On the evening of April 17, Hengrui Pharmaceutical (600276) announced its operating results for the first quarter ended March 31, 2024. In the first quarter of this year, Hengrui Pharmaceutical achieved operating income of 5.998 billion yuan, net profit attributable to shareholders of listed companies of 1.369 billion yuan, and non-net profit attributable to shareholders of listed companies of 1.440 billion yuan, an increase of 9.20%, 10.48% and 18.06% respectively. On the basis of last year, the company's performance continued to rebound steadily. It is worth noting that the net operating cash flow increased by 486.35% during the reporting period, which the company said was due to the increase in revenue and the acceleration of customer payment collection in the reporting period, and the increase in cash received from the sale of goods.
In addition, the report shows that the company received a down payment of 160 million euros from Merck Healthcare for the out-licensing period in the reporting period, and the relevant performance obligations have not yet been completed, and the relevant revenue has not yet been recognized. According to the analysis of industry insiders, it may be that the relevant patents and technologies have not yet been fully delivered, and the revenue recognition conditions of accounting standards have not yet been met, and it is common for there to be a difference between the time of license revenue recognition and the time of collection.
Hengrui Pharmaceutical's R&D expenses in the first quarter of 2024 reached 1.22 billion yuan, and the transformation of innovative R&D achievements was accelerated. In terms of new drug approval, Hengrui's self-developed Class 1 new drug Tygilidine Fumarate Injection (Aisute ®) was launched for the treatment of moderate to severe pain after abdominal surgery, which is the first Class 1 opioid analgesic innovative drug independently developed in China, providing a new treatment option for patients who are deeply troubled by postoperative pain. At present, Hengrui has been approved for marketing 16 Class 1 innovative drugs and 4 Class 2 new drugs in China. The marketing authorization application for a new class 1 drug, venakizumab injection (SHR-1314), was accepted by the NMPA for the treatment of adult patients with active ankylosing spondylitis with poor conventional treatment, and the marketing authorization application for the second indication of tegillidine fumarate for the treatment of moderate to severe pain after orthopedic surgery was accepted by the NMPA.
Since the beginning of this year, Hengrui's innovative drug clinical trials have continued to advance efficiently, and two breakthrough therapy designations have been obtained, namely: HER2 SHR-A1811 for ADC injection for HER2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma that has failed at least one prior anti-HER2 therapy, and the innovative drug fluzoparib alone or in combination with apatinib for the treatment of epidermal growth factor receptor 2 (HER2)-negative breast cancer with germline breast cancer susceptibility gene (gBRCA) mutation, and the company's Class 1 innovative oral small molecule GLP-1 receptor agonist HRS-7535 tablets for bariatric indications have also been approved for clinical trials.
The company's HER2 ADC star product, SHR-A1811, continues to perform well, and has received a total of 5 breakthrough therapy designations, covering breast, lung, colorectal, gastric or gastroesophageal junction adenocarcinoma. Based on Hengrui's modular ADC innovation platform (HRMAP), after 10 years of ADC R&D accumulation, Hengrui has become a domestic enterprise with advanced progress in the layout of popular targets and many differentiated ADC products, and 11 new and differentiated ADC molecules have been successfully approved for clinical trials.
In terms of international clinical trials, the company's self-developed CD79b ADC innovative drugs SHR-A1912 for injection and SHR-A1921 for TROP-2 ADC injection have been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory diffuse large B-cell lymphoma (R/R) who have received at least two prior lines of therapy DLBCL), and for the treatment of platinum-resistant recurrent epithelial ovarian cancer, which is expected to accelerate the progress of clinical trials and marketing registration. At present, Hengrui has 3 products that have obtained FDA fast-track qualification.
Hengrui's innovative R&D achievements continue to shine on the international academic stage. At the 2024 European Conference on Lung Cancer (ELCC), the long-term follow-up data of the innovative drug camrelizumab combined with carboplatin and pemetrexed versus chemotherapy for the first-line treatment of driver-negative advanced non-squamous non-small cell lung cancer (NSCLC) (CameL study) was unveiled: the 5-year overall survival (OS) rate of camrelizumab combined with chemotherapy in the first-line treatment of advanced driver-negative non-squamous non-small cell lung cancer reached 31.2% (19.3% in the chemotherapy group), which means that nearly 1/ The survival time of 3 patients with advanced lung cancer exceeded 5 years, which is another positive contribution made by Hengrui Pharmaceutical, as a representative enterprise of Chinese pharmaceutical (600056) innovation, to prolong the life of cancer patients.
In addition to the traditional advantages in the field of cancer treatment, Hengrui's academic achievements in the field of chronic diseases have also been continuously recognized: the results of the study on the use of the anesthetic analgesic drug esketamine for the prevention of postpartum depression were published online in the British Medical Journal (BMJ, IF: 105.7), one of the four major medical journals in the world. The results of the phase III study of the company's self-developed JAK1 inhibitor and innovative drug imaxitinib (SHR0302) for the treatment of moderate to severe atopic dermatitis (AD) were presented as oral reports at the 82nd Annual Meeting of the American Academy of Dermatology (AAD), and a number of important studies were presented at the 2024 American Society of Clinical Oncology Gastrointestinal Oncology Symposium (ASCO GI), the American Society of Gynecologic Oncology (SGO) and other well-known academic conferences.
While focusing on the high-quality development of the enterprise, Hengrui has also been striving to make the development results better benefit people's livelihood and give back to the society. Recently, the 2024 "Aiwei New Journey, Healthy China Tour" science popularization special action supported by Hengrui Public Welfare has been launched, and domestic authoritative experts will be invited to hospitals, enterprises, schools, and communities across the country to spread health knowledge, organize popular science lectures, and carry out popular science consultation;
With the results of high-quality development, Hengrui Pharmaceutical has repeatedly won good results in various selections. Recently, Citeline, an internationally renowned consulting agency, released the "2024 Annual Review of Pharmaceutical R&D" and selected the world's top 25 pharmaceutical companies with pipeline scale, Hengrui entered the list for the third time to compete with the world's large multinational pharmaceutical companies, ranking 8th, setting a new high for Chinese pharmaceutical companies; Hengrui also appeared on the list of "2023 Hurun Global 500" this year, ranking 366th; in February this year, according to the well-known pharmaceutical industry media "E Drug Manager" According to statistics, Hengrui ranked 18th in the top 20 global pharmaceutical companies in terms of market capitalization, becoming the only Chinese pharmaceutical company in the top 20.