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 3, 2022 to January 9, 2022, the drug evaluation center (CDE) of the State Drug Administration received 10 applications for new chemical drugs and therapeutic biological products submitted by 9 listed companies (including the holding company of listed companies).
One week new drug application
In terms of listed companies this week, Jiangsu Hengrui Medicine Co.Ltd(600276) (600276, SH) applied for two clinical applications, Pharmaron Beijing Co.Ltd(300759) (300759, SZ), Baiji Shenzhou (06160, HK), zaiding medicine (09688, HK), Fuhong Hanlin (02696, HK), Deqi medicine (06996, HK), Changchun High And New Technology Industries (Group) Inc(000661) (000661, SZ), Tonghua Dongbao Pharmaceutical Co.Ltd(600867) (600867, SH), Shenzhen Chipscreen Biosciences Co.Ltd(688321) (688321, SZ) applied for one clinical application each.
One week hot review
\u3000\u3000 1。 Fuhong Hanlin PD-L1 / tigit double antibody injection is the third in China
On January 6, CDE’s official website showed that Fuhong Hanlin’s clinical application for PD-L1 / tigit dual antibody injection hlx301 was accepted, which is also the second dual antibody drug applied for clinical application by the company. In November 2021, the company’s clinical application for dual anti drug hlx35 targeting 4-1BB / EGFR was accepted.
Hlx301 is an innovative anti-PD-L1 and anti tigit bispecific antibody independently developed by the company, which is intended to be used in the treatment of a variety of advanced solid tumors. Fuhong Hanlin previously announced that the tigit binding domain of hlx301 comes from the VHH fragment with high affinity and high specificity for tigit screened by the company’s humanized Alpaca heavy chain variable region single domain antibody (VHH) phage display library; The results of preclinical studies show that hlx301 can specifically bind to human PD-L1 and tigit, block the binding of PD-1 / PD-L1 and tigit / PVR, and cut off the negative signals downstream of PD-1 and tigit, which can inhibit the growth of tumor, with good tolerance and safety. In November 2021, hlx301 was approved for clinical use in Australia.
industry insight:
it is understood that the hlx301 of Fuhong Hanlin is the third PD-L1 / tigit dual anti drug to be applied for clinical application in China. on November 26, 2021, CDE’s official website showed that the pm1022 injection clinical application of pumice Biotechnology (Zhuhai) Co., Ltd. was accepted, becoming the first PD-L1 / tigit dual antibody to apply for clinical application in China. Then, the PD-L1 / tigit double anti drug sh006 injection of Nanjing Shenghe Pharmaceutical Co., Ltd. was also applied for clinical application in December 2021. In just two months, three drugs were applied for clinical application one after another, and the competition for research and development of PD-L1 / tigit dual antibody intensified.
Public data show that tigit blocker has the prospect of treating a variety of advanced tumors, including non-small cell lung cancer, gastric cancer, melanoma and multiple myeloma. It is another popular target in addition to popular targets such as PD-1, PD-L1 and CD47. Globally, there is no anti tigit drug on the market, but the tigit monoclonal antibody / double antibody drugs developed by many enterprises at home and abroad have entered the stage of clinical trial.
According to the data of Yaodu, at present, Chinese pharmaceutical enterprises have applied for clinical application of six tigit monoclonal antibodies, namely ibi939 of Xinda biology, bgb-a1217 of Baiji Shenzhou, Shanghai Junshi Biosciences Co.Ltd(688180) js006, Bio-Thera Solutions Ltd(688177) bat6021 and bat6005, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) hb0030. Except bgb-a1217 of Baiji Shenzhou is in phase III clinical, other drugs are in phase I clinical. In addition, there are two PD-1 / tigit dual anti drugs for clinical application in China, namely ibi321 of Cinda biology and zg005 of Suzhou Zelgen Biopharmaceuticals Co.Ltd(688266) .
Source: Yaodu database
company comments:
Fuhong Hanlin started with biological analogues and has successfully listed four biological analogues, including the first domestic biological analogues rituximab, the first domestic monoclonal antibody biological analogues trastuzumab, adalimumab and bevacizumab in China and Europe. From 2018 to 2020, Fuhong Hanlin has accumulated a loss of more than 2.3 billion yuan in three years. In 2020, the company made a breakthrough in commercialization. After the commercialization of rituximab, trastuzumab and adalimumab, the sales increased rapidly. In the first half of 2021, the company achieved a revenue of 634 million yuan, a year-on-year increase of about 474%.
With Fuhong Hanlin’s many biological similar drugs with competitive advantages successively entering the commercialization and large-scale stage, the company’s performance is expected to continue to grow, and overweight innovative drugs have become the strategic focus of the company. The listing application of the company’s heavy PD-1 product Sullivan has been included in the priority review by CDE and is expected to be officially listed in 2022. As of December 2021, the company still has a number of innovative drug products at different clinical stages.
Source: Official Website of the company
researchers of nuggets innovative medicine believe that tigit will be another hot target in recent years after PD-1, PD-L1 and CD47 have become hot targets. At present, tigit drugs have not been approved for marketing all over the world, and the market potential is huge ; Judging from the time of clinical application, the hlx301 of Fuhong Hanlin is not too late and is in the first echelon of PD-L1 / tigit dual anti drug research and development in China, but it is still unknown who can take the lead. As the clinical application of the drug has just been accepted, there are many uncertainties in the future test results. If the clinical trial can be successfully completed and listed in the future, it is expected to support the continuous growth of the company’s performance.
\u3000\u3000 2。 Shenzhen Chipscreen Biosciences Co.Ltd(688321) cioroni capsule is intended to treat soft tissue sarcoma and is applying for phase II clinical trial. It is promoting multiple indication clinical trials
On January 5, Shenzhen Chipscreen Biosciences Co.Ltd(688321) announced that the company’s application for phase II clinical trial of theoroni capsule was accepted, and the indications were patients with advanced or unresectable soft tissue sarcoma who failed the standard treatment. Theoroni is a new chemical structure with global patent protection independently designed and developed by the company. It is a multi-target multi-channel selective kinase inhibitor.
Theoroni is an original small molecule antitumor drug, which can selectively inhibit Aurora B, csf1r, VEGFR / PDGFR / c-kit and other kinase targets. According to the company, theoroni realizes the anti-tumor efficacy of multi-channel mechanism through three active mechanisms of inhibiting tumor cell mitosis, inhibiting tumor angiogenesis and regulating tumor immune microenvironment, so as to play a comprehensive anti-tumor effect. It has better animal pharmacodynamic activity and good safety than similar mechanism drugs.
The company also said that preclinical studies suggest that cioroni has potential therapeutic value as a multi-target and multi-channel selective kinase inhibitor for soft tissue sarcoma.
industry insight:
It is understood that soft tissue sarcoma (STS) is a malignant tumor derived from non epithelial extraosseous tissue. It can occur at any age and all parts of the body, accounting for about 1% of all malignant tumors. It is a rare tumor. At present, local treatment methods such as surgery and radiotherapy have achieved some success in soft tissue sarcoma, but most of them have the risk of recurrence and metastasis. The systematic treatment options available clinically are mainly chemotherapy drugs. For patients with advanced STS, the role of systemic treatment is limited, and the clinical response rate is no more than 50%. There is still an urgent need for new therapeutic drugs.
In July 2019, Zhengda Tianqing announced that it had obtained the drug registration approval of arotinib hydrochloride capsule for the treatment of soft tissue sarcoma, and arotinib became the first approved targeted drug for soft tissue sarcoma in China. Previously, arotinib was awarded the qualification of orphan drug for the treatment of soft tissue sarcoma by FDA in June 2017. In September 2020, Shanghai Junshi Biosciences Co.Ltd(688180) treprizumab was recognized as an orphan drug by FDA for the treatment of soft tissue sarcoma.
In addition to soft tissue sarcoma, theoroni has also carried out clinical trials of multiple tumor indications. At present, cioroni is carrying out phase III clinical trials of single drug treatment of small cell lung cancer and combined paclitaxel treatment of ovarian cancer, as well as different stages of research on multiple indications such as liver cancer, lymphoma and other neuroendocrine tumors. cioroni’s clinical research on small cell lung cancer and ovarian cancer has been included in the “breakthrough treatment” by CDE. In addition, the phase Ib / II clinical trial of cioroni in the treatment of small cell lung cancer is being promoted in the United States, and has been granted orphan drug qualification by FDA in September 2021.
company comments:
Shenzhen Chipscreen Biosciences Co.Ltd(688321) is the “first share of innovative drug enterprises” on the science and innovation board. In August 2019, Shenzhen Chipscreen Biosciences Co.Ltd(688321) successfully landed on the science and innovation board. Over the past 20 years since its establishment, Shenzhen Chipscreen Biosciences Co.Ltd(688321) at present, class 1 original new drugs in two countries have been approved for listing. The company’s west side is the first drug approved for treatment of peripheral T cell lymphoma in China. The approval of breast cancer indication has made the adaptation range of CB from blood tumor to solid tumor. Sida benamine is also the company’s main commercial product, with a sales revenue of 245 million yuan in 2020, contributing more than 90% to the company’s revenue.
In the first three quarters of 2021, Shenzhen Chipscreen Biosciences Co.Ltd(688321) achieved a revenue of 277 million yuan, a year-on-year increase of 48.61%, and the net profit attributable to the parent company was – 24.25 million yuan, a year-on-year decrease of 163.12%. The company said that it was mainly due to the significant increase in R & D expenses and sales expenses. In 2019 and 2020, the company’s R & D investment accounted for 45.02% and 50.94% of revenue respectively. In October 2021, Shenzhen Chipscreen Biosciences Co.Ltd(688321) was marketed as an indication of type 2 diabetes, and the market for diabetes was broad. The company’s performance is expected to continue to grow.
Researchers of nuggets innovative drugs believe that as Shenzhen Chipscreen Biosciences Co.Ltd(688321) another blockbuster new drug following sidabelamine and ciglitazidine sodium, at present, sioroni is promoting multiple clinical trials of indications at the same time, among which the indications for the treatment of small cell lung cancer and ovarian cancer are expected to be first approved for listing; If the clinical trial of theoroni in the treatment of soft tissue sarcoma progresses smoothly, it may further expand theoroni’s market imagination and improve the company’s performance flexibility.
