MSD's Quadrivalent HPV Vaccine Gains New Indication in China; AstraZeneca's AZD1222 Meets Primary Endpoint for COVID-19 Prevention

[November 23, 2020 / Pharmaceutical News Brief] MSD’s Quadrivalent HPV Vaccine Approved for New Indication; AstraZeneca Announces Its COVID-19 Vaccine Met Primary Efficacy Endpoint in Preventing COVID-19; Pfizer/BioNTech COVID-19 Vaccine Expected to Gain UK Approval This Week; Opdivo + Yervoy First-Line Therapy for Malignant Pleural Mesothelioma Proposed for Priority Review; Harbour BioMed Passes HKEX Listing Hearing... Stay tuned with Sudu She for daily fresh pharmaceutical and medical news!

Part 1 Policy Brief

Other pharmaceutical technicians may assume the responsibilities of licensed pharmacists.

On November 20, the National Medical Products Administration (NMPA) issued the "Notice on Regulating the Staffing and Utilization of Licensed Pharmacists in Pharmaceutical Retail Enterprises." The Notice clarifies that, in light of the current practical difficulties in certain regions characterized by shortages and staffing challenges for licensed pharmacists, provincial-level drug regulatory authorities may formulate and implement differentiated policies for the staffing and utilization of licensed pharmacists, provided that the existing overall staffing ratio of licensed pharmacists is not reduced. A transition period shall be established. During this transition period, in areas with significant shortages of licensed pharmacists, pharmaceutical retail enterprises are permitted to assign other pharmaceutical technical personnel to fulfill the responsibilities of licensed pharmacists. The transition period shall not extend beyond 2025. (National Medical Products Administration)

Tianjin Further Develops Community Health Services

Recently, the Tianjin Municipal Health Commission issued the "Decision on Further Developing Community Health Services (Revised Draft)." For medical graduates with a bachelor's degree or higher, general practitioners who have successfully completed standardized residency training, urgently needed and scarce professional technical personnel, and high-level talents with senior professional titles or doctoral degrees, recruitment procedures will be simplified. Public recruitment may be conducted through interviews and organizational assessments. The compensation distribution system will be reformed and optimized. Rural grassroots health institutions will gradually transition into urban community health service institutions. Construction of standardized general practice outpatient clinics in community health service institutions has been launched. (Tianjin Municipal Health Commission)

Part 2 Industry and Economic Observation

Lilly and Precision Reach Collaboration

On November 20, Eli Lilly and Precision BioSciences announced a research collaboration and exclusive licensing agreement, under which Eli Lilly will utilize Precision’s proprietary ARCUS^®Genome editing platform for the research and development of potential in vivo therapies for genetic diseases, with a focus on Duchenne muscular dystrophy and two other undisclosed gene targets. (Sina Medical News)

Novartis and Mesoblast Enter into Collaboration

Novartis and Mesoblast Sign Global Exclusive Licensing Agreement for Remestemcel-L, an Allogeneic Mesenchymal Stem Cell Therapy for Acute Respiratory Distress Syndrome (ARDS), Including ARDS Associated with COVID-19 (Sina Medical News)

Harbour BioMed Passes HKEX Listing Hearing

On November 22, the information disclosed on the Hong Kong Stock Exchange website showed that Harbour BioMed's IPO application had passed the hearing by the Hong Kong Stock Exchange. According to the post-hearing information package, the funds raised in this IPO will mainly be used for the clinical development of the company’s core products, the advancement of its innovative product pipeline, and the continuous enhancement of its antibody technology platform. (Yiyao Guanlan)

Part 3 Pharmaceutical News

Pfizer/BioNTech COVID-19 Vaccine May Be Approved in the UK This Week

The COVID-19 vaccine developed by Pfizer and BioNTech could receive approval from UK regulators as early as this weekend. Clinicians have been advised to be prepared for the vaccine’s arrival by December 1. According to UK media reports, under a “best-case scenario,” the UK medicines regulator may reach a decision within a week, and the National Health Service (NHS) could be ready to begin distributing the vaccine before December 1. (Sina Pharmaceutical News)

MSD’s Keytruda Submits New Indication Marketing Application in China and Is Accepted

Today, the Center for Drug Evaluation (CDE) website announced that Merck Sharp & Dohme’s PD-1 inhibitor pembrolizumab injection (Keytruda) has submitted a new indication marketing application, which has been accepted. To date, Merck Sharp & Dohme has submitted a total of seven marketing applications for pembrolizumab injection in China. Among these, the first five marketing applications have all been approved in China. (Yiyao Guanlan)

BMS Opdivo Combined with Yervoy for First-Line Treatment of Malignant Pleural Mesothelioma Proposed for Priority Review

Today, the CDE website announced that the combination therapy of Bristol Myers Squibb’s PD-1 inhibitor nivolumab and CTLA-4 antibody ipilimumab is proposed to be included in the priority review as a “drug eligible for conditional approval.” The proposed indication is for the treatment of adult patients with previously untreated, unresectable, non-epithelioid malignant pleural mesothelioma. (Yiyao Guanlan)

AstraZeneca Announces Its COVID-19 Vaccine Meets Primary Efficacy Endpoint for Preventing COVID-19

Today, AstraZeneca announced that high-level positive results from the interim analysis of the AZD1222 clinical trials conducted in the UK and Brazil showed that the vaccine is highly effective in preventing COVID-19 (primary endpoint), with vaccine efficacy rates of 90% and 62% for the two dosing regimens, respectively. No hospitalizations or severe cases were reported among vaccinated participants. (Immediate Pharma News)

MSD’s Quadrivalent Human Papillomavirus Vaccine Approved for New Indications in China

Today, MSD announced that its quadrivalent human papillomavirus (HPV) vaccine has received marketing approval from the National Medical Products Administration for use in females aged 9 to 19 years. This means the vaccine is now indicated for females aged 9 to 45 years, with the three-dose immunization schedule remaining unchanged. (Immediate Pharma News)

Gilead’s Oral JAK1 Inhibitor Jyseleca Launched in Japan

Gilead Sciences Japan and its partner Eisai recently announced the launch of Jyseleca in Japan. This novel, once-daily oral selective JAK1 inhibitor was approved by the Japanese Ministry of Health, Labour and Welfare this September for the treatment of adult patients with rheumatoid arthritis who have had an inadequate response to conventional therapies, including for the prevention of structural joint damage. (Sina Medical News)

Tonghua Dongbao's Ultra-Rapid-Acting Insulin Lispro Injection Approved for Clinical Trials

Today, Tonghua Dongbao announced that its drug registration application for the ultra-rapid-acting insulin lispro injection (THDB0206) had recently received a Notice of Approval for Clinical Trials from the National Medical Products Administration. (Sina Pharmaceutical News)

Lepu Hengjiuyuan Pharmaceutical's Betahistine Hydrochloride Tablets Become the First to Pass Quality Consistency Evaluation

Today, the official website of the National Medical Products Administration (NMPA) announced that Lepu Hengjiuyuan Pharmaceutical’s supplemental application for the consistency evaluation of Betahistine Hydrochloride Tablets has been approved. Data from Menet shows that sales of betahistine tablets at public medical institutions in China reached nearly RMB 400 million in 2019, with a year-on-year growth of over 10% in the first half of this year. (Menet)

Qianjin Xiangjiang Pharmaceutical’s Difenidol Hydrochloride Tablets Receive First Generic Drug Consistency Evaluation Approval

Today, the official website of the National Medical Products Administration (NMPA) announced that the supplemental application for the consistency evaluation of Hunan Qianjin Xiangjiang Pharmaceutical’s Difenidol Hydrochloride Tablets has been approved. Data from Menet shows that in the first half of this year, sales of difenidol tablets at the terminal level of public medical institutions in China increased by more than 30% year-on-year. (Menet)

Innovent Biologics Announces Results from Phase III Clinical Study of Tyvyt Combined with Byvasda as First-Line Treatment for Advanced Liver Cancer

On November 21, Innovent Biologics announced that the clinical study results of ORIENT-32 were presented as a preferred oral report at the ESMO Asia online conference. Compared with the control group, Tyvyt^®(Sintilimab Injection) in Combination with Byvasda^®(Bevacizumab Injection) First-line Treatment for Advanced Hepatocellular Carcinoma Reduces Risk of Death by 43.1% and Risk of Disease Progression by 43.5%. This Combination Therapy Significantly Prolongs Overall Survival and Progression-Free Survival, Meeting Prespecified Superiority Criteria. (PR Newswire)

CStone Pharmaceuticals Announces Detailed Results from Clinical Study of Sugemalimab in Combination with Chemotherapy

On November 21, CStone Pharmaceuticals presented the detailed results of the GEMSTONE-302 study for the first time in an oral presentation at the ESMO Asia 2020 virtual annual meeting. The results showed that sugemalimab combined with chemotherapy significantly prolonged investigator-assessed progression-free survival compared to placebo combined with chemotherapy as first-line treatment for advanced non-small cell lung cancer. (PR Newswire)

Zai Lab’s $176 Million Licensed ROS1/TRK-Targeted Therapy Approved for Clinical Trials

CDE Public Notice Shows That Repotrectinib Capsules, a Class 1 New Drug Jointly Submitted by Turning Point and Zai Lab, Received an Implied Clinical Trial Approval, Intended for the Treatment of Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements. In July this year, Zai Lab obtained exclusive development and commercialization rights for this investigational drug in Greater China for $176 million. (Medical Insight)

NMPA Revises the Package Inserts of Xinnaokang Preparations

On November 20, the National Medical Products Administration (NMPA) issued the "Announcement of the National Medical Products Administration on Revising the Package Inserts of Xinnaokang Preparations (No. 127 of 2020)." The announcement indicated that the revisions primarily involved adding information on adverse reactions, contraindications, and precautions to the package inserts of Xinnaokang preparations. (Sina Pharmaceutical News)

AbbVie's Venetoclax Tablets Enter Administrative Approval Phase

On November 20, the marketing application for AbbVie’s BCL-2 inhibitor, Venclexta (venetoclax tablets), entered the administrative approval phase, indicating that the drug is imminent to be approved in China. The approved indication is: in combination with azacitidine, decitabine, or low-dose cytarabine for the treatment of newly diagnosed adult patients with acute myeloid leukemia (AML) who are aged 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy. (CPhI Pharma Online)

Huadong Pharmaceutical’s Caspofungin Acetate for Injection Approved for Market Launch

Recently, the official website of the National Medical Products Administration (NMPA) announced that Huadong Pharmaceutical’s novel echinocandin antifungal drug, caspofungin acetate for injection, has been approved for market launch. Data from Menet shows that sales of caspofungin injections at public medical institutions in China exceeded RMB 2 billion in 2019, with a slight year-on-year decline in the first half of this year. (Menet)

Two Consecutive Articles in Prestigious Journals Confirm the Efficacy and Safety of Zanubrutinib

Recently, the prestigious journal Blood published two articles in succession, announcing the 3-year follow-up data of zanubrutinib in the treatment of Waldenström macroglobulinemia and comparing its efficacy with ibrutinib, confirming that zanubrutinib demonstrates superior clinical efficacy and a better safety profile. (CPhI Online)