SUN Nan Resigns from Rightongene; InnoCare's Orelabrutinib Approved for Clinical Trial in NMOSD

[March 2, 2022/Medical News Overview] NextRNA announces over 56 million USD financing to boost the development of small molecule therapies; Overland Pharma appoints Xun Liu as Chief Technology Officer; Boehringer Ingelheim/Eli Lilly’s empagliflozin tablets new indication proposed for priority review… For the latest pharmaceutical news and medical updates, follow Speed Reading Society!

Policy Brief

NMPA Seeks Public Opinions on Matters Related to the Filing of Class I Medical Devices

On the 2nd, in order to further improve the filing work for Class I medical devices, the NMPA organized a revision of the former CFDA's "Announcement on Matters Related to the Filing of Class I Medical Devices," forming the "Announcement on Matters Related to the Filing of Class I Medical Devices (Draft for Soliciting Opinions)," which is now open for public comments. (NMPA)

Six-Province Alliance in Guangdong Initiates Centralized Procurement of Common and Chronic Disease Medicines, Covering 42 Varieties and 87 Specifications

On the 1st, the Guangdong Province Pharmaceutical Trading Center released a notice regarding the "Concentrated Volume-based Procurement Document for Common and Chronic Disease Medicines of the Guangdong Alliance." The alliance regions participating in this centralized procurement include Guangdong, Shanxi, Henan, Jiangxi, Inner Mongolia, Xinjiang, and the Xinjiang Production and Construction Corps (specific participating provinces are subject to volume reporting notices). This Guangdong Alliance procurement involves 42 varieties and 87 common and chronic disease medicines. (Guangdong Province Pharmaceutical Trading Center)

Yu Xinwei, member of the National Committee of the Chinese People's Political Consultative Conference: Accelerate the Launch of National Centralized Procurement for Dental Implant Materials

As the Two Sessions are about to convene, Yu Xinwei, a member of the National Committee of the Chinese People's Political Consultative Conference, proposed the following suggestions: First, the national centralized procurement of dental implant materials should be initiated as soon as possible, and it is recommended that dental implants be included in medical insurance as soon as possible. Second, break the import barriers for dental implant materials and accelerate the substitution with domestically produced brands. Third, strengthen the integration of industry, academia, and research, and encourage the integrated development of oral science with emerging industries. Fourth, expedite the training and supply of dental medical personnel. (CCTV News)

Industry Economics Observation

AstraZeneca Strikes Over $700 Million Deal to Treat Fatal Cardiomyopathy

On the 1st, Alexion, a subsidiary of AstraZeneca, announced the completion of an exclusive global collaboration and licensing agreement with Neurimmune for NI006. NI006 is used to treat transthyretin amyloid cardiomyopathy. Under the terms of the agreement, Alexion has obtained the global exclusive license rights for the development, manufacturing, and commercialization of NI006. Alexion paid Neurimmune an upfront payment of $30 million. Neurimmune is also eligible to receive up to $730 million in development, regulatory, and commercial milestone payments, as well as royalties on net sales of future approved drugs. (WuXi AppTec)

LinkRoad Pharmaceuticals Appoints Xun Liu as Chief Technology Officer

On the 1st, Overland Pharmaceuticals announced the appointment of Xun Liu as Chief Technology Officer. Liu will be responsible for the company's global technology operations, including the chemistry, manufacturing, and control businesses for product development and commercialization. (Sina Medicine News)

Former Xi'an Janssen Executive Fan Jie Appointed CEO of MedSci

On the 1st, MedSci announced the appointment of Fan Jie as Chief Executive Officer. Prior to joining MedSci, Fan Jie served as General Manager of Actelion Pharmaceuticals and as a senior executive at Xi'an Janssen. (PharmaCube)

Shaofei Xia, Head of Novartis Oncology and Hematology Division, to Step Down; Position Temporarily Assumed by Wei Wang

On the 1st, Fiona Fang, General Manager of Novartis Oncology (China), announced a personnel change to employees. Xia Shaofei, the current head of the Hematology Business Unit of Novartis Oncology (China), has decided to leave Novartis to pursue external career opportunities. His position will be temporarily assumed by Wang Wei, the current head of the North One Region of the Hematology Business Unit, who will comprehensively manage all work of the marketing and promotion teams within the Hematology Business Unit. (Medical Representative)

Abbott Diagnostics China's New President Replaced, Former Siemens Diagnostics Global President to Join Smith & Nephew

On February 24, 2022, Abbott announced via an internal email that Tony Chan, Abbott's Global Vice President and President of Core Diagnostics in China, had decided to pursue external opportunities. Fanny Chen has been appointed as the President of Abbott's Core Diagnostics in China from within the company and will report to Greg Ahlberg, Senior Vice President of Commercial Operations for Global Core Laboratory Diagnostics. Additionally, Deepak Nath, President of Global Diagnostics and Laboratory Diagnostics at Siemens Healthineers, will join Smith & Nephew in April as the company’s global CEO. (Sina Medicine News)

Ruian Gene Securities Affairs Representative Song Nan Resigns

On the 1st, Oncobiology Gene announced that Song Nan resigned from the position of company's securities affairs representative due to personal reasons. After resignation, he will no longer hold any position in the company, and the resignation report will take effect from the date it is delivered to the company's board of directors. (Corporate Announcement)

Zai Lab Reports Net Loss of $704 Million in 2021, Widening 161.98% Year-over-Year

On the 2nd, Zai Lab announced its 2021 annual report. The company achieved revenue of 144 million US dollars, a year-on-year increase of 194.77%. The net loss attributable to the parent company was 704 million US dollars, with a year-on-year increase in loss of 161.98%. The basic earnings per share were -7.58 US dollars. (Sina Medicine News)

Bayer's sales in 2021 were 44.081 billion euros, an increase of 8.9% year-on-year.

Recently, Bayer announced its 2021 performance. The group's sales reached 44.081 billion euros, representing a year-on-year increase of 8.9%. Of this, prescription drug business sales amounted to 18.349 billion euros, marking a year-on-year growth of 7.4%; over-the-counter product sales reached 5.293 billion euros, increasing by 6.5% year-on-year; EBITDA before special items was 1.19 billion euros, reflecting a year-on-year increase of 6.8%. (Pharma Health Digest)

AbbVie Spends $1 Billion to Acquire Syndesi, Expanding Neuroscience Portfolio

Recently, AbbVie announced the acquisition of Syndesi, headquartered in Belgium, for $1 billion. This acquisition will further strengthen AbbVie's portfolio in neurodegenerative diseases. For this purpose, AbbVie is required to pay Syndesi an upfront payment of $130 million, with additional potential milestone payments of up to $870 million in the future as per the agreement terms. In return, AbbVie gains access to Syndesi’s novel synaptic vesicle protein 2A modulator portfolio, including SDI-118. (Sina Medicine News)

NextRNA Announces Over $56 Million in Financing to Advance Small Molecule Therapies

On the 2nd, NextRNA announced the completion of a $9.3 million seed financing round and a $46.8 million Series A financing round. The funds obtained will be used to enhance its target and drug discovery engine for non-coding RNA, expand the R&D pipeline, and advance the lead projects. (WuXi AppTec)

Huayi Lejian Completes Hundreds of Millions of Yuan in Series A Financing to Advance Clinical Development of Core Pipeline

On the 2nd, Huayi Lejian announced the completion of a Series A financing round worth hundreds of millions of RMB. This round was led by Sequoia China, with participation from Sunshine Insurance, QingSong Capital, and Beijing Life Science Park Venture Capital Fund. Existing shareholders Everbright Holdings, Fruitful Riches, and Huaxing Capital continued their support; Huaxing Capital served as the exclusive financial advisor for this transaction. The proceeds will primarily be used to advance the production, registration, clinical trials, and research of the company's lead gene therapy products, as well as to expedite the development of other products targeting the liver and nervous system. (VcBeat)

Pharmaceutical News and Medical Information

Pfizer's Clostridioides difficile vaccine phase III trial fails

Recently, Pfizer announced that its Clostridioides difficile candidate vaccine PF-06425090 failed to meet the primary endpoint of preventing infection in a pivotal Phase 3 trial. Participants received three doses of the Clostridioides difficile vaccine (n=8766) or placebo (n=8769) at 0, 1, and 6 months. The trial results showed that in terms of the number of people seeking medical attention due to Clostridioides difficile infection, the data for the vaccine and placebo were 0 versus 11, indicating 100% efficacy for the PF-06425090 vaccine. The median and mean durations of Clostridioides difficile infection in patients who received the PF-06425090 vaccine and placebo groups were 1 day versus 4 days, and 3 days versus 16 days, respectively, meaning that patients vaccinated with PF-06425090 experienced 75% and 80% reductions in disease episodes, respectively. (Sina Medicine News)

Ocumension Therapeutics Announces Positive Results from Zerviate Phase 3 Clinical Trial in China

On the 2nd, Nicox announced that its partner in China, Ocumension, had achieved positive results in the Phase 3 clinical trial in China for the allergic conjunctivitis drug Zerviate. Zerviate is a histamine H1 receptor antagonist introduced by Ocumension, which has already been approved by the U.S. FDA for the treatment of ocular itching associated with allergic conjunctivitis. It was reported that the study enrolled 296 patients. The study found that, for the primary efficacy endpoint, OT-1001 was non-inferior to the control drug, and was safe and well-tolerated, with no difference in the proportion of patients experiencing adverse events compared to the control drug. (WuXi AppTec)

Boehringer Ingelheim/Eli Lilly's Empagliflozin Tablets New Indication for Priority Review

On the 2nd, the CDE official website showed that the new indication application for Boehringer Ingelheim/Eli Lilly's empagliflozin tablets to reduce the risk of cardiovascular death or hospitalization due to heart failure in adult patients is proposed to be included in the priority review and approval process, which is expected to accelerate its market launch. (CDE)

Alnylam Announces FDA Acceptance of Lumasiran Supplemental New Drug Application

On August 1, Alnylam announced that the U.S. FDA had accepted the supplemental new drug application for lumasiran, intended to reduce plasma oxalate levels in patients with advanced Type 1 primary hyperoxaluria. Lumasiran is an RNAi therapeutic drug targeting the HAO1 gene, which encodes glycolate oxidase. (WuXi AppTec)

First China-Produced Recombinant Coronavirus Protein Vaccine Granted Conditional Approval for Marketing by NMPA

On the 1st day, the NMPA conditionally approved the marketing registration application for the recombinant novel coronavirus protein vaccine (CHO cell) developed by Anhui Zhifei Longcom Biopharmaceutical Co., Ltd. This vaccine is the first domestically produced recombinant novel coronavirus protein vaccine to be approved in China and is suitable for preventing diseases caused by novel coronavirus infection. (NMPA)

CTI Announces Vonjo Approved by U.S. FDA for Market Launch

On February 1st, the U.S. FDA announced the approval of CTI BioPharma's Vonjo for marketing, to treat patients with myelofibrosis accompanied by severe thrombocytopenia. Vonjo is a novel oral kinase inhibitor that specifically inhibits JAK2, IRAK1, and CSF1R. Because it does not inhibit JAK1, it can avoid potential side effects caused by JAK1 inhibition. (WuXi AppTec)

Antengene XPOVIO^®Approved for marketing in Singapore

On the 1st day, Antengene announced, XPOVIO^®Has obtained marketing approval from the Health Sciences Authority of Singapore for three indications: the treatment of relapsed/refractory multiple myeloma and relapsed/refractory diffuse large B-cell lymphoma. (MedDRA)

Hansoh Pharma's Inebilizumab Injection to Be Approved for Marketing Soon

On the 2nd, the NMPA official website showed that the marketing application of Inebilizumab Injection, a CD19 monoclonal antibody developed by Hansoh Pharma, has entered the administrative approval stage and is expected to be approved for marketing soon for the treatment of neuromyelitis optica spectrum disorders. (NMPA)

ZKT BioPharma's Inhaled Nitric Oxide Expected to Receive Approval for Market Launch Soon

On the 2nd, the NMPA official website showed that the listing application for Zhoji Pharmaceutical's Class 5.1 new drug, Inhalation Nitric Oxide, has entered the approval stage and is expected to be approved soon. Inhalation nitric oxide is a vasodilator that can selectively relax pulmonary blood vessels and, when used with ventilators and other appropriate medications, improve oxygenation in vulnerable neonatal populations. (NMPA)

Marketing Authorization Application for Adalimumab Injection by Junshi Biosciences/Mabwell Biosciences Completed

On the 2nd, Junshi Biosciences released a corporate announcement stating that according to a query on the NMPA website, the marketing authorization application for the Adalimumab Injection developed in collaboration with Mabwell Biotherapeutics for the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriasis has reached the "approval completed - pending certification" stage. This status indicates that the NMPA has completed the review, and the corresponding administrative department is currently preparing the drug registration certificate. (Corporate Announcement)

Baiyun Mountain Branch Company's Tenofovir Disoproxil Fumarate Tablets Obtain Drug Registration Certificate

On the 2nd, Baiyun Mountain released a corporate announcement stating that its branch, Baiyun Mountain Pharmaceutical General Factory, recently received the "Drug Registration Certificate" for Tenofovir Disoproxil Fumarate Tablets approved and issued by the NMPA. Tenofovir Disoproxil Fumarate has the characteristics of strong efficacy and low resistance against the hepatitis B virus and is unanimously recommended by the chronic hepatitis B prevention and treatment guidelines of multiple countries as a first-line drug for treating chronic hepatitis B. It is suitable for treating adult patients with chronic hepatitis B and pediatric patients aged 12 years and above (inclusive); it is also suitable for use in combination with other antiretroviral drugs to treat adult HIV-1 infection. (Corporate Announcement)

Intellia Announces First Patient Dosed in Phase 1/2a Clinical Trial of NTLA-5001

On the 2nd, Intellia announced that NTLA-5001, developed using the company's gene-editing technology-based cell engineering platform, has completed the first patient dosing in a Phase 1/2a clinical trial for the treatment of acute myeloid leukemia. (WuXi AppTec)

NOCIONE HADO approved for clinical use

On the 2nd, Novocure Health announced that the company's BTK inhibitor Orelabrutinib for the treatment of neuromyelitis optica spectrum disorder has passed the NMPA's new drug review for clinical research and has been approved to conduct Phase II clinical trials in China. (Sina Medicine News)

Omeros Corporation's OMS721 Injection Approved for Clinical Use in China

On the 2nd, the CDE official website announced that the OMS721 injection submitted by Omeros has been approved for clinical trials in China, with the proposed indication being IgA nephropathy. (CDE)