The sharp crushing in the stock prices of Chinese vaccine leader companies Zhifei Biological and Wantai Biological is the most-watched news this week. It arises from the WHO press release [RH1] on the solid protection of a single-dose HPV vaccination against cervical cancer. The Weekly Pharma News Review of this week contains 23 pieces of news covering the following sections: drug review, R&D, business, listing, personnel changes, and other information.
Drug Review
NMPA
Marketing Application
1. On April 11, CDE's official website revealed the new indication of Henlius’s PD-1 serplulimab has been declared for marketing, which is expected to be the first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC). This is the third indication applied for Serplulimab. It has just been approved as the single-drug therapy for the treatment of the microsatellite instability-high (MSI-H) solid tumor, which is unresectable and metastatic after the failure of standard therapy.
2. On April 12, Luye Pharma announced that CDE has accepted the marketing application of Rivastigmine Transdermal Patch (LY03013) [RH2] for treating mild to moderate dementia associated with Alzheimer's disease. LY03013 is an improved patch formulation of Rivastigmine which is administered twice a week through the skin. The drug has been earlier licensed for marketing in many European countries and regions.
Approval
3. On April 11, Pfizer's Abrocitinib is approved for marketing by NMPA for adult patients with refractory and moderate-to-severe atopic dermatitis who have a poor response to other systematic treatments (such as hormones or biological agents) or are not suitable for the above treatments. This is the fifth JAK inhibitor innovative drug marketed in China.
4. On April 13, a new indication of BeiGene PD-1 Tislelizumab is approved for the treatment of locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) patients who have advanced or intolerable after receiving first-line standard chemotherapy. This is the eighth indication of Tislelizumab approved in China.
5. On April 13, the marketing application for the fifth indication of Chiatai Tianqing’s Anlotinib Hydrochloride Capsules is approved, which is presumed to be the differentiated thyroid cancer. Initially getting marketed in May 2018, the drug has been approved for the treatment of four indications, including advanced non-small cell lung cancer, soft tissue sarcoma, small cell lung cancer, and medullary thyroid cancer.
6. On April 13, Bayer's Larotretinib Capsule is approved for marketing. It is for the treatment of adults and children with solid tumors carrying the neurotrophin tyrosine receptor kinase (NTRK) [RH3] fusion gene. Initially discovered by ArrayBioPharma, Larotretinib is the first-generation TRK inhibitor and the first biomarker-based drug to market.
7. On April 13, the new indication of Novartis’s omalizumab is approved, which is presumed to treat chronic spontaneous urticaria (CSU) refractory to antihistamines. Omalizumab is a recombinant humanized monoclonal antibody and an anti-IgE targeting biological agent, which is approved initially in China in August 2017.
Clinic Approval
8. The CDE official website revealed that, on April 11, BeiGene's Tislelizumab and Ociperlimab combination therapy is approved for clinical trials for adjuvant and neoadjuvant treatment of non-small cell lung cancer (NSCLC). Ociperlimab is an anti-TIGIT monoclonal antibody independently developed by BeiGene, which has entered Phase III clinical development.
9. On April 12, Betta Pharmaceuticals announced that the new indication of ensartinib hydrochloride is approved for clinical trials in the postoperative adjuvant treatment of ALK-positive non-small cell lung cancer (NSCLC). Developed by Betta Pharmaceuticals, ensartinib is the only Chinese ALK inhibitor approved for marketing currently. Up to now, two indications of ensartinib have been approved, which are the second-line treatment of ALK-positive locally advanced or metastatic NSCLC and the first-line treatment of ALK-positive NSCLC.
10. On April 13, TauRx announced that i...
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