Weekly Pharma News Review | PharmaSources.com (April 11 to 15)

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 its Phase III clinical trials of hydromethylthionine mesylate (HMTM) (R&D code: TRx0237), an oral tau protein aggregation inhibitor, have been approved in China, and the proposed indications are mild to moderate Alzheimer's disease (AD), including mild cognitive impairment caused by AD. This research will be a supplement to HMTM's overseas Phase III clinical trials.

Breakthrough Therapy

11. On April 14, InxMed announced that IN10018, its focal adhesion kinase (FAK) inhibitor, has been listed as one of the breakthrough therapeutic drugs. It is based on the results of a Phase Ib/II clinical trial of IN10018 for platinum-resistant ovarian cancer, with the proposed indication for the treatment of platinum-resistant ovarian cancer in combination with PEG-liposomal doxorubicin.

FDA

Clinic

12. On April 11, Gilead announced that FDA has lifted the partial clinical hold for research of CD47 monoclonal antibody magrolimab in combination with azacitidine. The research of magrolimab combined with azacitidine in the treatment of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) can restore the work of patient enrollment.

13. On April 14, Haisco Pharmaceutical Group announced that FDA has approved its clinical trial application for HSK29116, and it will start the corresponding new drugs research and development in the United States. Independently developed by Haisco Pharmaceutical Group, HSK29116 is an oral PROTAC small molecule anti-tumor drug targeting BTK for controlling the progression of recurrent and refractory B-cell lymphoma. It is the first BTK-PROTAC drug in China and the second in the world to enter clinical research.

Orphan drug designation

14. On April 11, Keymed Biosciences announced that its product CMG901 has been granted the orphan drug designation by FDA for the treatment of advanced gastric cancer and adenocarcinoma of the gastroesophageal junction. CMG901 is an ADC targeting Claudin 18.2, which has been approved for clinical trials both in China and US. It has been approved by FDA to carry out Phase I clinical trials for advanced gastric cancer and adenocarcinoma of the gastroesophageal junction.

15. On April 13, Shanghai Junshi Biosciences announced that FDA has granted orphan drug designation (ODD) for PD-1 Toripalimab for the treatment of small-cell lung cancer (SCLC). This is the fifth orphan drug designation (ODD) granted to Toripalimab. Before this, it has been respectively granted orphan drug designation for treating mucosal melanoma, nasopharyngeal carcinoma, soft tissue sarcoma, and esophageal cancer.

R&D

Publication of clinical results

16. On April 11, BeiGene announced the final mitigation evaluation results of Alpine research, a global Phase III clinical trial of zanubrutinib. The Independent Review Committee (IRC) confirmed that zanubrutinib presents a higher overall response rate (ORR) than that of Ibrutinib in adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

17. On April 11, Veru announced that sabizabulin (bisindole) reduces the relative death risk of hospitalized patients with moderate and severe COVID-19 by 55%. On account of the good data, the Independent Data Monitoring Committee (IDMC) recommends terminating the clinical trials ahead of schedule. Veru plans to communicate with FDA in the near future for emergency use authorization (EUA).

Launching the clinical trials

18. On April 11, according to the drug clinical trial registration and information publicity platform of CDE, Salubris’s first-in-class new drug SAL0114, have been approved for the Phase I clinical trials with the indication of depression. SAL0114 is the so-called deuterium dextromethorphan tablet. Two indications of it have been approved for clinical trials, namely, severe depression and Alzheimer's disease agitation.

19. On April 14, according to the drug clinical trial registration and information publicity platform of CDE, Huadong Medicine initiated the BE trial of Olaparib and became the fourth Chinese competitive enterprise in the generic drug. Researched and developed by AstraZeneca, Olaparib is the first poly adenosine diphosphate-ribose polymerase (PARP) inhibitor approved for marketing worldwide and was approved in China in August 2018. Till now, two enterprises have presented marketing applications.

Business

20. On April 13, LENZ and Ji Xing Pharmaceuticals announced that they have entered into an exclusive license agreement about LNZ100 (aceclidine) and LNZ101 (aceclidine + brimonidine) for the treatment of presbyopia in Greater China. LENZ will receive advanced and milestone payments of up to $110 million, as well as royalty payments based on future net sales.

Listing

21. Hinova Pharma was officially listed in the STAR market on April 12. Hinova Pharma focuses on deuteration technology and PROTAC[RH4]  targeted protein degradation technology. Established in 2013, Hinova currently boasts 10 products under research,  4 of them have entered the clinical development stage, including an AR inhibitor, a URAT1[RH5]  inhibitor, a growth factor co-receptor CD44v6 inhibitor, and an oral AR PROTAC molecule.

Personnel changes

22. On April 12, Hengrui Medicine announced the resignation of  Chief Medical Officer (CMO) and Deputy General Manager Zou Jianjun. Zou has worked in Hengrui Medicine for more than 6 years since September 2015. Besides, Hengrui announced the appointment of Ms. Zhang Xiaojing as the company’s Deputy General Manager and Chief Medical Officer (Oncology).

Other

23. On April 11, the WHO issued a press release, suggesting that a single-dose HPV vaccine can effectively prevent cervical cancer. The WHO Strategic Advisory Group of Experts on Immunization (SAGE) evaluated the single dose of the vaccine and concluded that a single-dose HPV vaccination provides equivalent protection as a two-dose regimen against HPV. Affected by this, the stock price of Zhifei Biological plummeted by 18%, and that of Wantai Biological hits the limit down (-10%).

Reference

 [RH1]A recent report published in the World Health Organization (WHO) News Release suggested that a single dose of the human papillomavirus (HPV) vaccination confers equivalent immunity to a two-dose schedule against cervical cancers caused by HPV.

https://www.news-medical.net/news/20220414/Single-dose-vaccine-delivers-protection-against-cervical-cancer-causing-HPV-comparable-to-2-or-3-dose-regimes.aspx

 [RH2]https://uk.advfn.com/stock-market/share-news/Luye-Pharma-Grants-Exeltis-Exclusive-Commercializa/87716851

 [RH3]https://www.bayer.com/en/pharma/first-treatment-trk-fusion-cancer-approved

 [RH4]proteolysis-targeting chimera

 [RH5]Urate transporter 1