Roche's CINtec®PLUS, the First Biomarker-Based HPV Triage Test, Receives FDA Approval; China's National Health Commission Announces Peak of Current COVID-19 Outbreak Has Passed

National Health Commission: The Peak of the Current Epidemic Outbreak in China Has Passed

On March 12, Mi Feng, spokesperson for the National Health Commission, stated that from 0:00 to 24:00 on March 11, Wuhan reported 8 new confirmed cases, dropping to single digits; all cities in Hubei Province except Wuhan had no new confirmed cases for seven consecutive days; other provinces outside Hubei reported 7 new confirmed cases, including 6 imported cases. The above information indicates that, overall, the peak of the current epidemic outbreak in China has passed, with a continuous decline in new cases and the epidemic generally remaining at a low level.

Preliminary Clinical Results of Favipiravir in the Treatment of COVID-19 Released: Viral Clearance Time Shorter Than That of Lopinavir/Ritonavir

On March 11, 2020, preliminary results were released from a collaborative clinical study titled “A Clinical Study on the Safety and Efficacy of Favipiravir in Treating Patients with Novel Coronavirus Pneumonia (COVID-19)” (Registration No.: ChiCTR2000029600), conducted by the National Engineering Research Center for Emergency Prevention and Control Drugs and Shenzhen Third People’s Hospital. The findings suggest that favipiravir may alleviate the progression of COVID-19 by accelerating viral clearance. The median time to viral clearance in the 35 patients treated with favipiravir was significantly shorter, at 4 days (interquartile range: 2.5–9 days), compared with 11 days (interquartile range: 8–13 days) in the control group treated with lopinavir/ritonavir tablets, indicating a statistically significant difference between the two groups.

Roche's Next-Generation HPV Testing Product: CINtec^®PLUS Receives FDA Approval for Market Launch

On March 11, Roche announced that the U.S. FDA had approved its next-generation cytology test, CINtec^®PLUS, the first biomarker-based classification assay, is used via cobas^®4800 Primary cervical cancer screening for women who test positive for human papillomavirus (HPV). Roche states that the CINtec PLUS Cytology Test can identify women with HPV infections most likely to be associated with cervical cancer. It enables clinicians to more confidently determine which women should be immediately referred for colposcopy or other diagnostic procedures, thereby helping to prevent the progression to more severe cervical disease.

Opdivo Approved in China for Its Third Indication: Treatment of Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma

On March 11, the new indication applications for Opdivo (JXSS1900037, JXSS1900038) were approved by the NMPA for the treatment of advanced or recurrent gastric adenocarcinoma and gastroesophageal junction adenocarcinoma in patients who have received two or more prior systemic therapy regimens. This marks the third indication for Opdivo approved in China.

Stelara under Janssen (Xi'an)^®New Indication for Adult Crohn's Disease Approved

On March 12, Janssen China announced its Stelara^®（STELARA^®) two formulations, ustekinumab injection for subcutaneous injection and ustekinumab injection for intravenous infusion (intravenous infusion), have been approved by the National Medical Products Administration of China. They are indicated for adult patients with moderately to severely active Crohn's disease (CD) who have had an inadequate response, lost response, or intolerance to conventional therapy or tumor necrosis factor alpha (TNFα) antagonists. This accelerated approval was facilitated by the inclusion of Stelara on May 29, 2019, by the National Medical Products Administration and the National Health Commission.^®Included in the second batch of overseas new drugs urgently needed for clinical use. Stelara^®(Ustekinumab) is the first fully human "dual-target" interleukin-12 (IL-12) and interleukin-23 (IL-23) inhibitor approved in China.

Bristol Myers Squibb’s Dual Immunotherapy Combination Approved by FDA for the Treatment of Patients with Hepatocellular Carcinoma

On March 11, Bristol Myers Squibb (BMS) announced that the U.S. FDA had approved the PD-1 inhibitor Opdivo (nivolumab) in combination with the CTLA-4 inhibitor Yervoy (ipilimumab) for the treatment of patients with hepatocellular carcinoma (HCC) who have previously been treated with sorafenib. The press release noted that Opdivo plus Yervoy is the first and only dual immunotherapy approved by the FDA for this patient population. This combination therapy features a potentially synergistic mechanism of action.

Mylan and Biocon Announce FDA Acceptance of Biologics License Application for MYL-1402 (Bevacizumab Biosimilar)

Recently, Mylan and its partner, the Indian biopharmaceutical company Biocon, jointly announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan’s Biologics License Application (BLA) for MYL-1402O, a biosimilar of bevacizumab. The application will be reviewed under the 351(k) pathway, with a Biosimilar User Fee Act (BsUFA) goal date of December 27, 2020. MYL-1402O is a biosimilar to Roche’s flagship biologic Avastin (generic name: bevacizumab).

Jianfeng Pharmaceutical’s Paroxetine Hydrochloride Tablets Pass Consistency Evaluation

Recently, Zhejiang Jianfeng Group Co., Ltd. announced that its controlling subsidiary, Zhejiang Jianfeng Pharmaceutical Co., Ltd., had received the "Drug Supplemental Application Approval" (Approval No.: 2020B02472) issued by the National Medical Products Administration for Paroxetine Hydrochloride Tablets. The paroxetine hydrochloride tablets produced by Jianfeng Pharmaceutical have passed the consistency evaluation of quality and efficacy for generic drugs. This product is indicated for the treatment of depression, obsessive-compulsive disorder, panic disorder with or without agoraphobia, and social phobia/social anxiety disorder.

Biopharmaceutical Company Oncernal Announces Data from Trial of Cirmtuzumab in Combination with Imbruvica for the Treatment of Lymphoma

Recently, Oncernal Therapeutics, a clinical-stage biopharmaceutical company, announced updated data from the Phase I/II CIRLL study evaluating cirmtuzumab in combination with Imbruvica (ibrutinib) for the treatment of relapsed or refractory mantle cell lymphoma (R/R MCL). The results showed that, with a median follow-up of 6.4 months, among 12 evaluable patients, the complete response rate was 50% (6/12), the partial response rate was 33% (4/12), and the stable disease rate was 17% (2/12), according to the Cheson criteria for malignant lymphoma. The best overall objective response rate was 83%, and the clinical benefit rate was 100%.

Fosun Pharma Initiates Phase III Clinical Study of HLX10 in Combination with Chemotherapy (Albumin-bound Paclitaxel) for Advanced Cervical Cancer

On March 11, Fosun Pharma announced that its controlling subsidiary, Shanghai Henlius Biotech, Inc., has initiated a Phase II clinical trial in China for the combination of HLX10 (a recombinant humanized anti-PD-1 monoclonal antibody injection) and chemotherapy (albumin-bound paclitaxel) in the treatment of advanced cervical cancer that has progressed after first-line chemotherapy. HLX10 is an innovative therapeutic biologic independently developed by the Group, intended for the treatment of solid tumors, with ongoing exploration of its potential in the treatment of chronic hepatitis B.

Fosun Pharma’s New Drug for Hyperphosphatemia to Initiate Phase III Clinical Trials

Recently, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced that its controlling subsidiary, Shanghai Fosun Pharmaceutical Industry Development Co., Ltd., had received a notice from the National Medical Products Administration approving the conduct of clinical trials for Tenapanor tablets (specifications: 10 mg/20 mg/30 mg) in the treatment of hyperphosphatemia in patients with end-stage renal disease on hemodialysis (ESRD-HD). Fosun Pharmaceutical Industry plans to initiate Phase III clinical trials for this indication within mainland China (excluding Hong Kong, Macao, and Taiwan regions; hereinafter referred to as “China”) once the necessary conditions are met in the near future.

Hybribio's 2019-nCoV Nucleic Acid Detection Kit Receives EU Certification

Recently, Hybribio’s Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (Fluorescent PCR Method), i.e., the COVID-19 Real-time PCR Kit, successfully obtained EU CE certification with the assistance of Emergo by UL, a leading international compliance consulting firm for medical devices and IVD products.

InnoCare Pharma Plans to Offer 250 Million Shares, Expected to List on March 23

On March 11, InnoCare Pharma, a clinical-stage biopharmaceutical company, announced that it would conduct its initial public offering from March 11 to March 16, 2020. The company plans to offer a total of 250 million shares, including 25.034 million shares for the Hong Kong public offering and 225 million shares for the international offering. The indicative offer price ranges from HK$8.18 to HK$8.95 per share, with a board lot size of 1,000 shares. Trading is expected to commence on March 23. Assuming the over-allotment option is not exercised and the offer price is set at HK$8.56 per share, the net proceeds are estimated to be approximately HK$1.999 billion. It is expected that around 50.0% of these proceeds will be used to fund ongoing and planned clinical trials of orelabrutinib in both China and the United States, prepare regulatory filing documents, and support potential commercial launch activities (including sales and marketing).

Regeneron and Sanofi Plan to Test Rheumatoid Arthritis Drug Kevzara for Efficacy in Treating COVID-19

Recently, a Regeneron spokesperson stated that the company is preparing to test the therapeutic efficacy of Kevzara in patients with COVID-19 in collaboration with Sanofi. Kevzara, an IL-6 inhibitor co-developed by Regeneron and Sanofi, was approved by the U.S. FDA in 2017 for the treatment of rheumatoid arthritis. Regarding the COVID-19 trials of Kevzara, Regeneron will lead the studies in the United States, while Sanofi will advance the research internationally. In addition to Kevzara, Regeneron is also investigating the efficacy of a combination regimen of REGN3048 and REGN3051 for COVID-19. The antibodies under investigation in this study are all capable of binding to the S protein of the MERS coronavirus.

Aurora Biopharma and Clearside Reach Licensing Agreement for XIPERE™ in Greater China and South Korea

On March 11, 2020, Jimu Fengrui (Shanghai) Biotechnology Co., Ltd. announced that it had secured exclusive licensing rights to develop and commercialize Clearside Biomedical’s core product, XIPERE™ (triamcinolone acetonide suprachoroidal injection suspension), in the Greater China region (including mainland China, Hong Kong, Macao, and Taiwan) and South Korea. XIPERE™ is a patented triamcinolone acetonide suspension formulation designed for suprachoroidal administration, delivered via Clearside’s proprietary SCS Microinjector™, and is currently under investigation as a targeted therapy for uveitic macular edema. Under the terms of the agreement, Clearside is eligible to receive up to a total of USD 35.5 million in development and sales milestone payments.