Nuggets innovative medicine is jointly launched by the daily economic news and Yaodu data. It aims to interpret the progress and trend of new drug research and development, analyze product competitiveness and market prospects, gain insight into the context of pharmaceutical capital, and witness the high-quality development of the pharmaceutical industry.
According to the data of Yaodu, from January 17 to 21, 2022, the drug evaluation center (CDE) of the State Drug Administration received 17 applications for new chemical drugs and therapeutic biological products submitted by 10 listed companies.
One week new drug application
In terms of listed companies this week, Jiangsu Hengrui Medicine Co.Ltd(600276) (600276. SH) submitted two clinical applications and one production application; Sichuan Kelun Pharmaceutical Co.Ltd(002422) (002422. SZ) applied for 3 clinical applications in total, Xinda Biology (01801. HK), Brightgene Bio-Medical Technology Co.Ltd(688166) (688166. SH), Zhengda Tianqing under China biopharmaceutical (01177. HK) applied for 2 clinical applications each, Zhejiang Medicine Co.Ltd(600216) (600216. SH), Shandong Buchang Pharmaceuticals Co.Ltd(603858) (603858. SH), conoya-b (02162. HK), Shenzhen Neptunus Bioengineering Co.Ltd(000078) (000078. SZ) applied for 1 clinical application each; Haisco Pharmaceutical Group Co.Ltd(002653) (002653. SZ) apply for one production application
note: the declarations of different specifications of the same drug of the same company are not listed separately in the above table
Hot review week
1. Her2-adc drugs have entered the intensive harvest period. Can arx788 help Zhejiang Medicine Co.Ltd(600216) successfully transform ?
On January 21, the official website of CDE showed that the clinical application of recombinant humanized anti-HER2 monoclonal antibody as269 conjugate (arx788) for injection of new code biology of Zhejiang Medicine Co.Ltd(600216) subsidiary was accepted.
The recombinant humanized anti HER2 monoclonal antibody -AS269 coupling injection is a new generation of monoclonal antibody conjugated drugs developed by Zhejiang Medicine Co.Ltd(600216) in June 14, 2013 with the signing of the cooperative development and license agreement with Ambrx company. It is used for the treatment of HER2 positive advanced breast cancer and gastric cancer.
According to the cooperation agreement reached between Zhejiang Medicine Co.Ltd(600216) and ambrx company, Zhejiang Medicine Co.Ltd(600216) has the commercial development right of arx788 in China. After the licensed products are listed and sold in China, ambrx company will withdraw the equity fund according to the proportion of no more than 20% of the net sales.
In terms of efficacy and safety, the 2020 CSCO conference released phase I clinical data of ARX788 treatment for HER2 positive breast cancer patients: the objective response rate (ORR) of the 1.5mg treatment group was 68.4%, and the disease control rate (DCR) was 100%. The orr of patients who failed to receive TKI treatment in the past was 44.7%, and the safety was good.
In terms of research and development progress, arx788 was included in the breakthrough treatment variety by CDE in May 2021, and was approved to carry out phase II / III clinical trial for the treatment of gastric cancer and gastroesophageal junction adenocarcinoma in February 2021. as of press release, ARX788's II/III phase of clinical research is said to have come to an end. It is expected that a single drug treatment for HER2 positive breast cancer will be available in 2022.
industry insight:
Due to its good targeting and anticancer activity, antibody coupled drugs (ADC) have become a new hotspot and important trend in drug research and development in the field of cancer, and are receiving more and more attention.
according to the data of Yaodu, by the time of publication, two her2-adc drugs had been approved for marketing in China , including an imported drug, emmettrastuzumab (kadcyla, t-dm1) of Roche pharmaceutical; In 2021, the her2-adc drug of Rongchang Biology - vidicizumab (rc48) was approved for marketing, marking the birth of domestic ADC drugs; there are four in the clinical phase III stage, including AstraZeneca and enhertu of the first three companies, taa-013 of Dongyao pharmaceutical, Bio-Thera Solutions Ltd(688177) bat-8001 and Zhejiang Medicine Co.Ltd(600216) arx-788. in addition, there are 14 drugs in clinical phase I / II stage , including well-known pharmaceutical enterprises such as Jiangsu Hengrui Medicine Co.Ltd(600276) , stone Pharmaceutical Group, Sichuan Kelun Pharmaceutical Co.Ltd(002422) , Sunshine Guojian Pharmaceutical(Shanghai) Co.Ltd(688336) .
From the market and application data, her2-adc drugs have entered an intensive harvest period. From the perspective of target trend, HER2 target is the most widely distributed ADC field in China, followed by Trop-2, CMET, EGFR, CD20, etc. given that about one-third of ADC drugs in China target HER2, it is expected that ADC drugs at this target will face a more fierce competition pattern, and its degree of involution in R & D progress is no less than PD-1 / PD-L1.
company comments:
In a research report, the securities firm said that if the new breast cancer patients in China were 278 thousand and 900 cases, the proportion of HER2 positive was 25%, the disease progression or drug resistance ratio was 50%, ARX788 reached 30% market share and the drug price was 100 thousand yuan / year, the peak value of ARX788 sales was expected to reach 1 billion 47 million yuan.
The production and commercialization of arx788 are also progressing steadily, Zhejiang Medicine Co.Ltd(600216) announced on December 30, 2021 that it plans to invest 620 million yuan to build an industrialization project with an annual output of 600000 bottles of recombinant humanized anti-HER2 monoclonal antibody-as269 coupling preparation. It is reported that Zhejiang Medicine Co.Ltd(600216) plans to start the design in early 2022, pile driving in the third quarter of 2022, and trial production is expected to be completed by the end of 2024. After the trial production is completed, the GMP certification will be applied. It is expected that the GMP certification will be completed in early 2026 and officially put into operation after passing the certification.
researchers from the Nuggets innovation group believe that ADC class antibody drugs can expand the indications of other cancer species and the treatment of other diseases based on the improvement of target and antibody technology in the fields of bladder cancer, hematoma and breast cancer. The future of ADC drug market is huge. at the company level, Zhejiang Medicine Co.Ltd(600216) as the main production base of fat soluble vitamins, anti drug resistant antibiotics and quinolone antibiotics in China, its pharmaceutical business is also transforming and upgrading from API to innovative drugs and high-end preparations. At the same time, the IPO of its subsidiary, xincode biotechnology innovation board, is also under planning, and investors pay sustainable attention.
2, Jiangsu Hengrui Medicine Co.Ltd(600276) adebailimab is the fifth domestic PD-L1
On January 24, Jiangsu Hengrui Medicine Co.Ltd(600276) announced that the subsidiary Shanghai Shengdi Pharmaceutical Co., Ltd. received the acceptance notice issued by the State Food and drug administration, and the application for drug marketing license of adebailimab injection (shr-1316) submitted by the company was accepted by the State Food and drug administration.
Adebailimab is a humanized anti-PD-L1 monoclonal antibody independently developed by Jiangsu Hengrui Medicine Co.Ltd(600276) . It can block the PD-1 / PD-L1 pathway leading to tumor immune tolerance by specifically binding to PD-L1 molecules, reactivate the anti-tumor activity of the immune system, and achieve the purpose of tumor treatment. Up to now, about 274 million yuan has been invested in the research and development of projects related to adebailimab injection.
industry insight:
Yaodu data show that up to now, there are 12 PD-1 / PD-L1 listed in China, including 6 domestic PD-1, 2 domestic PD-L1 (Corning Jerry's nvolizumab and cornerstone pharmaceutical's shuglizumab), 2 imported PD-1 and 2 imported PD-L1 (Roche's atilizumab and AstraZeneca's duvalizumab). including Shouke zulizumab of Zhaoke pharmaceutical and taitelimab of Sichuan Kelun Pharmaceutical Co.Ltd(002422) , Jiangsu Hengrui Medicine Co.Ltd(600276) adebailimab is a domestic PD-L1 monoclonal antibody declared for listing in paragraph 5. In addition, there are 60, 44 and 17 drugs in clinical phase I, II and III respectively, covering multiple molecular types such as monoclonal antibody, double / multi antibody and small molecule.
company comments:
Researchers of nuggets innovative medicine believe that in the past 2021, Jiangsu Hengrui Medicine Co.Ltd(600276) is in a critical period of transformation of innovative drugs. On the one hand, with the normalization of centralized procurement and the decline of generic drug sales, the growth rate of the company's performance slowed down. Especially in the third quarter of last year, its net profit showed the first negative growth since its listing, and its share price also fell all the way from the highest point at the beginning of the year, almost halving; on the other hand, Jiangsu Hengrui Medicine Co.Ltd(600276) now has 10 innovative drugs in hand, and more than 50 new drugs are being developed. With the acceptance of adebailey's listing application, the number of innovative drugs listed or declared for listing by the company has reached 4 in the past month alone, which fully proves that the output rhythm of R & D achievements of Jiangsu Hengrui Medicine Co.Ltd(600276) is still accelerating.
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According to Sinolink Securities Co.Ltd(600109) , the proportion of innovative drug revenue of Jiangsu Hengrui Medicine Co.Ltd(600276) has increased from 34% in 2020 to about 40% in the first half of 2021. By the end of 2021, all eight innovative drugs of Hengrui will be included in the national medical insurance catalogue. With the continuous listing of innovative drugs in the pipeline and the continuous expansion of indications, it is expected that Hengrui innovative drugs will gradually usher in the harvest period.
