1. The application for clinical trial of Junshi biological anti-TIGIT monoclonal antibody injection was accepted by FDA in the United States.
On January 28th, Junshi Biology announced that its subsidiary, Topaele, submitted a specific anti-TIGIT monoclonal antibody injection to FDA of the United States, which was accepted for clinical trials in the treatment of advanced malignant tumors.
TIGIT is a common inhibitory receptor of emerging NK cells and T cells. Preclinical tests have shown that anti-TIGIT antibodies and anti-PD-1/PD-L1 antibodies can play a synergistic anti-tumor effect. The combination of the two is a promising anticancer therapy strategy, which is expected to increase the response of patients to immunotherapy and expand the range of potential beneficiaries. At present, no similar target products have been approved to be listed at home and abroad.
2. Bartolizumab, a product under development by Platinum Medicine, has been awarded the qualification of breakthrough therapeutic drug by CDE.
On January 28th, Heplatinum Pharmaceutical-B announced that the company is developing full-human monoclonal antibodies (mAb) against Bartolizumab for the treatment of myasthenia gravis, which has recently been granted a breakthrough drug qualification by the Drug Evaluation Center of the State Drug Administration ("CDE").
Studies have also shown that bartolizumab is the first anti-FcRn target drug that has been shown to continuously reduce IgG after subcutaneous injection (SC) in Chinese and Caucasian populations.
3. The SHR0302 of Hengrui Medicine has been included in the quasi-breakthrough treatment variety.
The SHR0302 tablets of Ruishi Biology, a subsidiary of Heng Rui Pharmaceutical, were recently included in the public list of proposed breakthrough treatment varieties by the CDE of the Drug Evaluation Center of the State Drug Administration.
SHR0302 is a highly selective JAK1 inhibitor for the treatment of moderate and severe atopic dermatitis in adolescents and adults aged 12 and above. SHR0302 is the world's first oral JAK1 inhibitor for the treatment of atopic dermatitis.
4. CANSINOBIO-B expects a net loss of 400 million to 430 million yuan in 2020.
CANSINOBIO-B issued an announcement on January 28th. According to the company's preliminary estimates, the net loss attributed to the owner of the parent company for the year ending December 31, 2020 is expected to be RMB400m to RMB430 million, an increase of 155.1 per cent to 174.3 per cent compared with the same period last year.
The net loss after deducting non-recurring gains and losses attributed to the owner of the parent company is expected to be RMB 510 million to RMB 540 million in 2020, an increase of 192.4 per cent to 209.6 per cent compared with the same period last year.
The main reasons for the performance changes in this period are as follows: 1) the research and development cost has increased significantly to promote the research and development progress of adenovirus vector recombinant novel coronavirus vaccine; 2) the cash management income of government subsidies and idle fund-raising funds has increased.
5. The effectiveness of Novavax COVID-19 vaccine in South Africa trial is only 60%.
Novax announced on the morning of January 29th that its new version of COVID-19 vaccine has conducted phase Ⅱ clinical trials on more than 15000 subjects in the UK. Data show that the effectiveness of the vaccine is 89.3%.
It was found that the vaccine still had immune effect on the mutant strain B.1.1.7 prevalent in the United Kingdom. However, the results of Novavax's second trial in South Africa showed that the vaccine was less effective-only 60%, and that the mutated spike protein carried by the South African mutant B.1.351 had changed the status quo, making it more difficult for the vaccine to recognize the virus.
The Novak COVID-19 vaccine was granted fast-track status by the US FDA in November 2020 and is expected to be approved for market in April 2021.
Hong Kong stocks and pharmaceutical stocks rose collectively on Friday. Affected by the market, the early pharmaceutical stocks a sharp pullback. Pharmaceutical stocks with better fundamentals rebounded strongly today.
Risk hint: a new round of drug collection will be opened in 2021 to avoid drug companies within the scope of drug collection as far as possible.