Domestic innovative drugs are gradually entering the harvest period, and 1 billion yuan of single products are frequent

Source: Economic Information Daily

In recent years, the R&D of new drugs by mainland pharmaceutical companies has been continuously enhanced, and the number of new drugs entering the clinical stage and applying for marketing has grown rapidly. According to the announcement of listed companies, the reporter found that since May, many listed pharmaceutical companies such as Yunnan Baiyao, Baili Tianheng, Hengrui Pharmaceutical, and Microchip Biotechnology have disclosed the latest progress of innovative drugs, and a number of innovative drugs have been approved for clinical trials, and one type of innovative drug has been approved for marketing. Looking back at 2023, domestic innovative drugs will gradually enter the harvest period, and blockbuster products with annual sales of more than 1 billion yuan (RMB, the same below) will appear frequently.

A number of pharmaceutical companies disclosed the progress of innovative drugs

Since May, a number of A-share listed pharmaceutical companies have disclosed the latest progress in clinical trials of innovative drugs.

Hengrui Pharmaceutical has recently disclosed the clinical research of three innovative drugs, and the total R&D expenses of the three drugs have exceeded 100 million yuan. On May 14, Hengrui Pharmaceutical announced that its subsidiary, Guangdong Hengrui Pharmaceutical Co., Ltd., received the "Notice of Approval of Drug Clinical Trials" approved and issued by the State Drug Administration, approving the clinical trial of SHR-2173 injection, a new drug in class 1, for IgA nephropathy. At present, there are no similar drugs of SHR-2173 on the market or in the clinical development stage at home and abroad. Up to now, about 18.93 million yuan has been invested in R&D projects related to SHR-2173 injection. On the 9th, Hengrui Pharmaceutical disclosed that two drugs were approved for clinical trials, and its two subsidiaries received the "Drug Clinical Trial Approval Notice" approved and issued by the State Food and Drug Administration, involving HRS-5965 capsules and HRS5580 for injection. According to the announcement, a total of about 20.87 million yuan has been invested in R&D expenses for HRS5580 for injection, and about 64.07 million yuan has been invested in R&D expenses for HRS-5965 capsules.

On May 14, Poinsettia announced that the application for clinical trials of APH01727 tablets, a class of innovative drugs independently developed by its wholly-owned subsidiary, was recently accepted by the State Food and Drug Administration. APH01727 tablets are a highly active and selective glucagon-like peptide-1 receptor agonist (GLP-1RA) independently developed by the company, which is intended for the treatment of patients with type 2 diabetes and overweight/obesity.

On May 13, Chipscreen Biosciences announced that the randomized, open-label, controlled, multicenter, phase III clinical trial of chidamide combined with sintilimab and bevacizumab for the ≥treatment of advanced microsatellite stable or mismatch repair intact (MSS/pMMR) colorectal cancer that has failed 2nd line of standard therapy has been accepted by the Drug Evaluation Center of the State Food and Drug Administration. On the same day, Mabwell disclosed that the clinical trial application of 9MW2821, an innovative drug developed by the company with independent intellectual property rights, in combination with immune checkpoint inhibitors for the treatment of triple-negative breast cancer, has been accepted by the State Food and Drug Administration.

Earlier, Yunnan Baiyao, Bio-Thera, Baili Tianheng, Tonghua Dongbao and other companies also disclosed the progress of innovative drugs, including ADC and other popular drugs.

On May 10, Bio-Thera disclosed that the company's clinical trial application for the treatment of advanced solid tumors in combination with BAT8006 drug BAT1308 was approved. BAT1308 injection is a humanized anti-PD-1 monoclonal antibody independently developed by Bio-Thera, BAT8006 an antibody-drug conjugate (ADC) targeting folate receptor α (FRα) developed by Bio-Thera. According to the annual report, the above two drug registration classifications are "therapeutic biological products 1".

On the same day, Baili Tianheng announced that its self-developed innovative biological drug BL-B16D1 recently received the "Drug Clinical Trial Approval Notice" officially approved and issued by the State Food and Drug Administration. BL-B16D1 is a bispecific antibody ADC drug conjugated to a new generation of toxins independently developed by the company, and its indication is advanced solid tumors. The company also disclosed on May 7 that its self-developed innovative biological drug BL-B01D1 for injection (EGFR×HER3-ADC) related combination drug "BL-B01D1 + PD-1 monoclonal antibody ±chemotherapy" was approved to carry out clinical trials for "advanced gastric cancer", "advanced small cell lung cancer", "advanced triple-negative breast cancer", "advanced urothelial carcinoma", "advanced esophageal squamous cell carcinoma", "advanced head and neck squamous cell carcinoma" and "advanced nasopharyngeal carcinoma".

In addition, among the listed pharmaceutical companies in Hong Kong, China Biopharma announced on May 9 that Benmelstobart (TQB2450), a Class 1 innovative drug independently developed by the group, has been approved by the State Food and Drug Administration of China for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

Jacobio announced on March 10 that its self-developed KRAS G12C inhibitor Glecirasib (JAB-21822) and epidermal growth factor receptor (anti-EGFR antibody) inhibitor ERBITUX (cetuximab) have been approved for a registrational Phase III clinical trial in China for the treatment of KRAS G12C-mutant colorectal cancer. Laekna Therapeutics announced that the Center for Drug Evaluation (CDE) of the NMPA has approved the investigational trial of LAE102 for the treatment of obese patients.

The R&D of new drugs continues to increase

In recent years, mainland pharmaceutical companies have continued to increase R&D investment, and the R&D of new drugs has been continuously enhanced.

According to the "2023 Drug Evaluation Report" released by the State Food and Drug Administration in February this year, 40 Class 1 innovative drugs will be approved for marketing in 2023. Among them, there are 19 chemical drugs, 16 biological products, and 5 traditional Chinese medicines.

According to the statistics of Flush data, the reporter found that in the first quarter of this year, the total R&D expenses of 479 A-share listed pharmaceutical companies that disclosed relevant data were 26.865 billion yuan, an increase of 3.18% from 26.037 billion yuan in the first quarter of 2023. Among them, 284 R&D expenses increased compared with the previous year, and the number of enterprises accounted for nearly 60%.

Specifically, the R&D expenses of many pharmaceutical companies increased by more than 50% year-on-year. For example, BeiGene's R&D expenses in the first quarter of this year were 3.328 billion yuan, up 50% from 2.818 billion yuan in the same period last year. Affected by the year-on-year increase of 74.78% in operating income, the ratio of R&D investment to operating income (referred to as "R&D expense ratio") decreased by 29.80 percentage points from the same period last year to 62.10%. According to the annual report, the company's R&D expenses in 2023 will be 12.813 billion yuan, a year-on-year increase of 14.90%. The company said it plans to actively expand the indication development of BRUKINSA and tisonan, and strengthen the development of pipeline products. "With the expansion of the scale of drug clinical trial R&D and the increasing demand of market business, we plan to continue to invest in the construction of R&D infrastructure in the future, further improve the accumulation of R&D platforms, and develop innovative drugs that are closer to the needs of customers according to the current market conditions." The company said.

Baili Tianheng's R&D expenses in the first quarter of this year were 249 million yuan, an increase of 56.52% from 159 million yuan in the same period last year. According to the annual report, the company's R&D expenses in 2023 will be 746 million yuan, a year-on-year increase of 98.98%. On May 7, the company was surveyed by nearly 190 institutions. Institutions are concerned about their drug research and development, and the six issues disclosed in the Investor Relations Activity Record Form are all related to it. Focusing on the hot track of ADC, Baili Tianheng was asked about the company's future development ideas for new ADC drugs, the selection strategy of targets and antibody sequences when developing ADC products, and the main advantages of the company's ADC products.

The sales of a number of innovative drugs exceeded 1 billion yuan

At present, domestic innovative drugs are gradually entering the harvest period. Looking back at 2023, the sales of a number of innovative drugs will exceed 1 billion yuan.

BeiGene, for example, has two blockbuster varieties with annual sales of more than $500 million. According to the company's U.S. stock performance report, in 2023, the global sales of BeiGene's core self-developed BTK inhibitor BRUKINSA will reach US$1.290 billion, a year-on-year increase of 128.5%; Its global sales of its PD-1 inhibitor tislelizumab were US$537 million, up 26.9% year-on-year. Wu Xiaobin, president and chief operating officer of the company, revealed in communication with investment institutions on May 9 that in the first quarter of this year, BAIKINSA's global sales reached 3.476 billion yuan, a year-on-year increase of 140.2%; The sales volume of Baizean totaled 1.044 billion yuan, a year-on-year increase of 32.8%.

In addition, Allist revealed in an institutional survey at the end of April that its core product fumetinib mesylate will achieve sales revenue of 1.978 billion yuan in 2023, Akeso Biopharma disclosed in its annual report that Ketanib will achieve sales of 1.358 billion yuan in 2023, Henlius' trastuzumab will achieve revenue of 2.737 billion yuan in 2023, and serplulimab will achieve revenue of 1.12 billion yuan.

Du Xiangyang, chief analyst of Southwest Securities Pharmaceutical, said that since the third quarter of last year, innovative drugs and preparations have been affected by the external environment, and the revenue of the sector in the second half of the year has declined slightly year-on-year, but benefiting from the reduction of the sales expense rate, the profitability has risen steadily, and the revenue of the sector in 2023 will be 348.8 billion yuan, a year-on-year increase of 4.6%, and the net profit attributable to the parent company will be 40.23 billion yuan, a year-on-year increase of 7.7%. Zhu Guoguang, an analyst at Soochow Securities, said that the overall revenue growth rate of the pharmaceutical industry is under pressure, but the structural differentiation is becoming more and more obvious, and the innovative drug industry chain, medical devices, biological products, etc. may become the main growth drivers of the industry.

Many institutions believe that driven by new productivity, innovation promotes industrial transformation and upgrading, and innovative drugs are expected to welcome the policy spring breeze, and are optimistic about the long-term development prospects of the innovative drug industry. "The 2024 government work report mentions that it is necessary to cultivate the development of innovative drug industry, strengthen the research and development and application of people's livelihood technologies such as health care for the elderly, and improve the ability of medical and health services, and emphasizes that the main tone of the development of the pharmaceutical industry in 2024 is innovation and development. Since then, many places, including Beijing, Guangzhou, and Zhuhai, have successively issued relevant policies to support the high-quality development of the biomedical industry or innovative drugs and devices. Everbright Securities said that it is firmly optimistic about the innovative drug industry chain, and innovation-driven is the main line of pharmaceutical investment in the future.

(Source: Economic Information Daily)