Can the price of imported drug breast cancer be cut in half?Domestic competitors are on the rise
How does Roche emmetrastuzumab work?Linan failed to get on the special train with high volume of medical insurance. Can roche emmetrastuzumab achieve an increase in the Chinese market after its price was reduced by more than half?The HER2 ADC drug market has huge potential, and roche will respond to a cluster of similar targets…Recently, Liaoning province, Jiangsu Province, Shaanxi Province and other provinces have announced thatThe online prices of emmetrastuzumab 100mg and /160mg for injection of Roche were adjusted from 19282 yuan to 9200 yuan and from 27632.04 yuan to 13184.05 yuan, respectively, with a decrease of 52.3%.The reason for the price adjustment is nothing more than that enterprises submitted the initiative to reduce the application, and then some provinces have adjusted the online price dynamically according to the drug sunshine online program.This is the first price cut for Roche’s emmetrastuzumab since it was launched in China in 2020, and roche has not budked even in healthcare negotiations.Emmetrastuzumab (Kadcyla, T-DM1, Chinese trade name:Developed by Roche and ImmunoGen, her2-targeting trastuzumab is an anti-her2-targeting antibody conjugate (ADC drug) linked by a thioether ligand to DM1, a chemotherapeutic agent that inhibits microtubule aggregation.In 2013, Emmetrastuzumab was approved for marketing in the United States and has been approved for the treatment of PATIENTS with HER2-positive metastatic breast cancer and adjuvant treatment of patients with her2-positive early breast cancer.Since its launch, Emmetrastuzumab has rapidly gained prominence in the global market due to its remarkable efficacy and unique mechanism, and has the potential to become the new “troika” of Roche oncology.In 2019, the sales volume of this drug reached 1.393 billion Swiss francs, which has grown into the backbone of Roche in this field.In 2020, the global market sales reached 1.745 billion Swiss francs, up 25% year on year.In 2021, benefiting from KATHERINE’s positive results, patients switched to the new standard therapy, especially in the early-stage breast cancer population. All regions showed sales growth, achieving revenue of CHF 1.982 billion, up 16% year-on-year, making it the world’s largest antibody-coupled drug by sales for the year.Roche’s blockbuster drug was approved in China in January 2020 for the adjuvant treatment of her2-positive early-stage breast cancer patients with residual invasive lesions after receiving neoadjuvant therapy based on taxanes combined with tratozumab.In June 2021, emmetrastuzumab received approval for a second indication in China for her2-positive, unresectable locally advanced or metastatic breast cancer in patients receiving taxane and trastuzumab monotherapy.After the launch of Enmeizumab, the two specifications were priced at 19,282 yuan /100mg and 27,633 yuan /160mg respectively in China.As recommended by the drug label, the dose per patient should be 3.6mg/kg per body weight, given intravenously every 3 weeks for a 21-day period until disease progression or no more than 14 cycles.There is no need to adjust the dose if the patient’s body weight does not change more than 10% during treatment.Taking an ordinary adult patient (60kg) as an example, the annual treatment cost of the drug reached 650,000 yuan, and the annual treatment cost after the drug donation was about 328,000 yuan.According to the rules of medical insurance negotiation, only drugs whose annual treatment cost is less than 500,000 yuan can be qualified for negotiation. According to the current drug payment limit, only drugs whose annual treatment cost is less than 300,000 yuan can get the final ticket.The price cut for Roche’s Emmetzizumab is also close to the average reduction in healthcare negotiations.In 2020, emmettrastuzumab was put on the preliminary list for medical insurance, but the negotiations were not successful.In the 2021 medicare negotiations, emmettrastuzumab did not even make it onto the preliminary list for medicare.In just two years, Roche has finally put down its high profile and cut prices after two rounds of healthcare negotiations and even before the next round (2022), which shows the pressure roche is facing.What is noteworthy is that the relevant person in charge of Roche China explained in an interview to the media that this is a nationwide price reduction strategy, which has been implemented in various places.The main purpose is to reduce the burden of terminally ill patients as much as possible through this price reduction, not out of consideration of market competition.At the same time, Roche China has been promoting Hercelet’s entry into the national health insurance, and this initiative to reduce the price is also a sign of sincerity.02 Sluggish domestic sales?Same target drug price rolling…However, the industry was not surprised by roche’s emmetrastuzumab price cut and felt it was inevitable.Some analysts believe that emmettrastuzumab is not popular in China due to its high pricing.After its launch in 2020, the annual sales of emmettrastuzumab in sample hospitals were only 16.65 million yuan, according to Data from Wind Pharmaceutical Database.Second, Roche’s Emmetrastuzumab also came from the direct impact of other domestic competitors, especially after the healthcare negotiations.Among the three ADC drugs currently on the market in China, Vidisetuzumab of Rongchang and Emmetrastuzumab of Roche (trade name: Heselai) are both HER2 targets.Vidisetuzumab of Rongchang Bio was approved for marketing in June 2021, with an annual cost of about 340,000 yuan for gastric cancer indication after drug donation.Since then, the price of vidisetuzumab of rongchang biological was rapidly reduced to enter the list of medical insurance. The 60mg of vidisetuzumab was reduced from the original 13,500 yuan to 3800 yuan, a decrease of 71.85%.In addition to ADC, there are two categories of her-2 targeted drugs listed in China: monoclonal antibodies and small-molecule targeted drugs.Among them, the indications of small molecule targeted drugs are basically the same as those of ADC drugs, mainly focusing on second-line adjuvant therapy for early breast cancer and second-line therapy for advanced breast cancer.Since the main indication is first-line therapy and adjuvant therapy for breast cancer, macromolecular mab does not directly compete with ADC drugs.Although they are ADC drugs with the same target, the indication of Vidisetuzumab of Rongchang Bio is mainly targeted at gastric cancer, so it is still a small molecule targeted drug that directly competes with Emmetrastuzumab of Roche.Small molecule targeting drugs are mainly lapatinib, pyrrolatinib, neratinib.In addition to lapatinib has been called out of the catalogue of health insurance, according to everbright Securities statistics, pyrroetinib into health insurance, the price reduction reached 66.3 percent.The patient originally had to pay about 27,000 yuan per month, but after entering the medical insurance system, the patient’s out-of-pocket expenses will be between 1,059 yuan and 3,178 yuan after being reimbursed by the medical insurance system, i.e., the annual expense will be up to 38,000 yuan.Neratinib was also included in the medical insurance through negotiation in 2021, and the annual treatment cost was reduced from 200,000 to 80,000, only 24,000 after reimbursement……Similar to PD-1, ADC drugs are composed of monoclonal antibodies and small molecule toxins conjugated by ligons. With advantages of precise targeting of monoclonal antibodies and efficient killing of cytotoxins, ADC drugs are also known as “biological missiles” and have great clinical value.Due to the unique advantages of ADC drugs, now the global ADC research and development boom is set off.According to citic Securities, up to now, 14 ADC drugs have been approved for marketing worldwide, including 7 for hematological tumors and 7 for solid tumors, targeting CD33, CD30, CD22, CD79b, HER2, NECtin-1, TROP-2, BCMA, EGFR, CD19 and TF.Among them, four ADC drugs are available in China.Adcetris and Kadcyla were approved by NMPA in China in 2020, While Vedisetuzumab, independently developed by Rongchang, was approved in China in June 2021, and Besponsa was approved in China in December 2021.ADC has become another popular track after PD-1, especially in mature targets such as HER2 and TROP2.At the same time, ADC technology is becoming more mature and products are constantly updated and iterated.Enhertu’s head-to-head phase III trial against Kadcyla, a second-generation ADC, demonstrates the clinical benefits of this innovation.Enhertu was approved by the U.S. Food and Drug Administration (FDA) in December 2019 for the treatment of adults with her2-positive metastatic breast cancer who have previously been treated with two or more anti-HER2 drugs in their metastatic disease.Enhertu has replaced Kadcyla as the second-line treatment of choice for HER2-positive breast cancer in the NCCN breast cancer guidelines. Kadcyla’s status is precarious.In addition, Enhertu has also conducted several phase 3 clinical trials in Breast cancer in China, and its phase 3 MRCT clinical trials with Emmetrastuzumab have been conducted in China for more than two years, so it may only be a matter of time before the market filing.Insight database shows that at present, there are many domestic enterprises distributing HER2 ADC drugs. In addition to the two drugs already listed by Roche and Rongchang Bio, domestic enterprises with rapid progress include Dongyao Pharmaceutical, Zhejiang Pharmaceutical, Shiyao Group and Hengrui Pharmaceutical.The BAT8001 ADC, a recombinant humanized HER2 monoclonal antibody conjugate for injection, was also in development. However, in February 2021, The company announced the termination of the ADC program, which was also in development, to the disappointment of the industry.As for the reason for the suspension, Biocatea said it was mainly due to the company’s preliminary statistical analysis, the main efficacy indicators of the drug progression-free survival compared to the control group (lapatinib combined with capecitabine) did not reach the preset goal of superior efficacy, so it was terminated.It is understood that Baiotai has invested 226 million yuan in the project.According to citic Securities estimates, the domestic market space of HER2 ADC drugs is expected to exceed 3 billion yuan by 2025.With a cluster of HER2 targets, roche emmettrastuzumab will face more and more challenges with the launch of rival products and patent expiration.