Fosun Kite's Axicabtagene Ciloleucel Set to Become China's First Approved CAR-T Therapy; GSK Partners with Eligo in $224M Microbiome Deal

[January 12, 2021 / Pharmaceutical News Overview]BeiGene and Novartis Reach Strategic PD-1 Partnership; Roche’s Xofluza Approved by EU for Influenza Treatment; Fosun Kite’s Axicabtagene Ciloleucel Injection Nears Approval...Daily Fresh Pharmaceutical and Medical News, Speed Read Society Pays Attention with You!

Part 1 Policy Brief

Heilongjiang Reports One New Confirmed Case of COVID-19 and 36 New Asymptomatic Cases

From 0:00 to 24:00 on January 11, 2021, Heilongjiang Province reported one newly confirmed case of COVID-19 (the first asymptomatic infection in the current outbreak in Wangkui County was reclassified as a confirmed case). The patient has been transferred to a designated medical institution for isolation and treatment. Additionally, 36 new asymptomatic infections were reported, all among residents of Lijinghua Tun, Huiqi Village, Huiqi Town, Wangkui County. These individuals tested positive during nucleic acid screening of close contacts and secondary close contacts of the confirmed case. They have been diagnosed by experts as asymptomatic infections and have all been transferred to designated medical institutions for isolated medical observation. (CCTV News)

Beijing Reports One New Locally Acquired Confirmed Case: A 5-Year-Old Boy

From 00:00 to 24:00 on January 11, Beijing reported one new locally confirmed case, with no new suspected cases or asymptomatic infections; there were no new imported confirmed cases, suspected cases, or asymptomatic infections. The patient, a 5-year-old boy residing in Beishicao Village, Beishicao Town, Shunyi District, was placed under centralized medical observation as a close contact of a confirmed case on January 10. His nucleic acid test result was positive, and he was transferred to Ditan Hospital via a negative-pressure ambulance operated by the 120 emergency service. Based on a comprehensive assessment of his epidemiological history, clinical manifestations, laboratory tests, and imaging findings, he was diagnosed as a confirmed case on January 11, classified as moderate in severity. Epidemiological investigations have been conducted, and control measures have been implemented in accordance with requirements. (Global Times)

Hebei Province Has Reported a Cumulative Total of 326 Locally Acquired Confirmed Cases

From 00:00 to 10:00 on January 12, Hebei Province reported 21 new locally transmitted confirmed cases of COVID-19, including 16 in Shijiazhuang City and 5 in Xingtai City. Since January 2, the province has cumulatively identified 326 locally transmitted confirmed cases and 234 asymptomatic infections. Of these, Shijiazhuang City has reported a cumulative total of 304 locally transmitted confirmed cases and 229 asymptomatic infections; Xingtai City has reported 21 locally transmitted confirmed cases and 5 asymptomatic infections; and Gu'an County in Langfang City has reported one locally transmitted confirmed case. (CCTV News)

Part 2: Industry and Economic Observation

BeiGene and Novartis Reach Strategic Partnership on PD-1

On January 12, BeiGene announced that it had entered into a collaboration and license agreement with Novartis for the development, manufacturing, and commercialization of its self-developed anti-PD-1 antibody drug, tislelizumab, in multiple countries. The upfront payment amounted to $650 million, marking the highest upfront payment for any domestic drug licensing deal to date. (Sina Medical News)

GSK and Eligo Reach $224 Million Collaboration

On January 11, Eligo announced that it had entered into a research and selection agreement with GSK to develop Eligobiotics® for the treatment or prevention of acne vulgaris, as well as to create a CRISPR-based, strain-specific microbiome modulation therapy. It is understood that Eligobiotics® is a versatile, proprietary approach that enables the design, construction, and optimization of targeted microbiome species through an automated proprietary platform. This platform leverages Eligo’s unique expertise in synthetic biology, phage biology, CRISPR-Cas engineering, and bioinformatics. (Sina Pharmaceutical News)

Boehringer Ingelheim and Google Announce Partnership

Boehringer Ingelheim Announces Partnership with Google to Advance Quantum Computing in Drug DiscoveryRecently, the German pharmaceutical company Boehringer Ingelheim announced that it has signed a collaboration agreement with Google to jointly research and implement the application of quantum computing in drug development, particularly in areas such as molecular dynamics simulations. This new partnership is part of Boehringer Ingelheim’s comprehensive digital transformation strategy, aimed at better leveraging and accelerating its promising product pipeline. (Sina Medical News)

Hepalink Plans to Transfer Equity Stake in Kymab, Which Was Acquired by Sanofi

On January 11, Hepalink announced that its wholly-owned subsidiary, Hong Kong Hepalink, held an 8.66% equity stake in Kymab on a fully diluted basis. Sanofi FP BV, a wholly-owned subsidiary of Sanofi, entered into a share purchase agreement with all shareholders of Kymab, including Hong Kong Hepalink, to acquire 100% of the equity interests in Kymab. The total consideration for the acquisition comprises an initial payment of US$1.1 billion and subsequent milestone payments of up to US$350 million. (Hepalink Announcement)

Winner Medical’s Annual Earnings Forecast: Net Profit Exceeds RMB 3 Billion, a Fivefold Increase Year-on-Year

On January 12, Winner Medical disclosed its 2020 earnings forecast, projecting operating revenue for the reporting period to reach RMB 11.5 billion to RMB 13.5 billion, representing a year-on-year increase of 151% to 195%. Net profit was expected to range from RMB 3.65 billion to RMB 3.95 billion, marking a year-on-year growth of 568% to 623%. It is reported that the company’s independently developed raw material—pure cotton spunlace nonwoven fabric—is widely used in products such as surgical gowns, isolation gowns, protective suits, and face masks. During the epidemic, the company ramped up production of these anti-epidemic supplies, leading to significant sales growth across both online and offline channels, as well as in domestic and international markets, thereby further boosting its full-year performance. (Winner Medical Announcement)

Part 3 Pharmaceutical News and Medical Updates

Eli Lilly’s Alzheimer’s Antibody Therapy Meets Primary Endpoint in Phase 2 Clinical Trial

On January 12, Eli Lilly announced that donanemab, its monoclonal antibody targeting beta-amyloid, met the primary endpoint in a Phase 2 clinical trial, demonstrating a 32% slowing in the rate of decline on a composite measure assessing cognitive function and activities of daily living in patients with early Alzheimer’s disease. Donanemab binds specifically to the N3pG subtype of amyloid-beta; by targeting this subtype, it selectively binds to amyloid plaques in the brain, thereby facilitating their clearance. (WuXi AppTec)

Youhe Pharma Announces Breakthrough Results from Phase I Clinical Trial of CD40 in Combination with Junshi Biosciences’ PD-1 Inhibitor

On January 12, Youhe Pharma announced that its CD40 antibody in combination with Junshi Biosciences’ anti-PD-1 monoclonal antibody drug, toripalimab injection, demonstrated encouraging antitumor activity during the dose-escalation phase of a Phase I clinical trial in Australia. As of January 7, 2021, the subject had received four cycles (a total of 12 weeks) of the study treatment. An imaging assessment at Week 10 post-treatment indicated an overall response of partial response, with a 38.5% reduction in the sum of diameters of target lesions compared to baseline. No dose-limiting toxicities were observed, and no adverse events related to the study drugs occurred. (PR Newswire)

Ganlai Announces Positive Data from Phase I Clinical Trial of THR-β Agonist ASC41

On January 12, Ganlai Pharmaceuticals announced favorable data from the Phase I clinical trial of ASC41 oral tablets. ASC41 is a liver-targeted prodrug whose active metabolite is a selective agonist of the thyroid hormone beta receptor. In the multiple ascending-dose clinical study, after 14 days of once-daily oral administration of ASC41 tablets, subjects in the treatment group demonstrated clinically meaningful and statistically significant reductions in low-density lipoprotein cholesterol (LDL-C) and triglyceride levels compared with the placebo group. (PR Newswire)

Roche’s Xofluza Approved by EU for Influenza Treatment

On January 11, Roche announced that the European Commission had approved Xofluza® for the treatment of uncomplicated influenza in patients aged 12 years and older. Additionally, the European Commission has approved Xofluza for post-exposure prophylaxis of influenza in individuals aged 12 years and older. Post-exposure prophylaxis aims to prevent influenza infection following contact with an individual infected with the influenza virus. (Sina Pharmaceutical News)

CSPC’s IL-23p19 Antibody Clinical Trial Application Approved by the U.S. FDA

Recently, CSPC Pharmaceutical Group announced that its subsidiary, NovaRock Biotherapeutics, has received approval from the U.S. FDA for its Investigational New Drug (IND) application for NBL-012, a novel fully human antibody independently developed by the company. NBL-012 is an IL-23p19 antibody intended for the treatment of chronic inflammatory diseases, such as psoriasis, hidradenitis suppurativa, and inflammatory bowel disease, as well as other autoimmune disorders. (WuXi AppTec)

Targeting IL-6: BeiGene’s In-Licensed Siltuximab Proposed for Priority Review

On January 11, the Center for Drug Evaluation (CDE) announced that siltuximab for injection, licensed by BeiGene, is proposed to be included in the priority review program. It is intended for the treatment of adult patients with multicentric Castleman disease (MCD) who are human immunodeficiency virus (HIV)-negative and human herpesvirus-8 (HHV-8)-negative. Siltuximab is a monoclonal antibody that blocks the activity of interleukin-6 (IL-6), a pleiotropic cytokine whose elevated levels are detected in patients with multicentric Castleman disease. Since its initial approval in the United States in April 2014, the product has been approved in more than 40 countries and regions worldwide for the treatment of HIV-negative and HHV-8-negative multicentric Castleman disease. (Medical Observer)

CDE Proposes Breakthrough Therapy Designation: Amgen’s KRAS Inhibitor Sotorasib for the Treatment of NSCLC

On January 12, the CDE website indicated that Amgen’s KRAS G12C inhibitor sotorasib had its clinical trial application proposed for inclusion in the Breakthrough Therapy designation by the CDE. The intended indication in China is for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring KRAS p.G12C mutations who have previously received at least one systemic therapy. In patients with KRAS G12C-mutant NSCLC whose disease progressed after prior chemotherapy and/or immunotherapy, sotorasib achieved an objective response rate of 32.2% and a disease control rate of 88.1%, with a median progression-free survival of 6.3 months. The study also demonstrated that monotherapy with sotorasib led to tumor shrinkage in some patients. (PharmaCube Info)

China’s First CAR-T Therapy: Fosun Kite’s Axicabtagene Ciloleucel Injection Set for Approval

On January 12, the NMPA website showed that the marketing application for Fosun Kite’s CAR-T product, axicabtagene ciloleucel injection, had entered the administrative approval stage, with approval expected in the near future. This means that the first CAR-T therapy product in China is about to be approved for marketing. Axicabtagene ciloleucel injection is a CD19-targeted autologous CAR-T cell therapy product that Fosun Kite introduced from Kite Pharma in the United States under the YESCARTA technology and was authorized for localized production in China. On October 18, 2017, Yescarta was approved by the FDA for treating patients with relapsed or refractory large B-cell lymphoma, becoming the first CAR-T cell drug approved by the U.S. FDA for specific non-Hodgkin lymphoma. On August 27, 2018, it was approved for marketing in Europe for the treatment of relapsed or refractory DLBCL and PMBCL. (Insight Database)

Shanghai Allist Pharmaceuticals' Furmonertinib Mesylate Drug Clinical Trial Approved

On January 12, Shanghai Allist Pharmaceuticals announced that it had recently received the “Notice of Approval for Drug Clinical Trials” issued by the National Medical Products Administration (NMPA) for furmonertinib mesylate. The approval permits the conduct of a clinical trial evaluating furmonertinib mesylate as postoperative adjuvant therapy in patients with stage II–IIIA epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). Specifically, this is a randomized, double-blind, placebo-controlled, multicenter Phase III study comparing the efficacy and safety of furmonertinib versus placebo in patients with EGFR mutation-positive stage II–IIIA NSCLC who have undergone radical resection with or without adjuvant chemotherapy. (Announcement by Shanghai Allist Pharmaceuticals)

Innovent Biologics’ Third Indication Application for PD-1 Inhibitor Accepted

On January 12, Innovent Biologics announced that the National Medical Products Administration (NMPA) had accepted its new indication application for Tyvyt® (sintilimab), an innovative PD-1 inhibitor co-developed with Eli Lilly and Company, for the treatment of second-line squamous non-small cell lung cancer (NSCLC). This application marks the third supplemental New Drug Application (sNDA) for Tyvyt® in the field of NSCLC. The sNDA is based on a randomized, open-label, Phase 3 clinical trial evaluating the efficacy and safety of Tyvyt® as a second-line treatment for advanced or recurrent NSCLC after failure of first-line platinum-based chemotherapy. (Insight Database)

Fosun Pharma’s YP01001 Capsule Clinical Trial Application Accepted

On January 12, Fosun Pharma announced that its controlling subsidiary, Chongqing Yaoyou Pharmaceutical, had received a “Notice of Acceptance,” indicating that the National Medical Products Administration (NMPA) had accepted for review and registration the clinical trial application for YP01001 capsules, co-developed by the company, for the treatment of advanced solid tumors (such as liver cancer and gastric cancer). (Fosun Pharma Announcement)

Anke Biotech’s Application for New Indications of Recombinant Human Growth Hormone for Injection Accepted

On January 11, Anke Biotechnology announced that the National Medical Products Administration (NMPA) had accepted its marketing authorization application for the new indication of recombinant human growth hormone for injection in the treatment of idiopathic short stature (ISS). Recombinant human growth hormone has already been approved domestically and internationally for various pediatric indications related to short stature. The ISS indication added in this application has already been approved for marketing in the United States, but it has not yet been approved for marketing in China. (Anke Biotechnology Announcement)

Qilu’s Ceftriaxone Sodium for Injection Passes the Consistency Evaluation

On January 12, the official website of the National Medical Products Administration (NMPA) announced that Qilu Pharmaceutical’s Ceftriaxone Sodium for Injection had passed the consistency evaluation, making it the third company to achieve this milestone for this product, following Kelun Pharmaceutical and Shandong Runze. Ceftriaxone is a long-acting, broad-spectrum third-generation cephalosporin antibiotic. It exhibits enhanced activity against Gram-negative bacteria and greater stability against β-lactamases compared to first- and second-generation cephalosporins. Compared with other third-generation cephalosporins, it offers advantages such as a longer half-life, strong tissue penetration, and lower toxicity and side effects. Currently, it is widely used in clinical practice across departments including respiratory medicine, surgery, and obstetrics and gynecology. (PharmaCube Info)

Conba: Ambroxol Hydrochloride Injection Receives Generic Drug Consistency Evaluation

On January 12, Conba announced that it had received the "Drug Supplemental Application Approval" issued by the NMPA for Ambroxol Hydrochloride Injection, indicating that the drug has passed the generic drug consistency evaluation. Ambroxol Hydrochloride Injection is indicated for acute and chronic pulmonary diseases accompanied by abnormal sputum secretion and impaired expectoration, such as expectorant treatment for acute exacerbation of chronic bronchitis, asthmatic bronchitis, and bronchial asthma, as well as prophylactic treatment for postoperative pulmonary complications. This product has been included in the "National Reimbursement Drug List (2020 Edition)" as a Class B drug. (Conba Announcement)