropriateness and the National Health Insurance Service (NHIS)’s Price-Volume Agreement (PVA) program," a government official explained. “Therefore, the MOHW, the HIRA, and the NHIS officials have joined the reporting session.” Earlier this year, there were talks of a possible reevaluation of comparisons to foreign pharmaceutical pricing following the research on the comprehensive measures for post-insurance management of pharmaceuticals. However, it appears that there are plans to separately pursue the reevaluation of comparisons to foreign pharmaceutical pricing this year. When the research report is available at the end of this year, there will be a discussion on systemization next year.
- Opinion
- [Reporter’s View] We don’t know the fate of rivoceranib
- by Kim, Jin-Gu May 30, 2024 05:50am
- On the 17th, The US Food and Drug Administration issued a complete response letter (CRL) for HLB and Chinese Jiangsu Hengrui Pharmaceuticals’ frontline camrelizumab plus rivoceranib as a treatment for those with unresectable or metastatic hepatocellular carcinoma (HCC). Immediately after the news broke, HLB's stock price plummeted. The stock price, which was KRW 95,800, hit the floor for two days in a row, halving to KRW 47,000. Its market cap evaporated by more than KRW 630 billion in 2 days. As investors had high expectations for the company, which once recorded the second-largest market cap on KOSDAQ, the disappointment was as great. However, its stock has since rebounded, especially on the 27th and 28th, rising by more than 10% for two consecutive days and recovering to the KRW 63,500 level. The analysis is that HLB's strong claim that the FDA's approval was only delayed due to the facility issue at Jiangsu Hengrui Pharmaceuticals and that there is no problem with its final approval, has brought back the investors' attention again. Interpretations of the companies’ CRL receipt had been mixed. Some have said that the FDA "denied" the approval or that the companies have "failed," while others say the approval was just "delayed" or "pending. There is no special meaning to a CRL. It doesn't mean that the possibility of an FDA approval is long gone or that your approval is assured. Receipt of a CRL literally means that the FDA has requested a supplement to the application. Of course, as HLB claims, many new drugs have crossed the FDA threshold after receiving a CRL. HLB and Jiangsu Hengrui Pharmaceuticals plan to reapply for the FDA’s approval. They plan to resolve the facility issues that were pointed out as the reason for the CRL and try again. The exact time of the reattempt was not disclosed, but the industry expects the companies to reapply 'soon.’ We cannot predict whether the reattempt will end a success or failure. While many factors favor a positive outcome, there are also clear factors that point to a negative outcome. According to HLB claims, the CRL was unrelated to the efficacy and safety of the combination therapy. If so, this means that the combination therapy’s longest overall survival (OS) data compared to competing drugs is acceptable. In this case, the reapplication would only need to address the Jiangsu Hengrui Pharmaceuticals’ facility issues that caused the CRL. However, it is different if there are other causes besides the facility issue. In the past, the pharmaceutical industry has criticized the camrelizumab plus rivoceranib combination trial for not being double-blinded and for having a disproportionately large number of Asian patients. There are also other variables beyond the clinical and facility issues. One risk is that the US has been slow to approve new drugs from China for political reasons. The US recently passed the Biosecure Act, which actively restricts activity by Chinese pharmaceutical companies. Furthermore, the imminent release of clinical data of a potential competitor, the Opdivo plus Yervoy combination as a first-line treatment for liver cancer, also renders it difficult to be optimistic about the outcome. HLB Chairman Yang Gon Jin called the CRL a "double hit" for the company. However, it's too early to assess whether it's a double or a triple hit based solely on the FDA’s rejection or delay of approval. The ball hit by the HLB is still in flight. At this point, the ball could go over the fence or be out. Even if the FDA approves the product, the approval by itself would be hard to call a success. While it's clear that crossing the FDA's threshold is very difficult, it shouldn't be the ultimate goal. It’s as important to have a vision of how to commercialize the product after approval. So from various aspects, it is clear that it is too early to call rivoceranib a success or a failure, just based on the receipt of the CRL.
