China's First Domestic HPV Vaccine Available for Booking in May; Takeda's ADC Drug Set for Approval

[April 26, 2020 / Pharmaceutical News Overview]Hubei Announces Results of Centralized Procurement for COVID-19 Testing Reagents: Six Companies Selected; Takeda Divests Multiple European Assets for $670 Million; Zhifei Biological's Class 1 Novel Drug, Recombinant Mycobacterium tuberculosis Fusion Protein, Approved for Market Launch; New HER2+ Breast Cancer Drug "Neratinib Tablets" Expected to Gain Approval in China Soon...Daily Fresh Pharmaceutical and Medical News: SpeedRead Society Joins You in Paying Close Attention!

Part 1 Policy Brief

As of 24:00 on April 25, there were 694 existing confirmed cases of imported infections.

From 0:00 to 24:00 on April 25, 31 provinces (autonomous regions and municipalities directly under the Central Government) and the Xinjiang Production and Construction Corps reported 11 newly confirmed cases, including 5 imported cases and 6 domestic cases (5 in Heilongjiang Province and 1 in Guangdong Province). There were currently 694 imported confirmed cases (including 22 severe cases) and 10 suspected cases. The cumulative number of confirmed cases was 1,634, with 940 patients discharged after recovery and no deaths. (Official website of the National Health Commission)

NMPA Releases "Good Clinical Practice for Drug Clinical Trials"

On the 26th, the National Medical Products Administration and the National Health Commission issued an announcement on the release of the Good Clinical Practice for Drug Clinical Trials (Announcement No. 57 of 2020). The regulations came into effect on July 1, 2020. (National Medical Products Administration, etc.)

Hubei Province Announces Results of Centralized Procurement for COVID-19 Testing Reagents: Six Companies Selected

On the 26th, the Hubei Provincial Pharmaceutical and Medical Device Centralized Procurement Service Platform released the “Public Notice of Proposed Winning Bidders for the Centralized Procurement of Novel Coronavirus-Related Testing Reagents in Hubei Province.” Four companies—Maccura Biotechnology, Da An Gene, Wuhan Mingde Bioengineering, and BGI Genomics—were selected as winning bidders for nucleic acid testing reagents for the novel coronavirus, while two companies—Zhuhai Livzon Diagnostics and Nanjing Vazyme Biotech—were selected for antibody testing reagents. (Hubei Provincial Pharmaceutical and Medical Device Centralized Procurement Service Platform)

Part 2 Industry Observation

Takeda Divests Multiple European Assets for $670 Million

Takeda Pharmaceutical announced on the 25th that it would continue to divest assets, selling the rights to a portfolio of approximately 110 non-core OTC and prescription products in Europe, as well as two production facilities in Denmark and Poland, to the Danish company Orifarm for up to $670 million. (PharmaCube)

Johnson & Johnson Partners with Emergent to Expand Production Capacity for Leading COVID-19 Vaccine Candidate

Johnson & Johnson Announces Strategic Partnership Between Janssen Pharmaceuticals and Emergent BioSolutions to Support Production of Its Lead COVID-19 Vaccine Candidate. Recently, Johnson & Johnson stated its plan to rapidly expand production capacity to ensure a global supply of over 1 billion safe and effective vaccine doses. (Bioon)

U.S. Oncology Firm ORIC Lists on Nasdaq, IPO Oversubscribed by 40%

On the 25th, ORIC Pharmaceuticals, an oncology company headquartered in California, USA, announced its official listing on NASDAQ. In early March this year, it had announced plans to raise $86 million through an IPO. Now, it has exceeded expectations by approximately 40%, successfully raising $120 million. (Chuangjianhui)

Part 3 Pharmaceutical News

First Domestic HPV Vaccine Available for Appointment and Vaccination Starting in May

Recently, the first batch of Xiamen Wantai Canghai Biotechnology Co., Ltd.'s bivalent human papillomavirus vaccine (brand name: Cecolin), totaling 93,643 doses, received the biological product lot release certificate from the National Medical Products Administration. Starting in May, most community hospitals in provinces and autonomous regions including Hubei, Xinjiang, Jilin, Yunnan, Jiangsu, and Shandong have opened appointments for vaccination, with the company aiming to achieve nationwide coverage by the end of the year. (Pharmaceutical Cube)

GSK Makes a Shining Debut in the PD-(L)1 Field!

GlaxoSmithKline recently announced the latest analysis data from the GARNET Phase I/II clinical study of the anti-PD-1 therapy dostarlimab (formerly TSR-042). The results showed that dostarlimab treatment provided clinically meaningful outcomes in patients with recurrent or advanced mismatch repair-deficient (dMMR) endometrial cancer who experienced disease progression during or after platinum-based chemotherapy. (Bioon)

Hengrui Launches Phase II Clinical Trial of PD-1 Inhibitor Combined with Famitinib for Advanced Solid Tumors

On the 24th, Hengrui Medicine registered the initiation of a Phase II study evaluating camrelizumab in combination with famitinib for the treatment of advanced solid tumors. The principal investigator of this trial is Professor Fan Jia from Zhongshan Hospital, Fudan University. The primary endpoint is the objective response rate, while secondary endpoints include duration of response, disease control rate, and progression-free survival assessed by imaging. (PharmaCube)

Zhifei Biological's Class 1 New Drug, Recombinant Mycobacterium tuberculosis Fusion Protein, Approved for Market Launch

Recombinant Mycobacterium tuberculosis Fusion Protein Developed by Anhui Zhifei Longcom Biopharmaceutical Co., Ltd. Approved for Market Launch by the National Medical Products AdministrationThe product will be used for: 1) screening for Mycobacterium tuberculosis infection; 2) in combination with purified protein derivative (PPD) of tuberculin, primarily to differentiate between Bacillus Calmette-Guérin (BCG) vaccination and Mycobacterium tuberculosis infection; 3) distinguishing among three populations—those who seroconverted to negative or were never infected with Mycobacterium tuberculosis after BCG vaccination, those who remained positive after BCG vaccination, and those infected with Mycobacterium tuberculosis—to facilitate the administration of different types of vaccines to each group; and 4) adjunctive clinical diagnosis of tuberculosis. (PharmaCube)

New Drug "Neratinib Tablets" for HER2+ Breast Cancer to Be Approved in China Soon

Recently, the marketing application for neratinib, a new drug introduced by Canfite Biopharma, has changed to "under review," with approval expected next month. Neratinib is the first globally approved drug for extended adjuvant therapy in patients with HER-2-positive early breast cancer. It is indicated for adult patients who have previously received trastuzumab-based therapy, aiming to reduce the risk of breast cancer recurrence. (CPhI Online)

Takeda’s ADC Drug “Brentuximab Vedotin” Is Set for Approval

On the 25th, the status of Takeda Pharmaceutical Company Limited's marketing application for brentuximab vedotin (JXSS1900015) at the NMPA was updated to "Under Review," indicating that the second antibody-drug conjugate in China is about to be approved. (Insight Database)

Novartis Submits IND for TIM-3 Monoclonal Antibody in China, Application Accepted

Latest CDE Public Notice: Novartis Submits Clinical Trial Application for MBG453 in China, Which Has Been Accepted. MBG453 is an investigational monoclonal antibody targeting the TIM-3 receptor developed by Novartis. This marks the first time a clinical trial application for this drug has been submitted in China. (Chuangjianhui)

Positive Phase 3 Clinical Results for Olaparib: Significantly Prolongs Overall Survival in Prostate Cancer Patients

AstraZeneca and Merck & Co. recently announced further positive results from the Phase III PROfound trial of the targeted anticancer drug Lynparza (olaparib) for the treatment of prostate cancer. The trial results demonstrated that, in patients with metastatic castration-resistant prostate cancer (mCRPC) harboring BRCA1/2 or ATM gene mutations (a subset of homologous recombination repair [HRR] gene mutations), Lynparza treatment yielded statistically significant and clinically meaningful improvements in the key secondary endpoint of overall survival, compared with enzalutamide or abiraterone. (Bioon)

Johnson & Johnson’s Anti-inflammatory Drug Simponi Aria Submitted for Approval in the US to Treat pJIA and jPsA

Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, recently announced that it has submitted two supplemental Biologics License Applications to the U.S. FDA, seeking approval for the anti-inflammatory drug Simponi Aria (golimumab) in combination with methotrexate for the treatment of polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis in patients aged 2 years and older. If approved, Simponi Aria would become the first intravenously administered tumor necrosis factor (TNF)-α inhibitor biologic available for the treatment of these juvenile arthritides. (Bioon)

Roche’s Satralizumab Significantly Reduces Relapse Risk in Phase 3 Clinical Trial for NMOSD

Roche Holding’s Japanese pharmaceutical subsidiary, Chugai Pharmaceutical, recently announced that the results of SAkuraStar, a global Phase III clinical study evaluating the antibody drug satralizumab as monotherapy for neuromyelitis optica spectrum disorders (NMOSD), have been published online in the international medical journal The Lancet Neurology. The results showed that, compared with placebo, satralizumab monotherapy significantly reduced the risk of relapse in patients with NMOSD and demonstrated favorable tolerability and safety. (Bioon)

U.S. FDA Approves RemeGen’s Novel ADC RC48 for Direct Entry into Phase II Clinical Trials

Recently, RC48 (disitamab vedotin; brand name: AidiXi), an antibody-drug conjugate (ADC) independently developed by RemeGen, has received FDA approval to directly initiate Phase II clinical trials in the United States for the indication of HER2-positive locally advanced or metastatic urothelial carcinoma. (PharmaCube)

Zai Lab’s Marketing Application for Omadacycline Tosylate Proposed for Priority Review

Zai Lab’s New Anti-Infective Drug, Omadacycline Tosylate (Omadacycline), Marketing Application Included in Priority Review Program under Category (I) for Three Innovative Drugs with Significant Therapeutic Advantages. (PharmCube)

Hengrui’s “Sodium Bicarbonate Ringer’s Injection” Price Cut by 66.78% in Shaanxi

On the 24th, the Shaanxi Provincial Drug and Medical Device Centralized Procurement Platform announced that the listed price cap for Hengrui Medicine’s Sodium Bicarbonate Ringer’s Injection (500 ml/bag) has been adjusted from RMB 295 to RMB 98, representing a 66.78% decrease. The adjusted price takes effect immediately. (PharmaCube)