Bristol Myers Squibb Announces CheckMate -274 Trial of Nivolumab Meets Primary Endpoints in High-Risk Muscle-Invasive Urothelial Carcinoma

[February 10, 2021 / Pharmaceutical News Overview]Lilly Announces FDA Emergency Use Authorization for COVID-19 Neutralizing Antibody Combination Therapy; Nivolumab CheckMate -274 Study Meets Primary Endpoint...Daily Fresh Pharmaceutical and Medical News, Speed Read Society Pays Attention with You!

Part 1 Policy Brief

Tracing the Origins of SARS-CoV-2: WHO Expert Group Releases Key Findings and Recommendations for Next Steps in Research

On February 9 local time, the China-WHO Joint Expert Team on Tracing the Origins of the Novel Coronavirus held a press conference in Wuhan, China. Since their arrival in Wuhan, the international expert team from the World Health Organization has conducted research on the origins of SARS-CoV-2 from the perspectives of epidemiology, animals and the environment, as well as molecular epidemiology and biology. At the press conference, representatives of the expert team not only reported the main findings of the study on tracing the origins of the novel coronavirus but also proposed recommendations for the direction of future research. (WuXi AppTec)

NMPA: Abolish 8 Certification Items and Replace with Internal Review

On February 9, 2021, the National Medical Products Administration (NMPA) issued an announcement on the cancellation of eight certification requirements (Fourth Batch). The announcement clarified that applicants are no longer required to submit eight types of documentation, including New Drug Certificates, Business Licenses, Production Licenses, certificates for Marketing Authorization Holders of drugs, and Batch Release Certificates for biological products; instead, these will be subject to internal verification or online validation. (National Medical Products Administration)

NMPA: 56 Novel Coronavirus Test Reagents Approved

On February 10, according to the National Medical Products Administration (NMPA) website, as of February 10, 2021, the NMPA had approved 56 novel coronavirus testing reagents through its review and approval process. These included 26 nucleic acid testing reagents, 27 antibody testing reagents, and 3 antigen testing reagents. The daily production capacity for nucleic acid testing reagents was 6.656 million tests, for antibody testing reagents 16.46 million tests, and for antigen testing reagents 1.903 million tests, resulting in a cumulative daily production capacity of 25.019 million tests. (National Medical Products Administration)

Four Departments Issue Notice to Conclude the Pilot Program for Traditional Chinese Medicine Formula Granules

On February 10, the National Medical Products Administration (NMPA), the National Administration of Traditional Chinese Medicine (NATCM), the National Health Commission (NHC), and the National Healthcare Security Administration (NHSA) jointly issued the "Announcement on Concluding the Pilot Program for Traditional Chinese Medicine Formula Granules," which aims to end the pilot program and clarify the regulatory framework to be implemented thereafter. According to the Announcement, traditional Chinese medicine (TCM) formula granules will be subject to a filing-based management system; their quality supervision will be incorporated into the regulatory scope for TCM decoction pieces, and policies governing their clinical use will be formulated separately by the relevant authorities. The Announcement sets forth capability requirements for manufacturers of TCM formula granules and clarifies provisions regarding standard implementation, inter-provincial distribution and use, and medical insurance reimbursement, thereby laying the groundwork for the subsequent establishment of a comprehensive regulatory system for TCM formula granules. (National Medical Products Administration)

Part 2: Industry and Economic Observation

NewFos Biotech Completes 400 Million Yuan Series B Financing

On February 9, Aurora Venture Capital announced via its official WeChat account that NeufuSight Biologics, a company focused on developing gene therapies for ophthalmic diseases, has completed a RMB 400 million Series B financing round. The round was co-led by Guofang Capital and Huaxin Investment, with participation from prominent investment firms including Yuanfeng Capital, Yuanhe Holdings, and Huiyuan Capital. Existing shareholders Sequoia Capital China and Aurora Venture Capital continued to increase their investments. (WuXi AppTec)

Jifan Biologics Completes Nearly RMB 150 Million in Series A Financing

Arterial Network has learned that Jifan Biology recently announced the completion of its RMB 150 million Series A financing round, jointly led by Sequoia Capital China and Legend Capital, with Chana Capital serving as the exclusive financial advisor. The funds raised will primarily be used to advance the research and development of the company’s sample pre-processing products, channel construction, and overseas market expansion. (Arterial Network)

Econo Completes Nearly 100 Million Yuan in Series A2 Financing

Arterial Network has learned that Chineo has completed a new round of nearly RMB 100 million in Series A2 financing, invested by Sinovation Ventures. Previously, Chineo had received investments from Chende Capital, ZhenFund, and Nanchuang Capital. The funds raised will mainly be used for the clinical trials of instruments and reagent products, the application for NMPA registration certificates, and the transfer of production. (Arterial Network)

Chineo Completes Pre-B Round Financing of Hundreds of Millions of Yuan

Arterial Network learned that Beijing Chineo Medical announced the completion of a hundred-million-yuan Pre-B round of financing, led by Foison Capital. The funds will be used to support Chineo Medical’s “super-enhanced TIL” cell therapy product in completing its Investigational New Drug (IND) application. It is reported that Chineo Medical had previously secured Series A+ financing from investors including the CCB Medical Growth Fund. (Arterial Network)

Zhiyin Dongfang Completes Over RMB 100 Million in Series B Financing

VBData learned that Beijing Zhiyin Dongfang has announced the completion of its Series B financing, exceeding RMB 100 million. This round was led by Bencao Capital, with participation from Yijing Capital, Feitu Ventures, and other institutional investors. The funding will further support Zhiyin Dongfang’s rapid advancement in the field of precision diagnosis for genetic diseases using big data. It is reported that Zhiyin Dongfang previously completed a Series A+ financing round worth hundreds of millions of RMB, led by prominent institutions including Fortune Capital, Fosun, and Yahui. (VBData)

Yinjia Bio Completes Tens of Millions of Yuan in Angel Financing

Arterial Network learned that on February 10, 2021, Yinjia Biotech announced the completion of its angel round financing, amounting to tens of millions of RMB. The investment was led by CDH Investments, with Furong Capital participating as a co-investor. Established in 2020 in the Lingang New Area of the Shanghai Pilot Free Trade Zone, Yinjia Biotech has simultaneously set up R&D and production bases in Shanghai, Beijing, and Suzhou. (Arterial Network)

Hangzhou Changxi Pharmaceutical Introduces Inhaled Imatinib

On February 9, Hangzhou Changxi Pharmaceutical and Aerami Therapeutics announced that they had signed an exclusive license and product development agreement. Under the agreement, Changxi will obtain from Aerami the exclusive rights to develop and commercialize AER-901, its investigational drug candidate for pulmonary arterial hypertension (PAH), in the Greater China region (mainland China, Hong Kong, Macau, and Taiwan). According to the terms, Changxi will be fully responsible for the development and commercialization of AER-901 for the treatment of PAH in the Greater China region, including conducting clinical trials and filing for marketing approval in China. (PharmCube)

WuXi AppTec’s Investee Company Adagene Listed on Nasdaq

On February 10, WuXi AppTec announced that its associate company, Adagene, was listed on the NASDAQ Stock Market in the United States on February 9, 2021 (U.S. time), with the stock ticker symbol: ADAG. Following the completion of Adagene’s global offering, WuXi AppTec holds 5,356,946 shares of Adagene through its wholly-owned subsidiary, WuXi Pharma Tech Health Care Fund I L.P., representing approximately 10.16% of Adagene’s total issued share capital after the issuance. (WuXi AppTec Announcement)

Part 3 Pharmaceutical News and Medical Updates

Early Results of UK COVID-19 Vaccination Study: Pfizer’s First Dose Shows 64% Efficacy

On February 10, early results from the UK government’s vaccination program showed that the risk of infection in young people dropped by 65% after the first dose of the Pfizer-BioNTech vaccine, while the risk in those aged 80 and older decreased by 64%. The specific data from the study are expected to be officially released within a few days. (Cailianshe)

Nivolumab CheckMate -274 Study Meets Primary Endpoint

On February 9, Bristol Myers Squibb China announced the results of the Phase 3 clinical trial CheckMate -274: Opdivo (nivolumab) as adjuvant therapy for patients with high-risk muscle-invasive urothelial carcinoma after surgery met the primary endpoint in both the overall randomized population and in patients with PD-L1 expression ≥1%, significantly improving disease-free survival. (WuXi AppTec)

Regeneron/Sanofi PD-1 Inhibitor Secures Second Indication

Regeneron and Sanofi Jointly Announce FDA Approval of Libtayo for Advanced Basal Cell CarcinomaToday, Regeneron and Sanofi jointly announced that the U.S. FDA has approved an expanded indication for the PD-1 inhibitor Libtayo to treat patients with advanced basal cell carcinoma who have previously been treated with a hedgehog pathway inhibitor (HHI) or are not suitable candidates for HHI therapy. The press release noted that Libtayo is the first immunotherapy approved for this type of cancer. (WuXi AppTec)

Lilly Announces FDA Emergency Use Authorization for COVID-19 Neutralizing Antibody Combination Therapy

On February 10, Eli Lilly announced that the U.S. FDA had granted Emergency Use Authorization (EUA) for the neutralizing antibody combination therapy of bamlanivimab 700 mg and etesevimab 1400 mg for the treatment of mild to moderate COVID-19 in patients aged 12 years and older who are at high risk of progressing to severe disease or hospitalization. Following confirmation of a positive COVID-19 test, patients can receive the bamlanivimab and etesevimab combination therapy via a single intravenous infusion within 10 days of symptom onset. (WuXi AppTec)

Merck’s Expanded Label Application for Keytruda in Triple-Negative Breast Cancer Fails to Gain FDA Support

This Tuesday, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously (10-0) against the accelerated approval of Merck’s immuno-oncology blockbuster Keytruda, passing a recommendation that “the U.S. FDA should defer its decision on Merck’s application to expand the label of Keytruda for triple-negative breast cancer until the company provides additional data from the Phase III KEYNOTE-522 clinical trial.” (Sina Medical News)

Fosun Pharma’s NS002 Tablets Receive FDA Approval for Clinical Trials

Today, Fosun Pharma announced that its controlled subsidiary, Novelstar, has received a letter from the U.S. FDA approving the conduct of clinical trials for NS002 tablets in the treatment of inflammatory joint diseases. Novelstar plans to initiate bioavailability (BA) clinical trials for this new drug for the aforementioned indication in the United States once conditions permit in the near future. (Fosun Pharma Announcement)

Chineo’s CAR-NK Cell Therapy Files for Clinical Trial Approval in China

On February 9, the website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) announced that the clinical trial application for Guojian Chengnuo Biotechnology’s Class 1 novel drug, “Mesothelin-Targeted Chimeric Antigen Receptor NK Cell Injection,” had been accepted. Reportedly, this clinical trial targets advanced epithelial ovarian cancer. Notably, CAR-NK therapy was listed by Nature Medicine as one of the ten notable advances in biomedicine in 2020. (WuXi AppTec)

Ettitude’s New Cardiovascular Drug Application for Market Approval Accepted in Mainland China and Hong Kong

On February 9, Eddingpharm announced that the marketing authorization applications for Vascepa in mainland China and Hong Kong had been formally accepted by the National Medical Products Administration (NMPA) and the Drug Office of the Department of Health of Hong Kong, China, respectively. The marketing authorization application for Vascepa in the Hong Kong Special Administrative Region will be evaluated by the Drug Office of the Department of Health of Hong Kong, China, with reference to its current approval status in the United States and Canada. The review process is expected to be completed by the end of 2021. Vascepa is primarily indicated for the treatment of high-risk patient populations with persistent cardiovascular risk despite statin therapy. (Immediate Pharma News)

CanSino Biologics: Ad5-nCoV Has Received Emergency Use Authorization from the Mexican Federal Commission for the Protection against Sanitary Risks

On the 10th, CanSino Biologics announced on the Hong Kong Stock Exchange that, based on the interim results of the Phase III clinical trial of its recombinant novel coronavirus vaccine (adenovirus type 5 vector), Ad5-nCoV had received emergency use authorization from Mexico’s Federal Commission for the Protection against Sanitary Risks (COFEPRIS) on February 9, 2021 (local time), for use in adults aged 18 and older. (CanSino Biologics Announcement)