Rao Yi Re-Files Misconduct Allegations Against Academician Pei Gang; Genentech’s Esbriet Granted FDA Priority Review

[January 22, 2021 / Pharmaceutical News Overview]Rao Yi Reports Pei Gang for Academic Misconduct; XinKaiNuo Medical Completes Nearly RMB 100 Million in Series B Financing; Genentech’s Esbriet Granted Priority Review Status...Daily Fresh Pharmaceutical and Medical News, Sudu She Pays Attention with You!

Part 1 Policy Brief

Beijing Reports 3 New Local Confirmed Cases, All Residing in Ronghui Community, Tiangongyuan Subdistrict, Daxing District

From 00:00 to 24:00 on January 21, three new locally confirmed cases and one asymptomatic infection were reported, with no new suspected cases; two new imported asymptomatic infections were reported, with no new confirmed or suspected cases. All three confirmed cases reside in the Ronghui Community of Tiangongyuan Subdistrict. Epidemiological investigations have been conducted for the aforementioned confirmed cases, and control measures have been implemented as required. (Beijing Daily)

Heilongjiang Reports 47 New Confirmed Cases and 88 New Asymptomatic Cases

From 0:00 to 17:00 on January 21, 2021, Heilongjiang Province reported 47 newly confirmed cases of COVID-19 (35 in Wangkui County, Suihua City, including 7 cases converted from asymptomatic infections; 1 case converted from an asymptomatic infection in Hailun City, Suihua City; 1 case converted from an asymptomatic infection in Zhaozhou County, Daqing City; 7 cases in Limin Development Zone, Harbin City; and 3 cases in Hulan District, Harbin City); and 88 newly identified asymptomatic infections (42 in Wangkui County, Suihua City; 8 in Hailun City, Suihua City; 5 in Anda City, Suihua City; 22 in Limin Development Zone, Harbin City; 9 in Hulan District, Harbin City; and 2 in Ang'angxi District, Qiqihar City). (CCTV News)

Jilin Province Reports 19 New Local Confirmed Cases

From 0:00 to 24:00 on January 21, the province reported 19 new locally transmitted confirmed cases (10 in Changchun City and 9 in Tonghua City), including one case (in Tonghua City) that was converted from a previously reported asymptomatic infection to a confirmed case. As of now, the province has cumulatively reported 181 confirmed cases associated with this imported outbreak (132 in Tonghua City, 47 in Changchun City, and 2 in Songyuan City), including 4 critical cases, 11 severe cases, 141 moderate cases, and 25 mild cases. As of 24:00 on January 21, the province had cumulatively reported 319 local confirmed cases, with 136 patients cured and discharged, 181 patients undergoing isolated treatment in hospitals, and 2 deaths. (CCTV News)

Shanghai Municipal Health Commission: 112 Close Contacts Traced, All Initial Nucleic Acid Test Results Negative

On January 22, the Shanghai Municipal Health Commission stated that as of 12:00 on January 22, 112 close contacts in Shanghai had been traced for the six cases confirmed the previous day, with all initial nucleic acid test results returning negative. Centralized quarantine and medical observation measures have been implemented, with re-sampling to be conducted after 24 hours. A total of 234 secondary close contacts (contacts of close contacts) have been identified and sampled; 205 tested negative, while the remaining samples are still under testing. Centralized quarantine and medical observation measures have also been implemented for this group. Additionally, 15,918 relevant individuals have been screened, with 15,907 testing negative and the rest currently undergoing testing. Corresponding control measures have been put in place. (Shanghai Municipal Health Commission)

NetEase Beijing Employee Tests Positive for Nucleic Acid, Not Yet Confirmed

On January 22, it was reported that NetEase issued an internal company-wide email at noon today, stating that an employee at its Beijing campus tested positive for the nucleic acid test on the night of January 21, but tested negative in a serum test in the early hours of January 22, and has not yet been confirmed as a case. In the internal email, NetEase stated that all personnel at the Beijing campus would undergo nucleic acid testing and work from home. (Phoenix Technology)

On the Night Official Authorities Announced That Pei Gang, Cao Xuetao, and Others Were Not Involved in Paper Fabrication, Rao Yi Reported Academic Misconduct by Academician Pei Gang

On January 21, the official website of China’s Ministry of Science and Technology released an announcement detailing the findings of an investigation into allegations of research misconduct involving papers authored by Academician Cao Xuetao of Nankai University, Academician Pei Gang of the Chinese Academy of Sciences (CAS), Researcher Geng Meiyu of the Shanghai Institute of Materia Medica (CAS), Professor Rao Yi of Capital Medical University, and Professor Li Hongliang of Wuhan University. The announcement stated that no evidence of fabricated data was found in the work of these individuals; however, Academician Cao Xuetao, Professor Li Hongliang, and Researcher Geng Meiyu received varying degrees of disciplinary action due to inadvertent misuse of images. On the evening following the release of this announcement, Professor Rao Yi once again published on his WeChat public account “Rao Yi Science” a formal email reporting Academician Pei Gang, stating, “This is the first time I have reported the alleged misconduct in this paper to the Chinese Academy of Sciences, and also the first time I have formally reported such allegations to any institution.” (BioExplorer)

Part 2: Industry and Economic Observation

Xinkainuo Medical Completes Nearly RMB 100 Million in Series B Financing

Recently, XinKaiNuo Medical officially announced the completion of its nearly RMB 100 million Series B financing round, led by Zeyue Capital, with participation from Chuangban Investment and existing shareholder Anlong Fund. The funds raised will be primarily used for new product development and clinical trials, market promotion, and corporate operations, thereby accelerating the regulatory approval and localization of more than 15 products in XinKaiNuo Medical’s portfolio and strengthening the company’s presence in the neurointerventional and peripheral intervention markets. (YiGu)

Edge Medical Completes Nearly RMB 600 Million Series B Financing

In January 2021, Edge Medical announced the completion of its Series B financing round, raising nearly RMB 600 million. The round was co-led by LYFE Capital and Kangji Medical, with existing shareholders Sanzheng Health Investment and Guoce Investment also serving as co-lead investors. Vertex Ventures, Boyuan Capital, Yahui Investment, and existing shareholder Poly Capital participated as follow-on investors. This financing will further propel Edge Medical’s surgical robot business into a new phase. (Arterial Network)

Lepu Medical: The company's self-developed novel coronavirus antibody and antigen test kits are primarily targeted at overseas markets.

On January 22, Lepu Medical stated on its investor interaction platform that the novel coronavirus antibody and antigen test kits independently developed by the company are primarily targeted at overseas markets, aiming to meet the global demand for rapid testing and epidemic prevention and control in relevant countries and regions. (Cailianshe)

Part 3 Pharmaceutical News and Medical Updates

Efficacy of Eli Lilly's Neutralizing Antibodies for COVID-19 Prevention in the Elderly Can Reach 80%

On January 22, Eli Lilly announced that bamlanivimab, a SARS-CoV-2 neutralizing antibody co-developed with AbCellera, significantly reduced the risk of developing symptomatic COVID-19 among residents and staff in long-term care facilities in the Phase 3 BLAZE-2 clinical trial. Notably, for elderly individuals residing in these facilities, the antibody reduced their risk of infection by 80%. (WuXi AppTec)

FDA Approves First Long-Acting Injectable HIV Therapy, Requiring Only Monthly Dosing

Today, the U.S. FDA announced the approval of Cabenuva, developed by ViiV Healthcare, as a complete regimen for the treatment of adult patients with HIV-1 infection who have achieved virologic suppression following antiretroviral therapy. These patients have no history of treatment failure and no known or suspected resistance to cabotegravir or rilpivirine. This marks the first FDA-approved complete injectable regimen for adult patients with HIV infection, requiring only once-monthly administration. (WuXi AppTec)

Genentech’s Esbriet Granted FDA Priority Review

On the 22nd, Genentech, a member of the Roche Group, announced that the U.S. FDA had accepted its supplemental new drug application for Esbriet for the treatment of unclassifiable interstitial lung disease. The FDA also granted priority review to this application and will make a decision by May 2021. (WuXi AppTec)

Huahai Pharmaceutical: Approval Granted for Clinical Trial of HB0025 Injection

Huahai Pharmaceutical announced on January 22 that its subsidiaries, Huaota and Huabo Biopharm, recently received the "Notice of Approval for Drug Clinical Trials" for HB0025 Injection, approved by the NMPA. The indications are advanced solid tumors and hematologic malignancies. (Huahai Pharmaceutical Announcement)

Olaparib’s New Indication Application for Market Approval Proposed for Priority Review: Treatment of Prostate Cancer

On January 21, the CDE website indicated that AstraZeneca’s new indication application for olaparib tablets was proposed to be included in the priority review program. The application is for olaparib monotherapy in adult patients with metastatic castration-resistant prostate cancer (mCRPC) harboring BRCA1/2 mutations (germline and/or somatic) who have experienced disease progression following prior treatment with novel hormonal agents. (PharmCube)

GSK’s Dual-Drug HIV Therapy Proposed for Priority Review

Latest Announcement on the CDE Website: The New Drug Application for GlaxoSmithKline’s Dual-Drug HIV Therapy—Dolutegravir and Rilpivirine Tablets—is Proposed for Priority Review. The Proposed Indication Is: For the Treatment of Adult Patients with Human Immunodeficiency Virus Type 1 (HIV-1) Infection Who Have Achieved Virologic Suppression for at Least Six Months on a Stable Antiretroviral Regimen, Have No History of Virologic Failure, and Have No Known or Suspected Resistance to Non-Nucleoside Reverse Transcriptase Inhibitors or Integrase Inhibitors. (WuXi AppTec)

RuiShi Biologics’ JAK1 Inhibitor Proposed for Inclusion in Breakthrough Therapy Designation

Latest Announcement on the CDE Website: Hengrui Medicine’s Subsidiary Ruishe Bio’s Novel Class 1 Drug SHR0302 Proposed for Inclusion in Breakthrough Therapy Designation, Intended for the Treatment of Moderate-to-Severe Atopic Dermatitis in Adolescents Aged 12 Years and Older and Adults. Public information indicates that SHR0302 is a first-in-class, independently developed, highly selective JAK1 inhibitor under development by Ruishe Bio, which previously met both primary and secondary endpoints in Phase II clinical trials for atopic dermatitis. (Yiyao Guanlan)

Livzon’s Triptorelin Pamoate Microspheres for Injection Clinical Trial Application Accepted

On January 22, data from the official website of the Center for Drug Evaluation (CDE) showed that Livzon’s Class 2.2 new drug, Triptorelin Pamoate for Injection (Microspheres), had its clinical trial application accepted for review. Previously, Livzon had submitted applications for four microsphere products, among which Leuprorelin Acetate for Injection (Microspheres) has already been approved for marketing. Livzon stated that future R&D efforts on its microsphere platform will focus on three major therapeutic areas—oncology, antipsychotics, and endocrine regulation—adopting a strategy combining imitation and innovation. (Menet)

Chengdu Baiyu Pharmaceutical’s Tolvaptan Tablets Class 4 Generic Marketing Application Accepted

According to data from the CDE website, Chengdu Baiyu Pharmaceutical’s Class 4 generic marketing application for tolvaptan tablets was accepted today. Tolvaptan currently has import approval in the Chinese market, but no domestically produced generic versions have yet been approved. Tolvaptan is a selective, competitive vasopressin V2 receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia, including in patients with heart failure and syndrome of inappropriate antidiuretic hormone secretion (SIADH). (Menet)