The latest data released by the World Health Organization shows that the incidence of breast cancer in the world has jumped to the first place, and the incidence of breast cancer in China is also on the rise. HER2-positive breast cancer is the most common molecular type, accounting for about 20-25% of breast cancer patients[1]. This subtype has the characteristics of strong invasiveness, insensitivity to traditional chemotherapy, easy recurrence, and poor prognosis. Therefore, HER2-positive breast cancer is known as one of the most dangerous types of breast cancer.
Trastuzumab is the cornerstone of anti-HER2-positive breast cancer treatment, and long-term clinical problems need to be solved urgently< /p>“Trastuzumab” is no stranger to patients with HER2-positive breast cancer, and plays a very important role in the treatment of this subtype of breast cancer. Zizumab-based regimens have changed the treatment landscape for HER2-positive breast cancer and are the cornerstone in neoadjuvant, adjuvant, and advanced breast cancer treatments. In 2002, trastuzumab was approved for marketing in China, which brought great changes to the domestic HER2-positive breast cancer treatment landscape. Challenges are encountered in clinical use. It is well known that the average body weight of Chinese patients is lighter than that of European and American populations. When using large-scale (440mg/vial)trastuzumab, it is not possible to better determine the patient’s body weight. , Each dose is given a personalized medication plan, which can only be used in the whole bottle. Generally, large-scale preparations cannot be used up at one time. Based on the price of the drug, the remaining unused medicinal liquid is usually stored and used until the next treatment cycle. Resulting in the need for “residual fluid management”. From a medical point of view, the “residual fluid management” of drugs can easily cause patients to have doubts about safety. In order to reassure patients and ensure stable efficacy during the “remaining fluid storage” period, a preservative containing benzyl alcohol is added to the dilution of trastuzumab. Benzyl alcohol, as the most common preservative, has antiseptic and analgesic effects, and is also used as an excipient for injection. The clinical use of intravenous infusion solutions containing benzyl alcohol as a preservative may cause adverse reactions such as hemolysis, that is, bruising often occurs at the injection site; and it has certain side effects on the central nervous system, causing dizziness, headache, blurred vision, and nausea. vomiting, etc. The EU guidelines for the application of marketing excipients for medicinal products stipulate that antibacterial preservatives should not be added to parenteral infusions[2] span>, and the 2020 edition of the Chinese Pharmacopoeia also pointed out that no bacteriostatic agents should be added to intravenous injections ( Note: Preservatives used in injections are often called bacteriostatic agents). From the perspective of “preservation of residual liquid”, if a hospital is selected for storage, according to the quality control standards, each nurse generally manages medicines for multiple patients at the same time, and the workload is heavy. , which takes up too much time and energy that nurses should spend on the physical and mental care of patients. In addition, during the repeated outbreak of COVID-19, force majeure factors such as sudden hospital closures may result in patients being unable to arrive at the hospital on time to use trastuzumab, which may be wasted and delay the treatment of patients, which has a very negative impact on the therapeutic effect. . In this regard, some patients choose to take the “residual fluid” home for preservation. The storage temperature of trastuzumab is 2-8°C. Patients cannot ensure that the drug is in a constant temperature state on the way to and from the hospital. If it is stored at home, it may be mixed with food, etc., resulting in improper storage, affecting the efficacy of the drug, and inability to use it, resulting in waste. “Preservation of residual fluid” is inconvenient and risky for both hospitals and patients, and it is the patients who bear these risks. Therefore, Chinese patients are looking forward to a trastuzumab that is safer and more convenient for clinical use without the need for residual liquid storage and preservatives.
The first “Chinese” Trastuzumab: Tailored for Chinese HER2-positive patients , to meet clinical drug needs
The first domestic trastuzumab Hanquyou ® came into being. The trastuzumab was launched in the EU and China in July and August 2020, becoming the first “China-Europe double batch” of “Chinese” trastuzumab for the treatment of HER2-positive early breast cancer , metastatic breast cancer and metastatic gastric cancer, providing a new treatment option of international quality for the field of anti-HER2 in my country. Its initial marketed strength is 150mg, and a new 60mg strength will be approved for marketing in August 2021. Double-dose, small-dose form provides a flexible solution for Chinese HER2-positive breast cancer patients. The combination of drugs facilitates individualized and more economical treatment of breast cancer patients with different weight ranges. Moreover, the flexible deployment of this two-dose form can be used in clinical medication, making clinical care more convenient, eliminating the trouble of “residual fluid management”, and avoiding the phenomenon of “residual fluid expiration”. The feature of no need for “residual fluid preservation” has been widely praised by doctors and patients since its launch two years ago, and another advantage of domestic trastuzumab – no The addition of preservatives avoids potential side effects caused by preservatives, reduces the concerns of patients with medication, and escorts the therapeutic effect. Break the “pain points” of clinical use, relieve the difficulties of patients and maximize their benefits, domestic trastuzumab Hanquyou® did it. At present, this trastuzumab is covered by the basic medical insurance fund and has benefited nearly 70,000 patients in China.
“Light of domestic products” is equivalent to high quality, and has been recognized by domestic and foreign authorities, and its accessibility has been continuously improved span>
Quality is the cornerstone of medicine and determines the effect of treatment. Hanquyou® has been widely recognized for its international quality since its launch. The final analysis of its head-to-head international multicenter Phase III clinical study showed that Hanquyou®® span>Compared with the original trastuzumab group, there is no clinically significant difference in efficacy, safety and immunogenicity, and it can be used as an affordable and high-quality domestic alternative in the field of HER2-positive breast cancer span>[3]. In terms of quality assurance of production, the Henlius Xuhui Base, the production base of the drug, is the first in China to obtain dual GMP in China and the EU (“Drug Production Quality Management”). Standard”)certified as a GMP factory for the production of self-developed antibody biological drugs. The high standards and strict requirements provide a strong guarantee for the international quality of this “light of domestic products”. In 2022, the company’s newly approved Songjiang base(1)has also obtained the certification of GMP and other production management systems. The strong production capacity and strict production management will fully Meet the growing market demand and make patients more at ease when taking medication. With premium quality, Hanqu is excellent®It has also been recognized by the international biopharmaceutical market. At present, Henlius has joined hands with overseas business partners to comprehensively deploy markets in the United States, Canada, Australia, Europe and many emerging countries, covering more than 90 countries and regions. Up to now, Hanquyou® has been sold in the European Union, Australia and other nearly 30 It has been approved in many countries, and has been successfully marketed in nearly 20 European countries, and has been widely used in clinical practice.
Ambition—Leave a HER2-positive patient behind strong>
Hanquyou ®With the flexible dosing method of “small size and multiple combinations”, HER2-positive breast and gastric cancers in China and around the world can be treated Patients have more options for medication, which is helpful for long-term medication and full care, so that patients can achieve good cure and achieve high-quality survival. It is expected that Chinese pharmaceutical companies will launch more new products in the future to save patients’ costs and reduce their worries.
References:[1]. Mitri Z, Constantine T, O’Regan R: The HER2 receptor in breast cancer: pathophysiology, clinical use, and new advances in therapy. Chemother Res Pract 2012; 2012:743193[2]
London, 19 June 2007 Doc. Ref. EMEA/CHMP/QWP/396951/2006.[3] Cancer Outlook. Academician Xu Binghe: The Advancement of Biosimilars——Han Quyou (Trastuzumab) International Multicenter Phase III Clinical Trial HLX02-BC01 Announces 3-Year OS Results, 2022-07-11.