Thermo Fisher Acquires Henogen for €725 Million; Aosaikang's Generic Temozolomide for Injection Approved in China

[January 18, 2021 / Pharmaceutical News Overview]Thermo Fisher Acquires Henogen for €725 Million; ZJ Bio-Tech Lists Today; AskPharm’s Temozolomide for Injection Approved...Daily Fresh Pharmaceutical and Medical News: Quick Read Society Keeps You Informed!

Part 1 Policy Brief

Beijing Reports Two New Locally Transmitted Confirmed Cases, Both Residing in Daxing District

From 00:00 to 24:00 on January 17, two new locally transmitted confirmed cases were reported, with no new suspected cases or asymptomatic infections. One new imported confirmed case was reported, with no new suspected cases or asymptomatic infections. One patient was discharged after recovery. Both locally transmitted cases resided in Tiangongyuan Subdistrict, Daxing District. Based on a comprehensive assessment of epidemiological history, clinical manifestations, laboratory tests, and imaging findings, they were diagnosed as confirmed cases on the same day, classified as moderate severity. The imported case had been working in Serbia. The patient departed from Serbia on January 11, transited through Denmark, and arrived at Beijing Capital International Airport on January 12 on Air China flight CA878. Health screening and nucleic acid testing conducted by customs yielded negative results, and the individual was transferred to a centralized quarantine hotel under closed-loop management. The nucleic acid test result on January 17 was positive. Relevant authorities have initiated epidemiological investigations for the aforementioned confirmed cases and implemented control measures in accordance with requirements. (CCTV News)

Heilongjiang Reports 7 New Confirmed Cases and 81 New Asymptomatic Infections

On January 18, CCTV reporters learned from the Heilongjiang Provincial Health Commission that from 0:00 to 24:00 on January 17, 2021, Heilongjiang Province reported 7 new confirmed cases of COVID-19 (4 in Anda City, Suihua; 2 in Beilin District, Suihua City; and 1 asymptomatic infection converted to a confirmed case in Hailun City, Suihua). One confirmed case was cured and discharged from the hospital (Aihui District, Heihe City). There were 81 new asymptomatic infections (74 in Wangkui County, Suihua City; 2 in Qinggang County, Suihua City; 2 in Songbei District, Harbin City; and 3 in Ang'angxi District, Qiqihar City). (CCTV News)

One New Asymptomatic Case Reported in Songyuan, Jilin Province, Detected During the Fourth Round of Nucleic Acid Screening

On January 18, according to a report from “Songyuan Release,” Songyuan City in Jilin Province reported one new asymptomatic infection case between 0:00 and 12:00 today. The individual is a close contact of Asymptomatic Case 1 reported in Songyuan on January 14 and was identified during the fourth round of active nucleic acid testing while under centralized medical observation. The infected person is currently receiving isolated medical observation at a designated hospital in the city. Songyuan City is conducting epidemiological investigations and tracing of close contacts and secondary close contacts, with strict implementation of control measures. (Cailianshe)

False Reporting of All-Negative Results! Third-Party Agency Under Investigation

At 18:00 on January 17, Xingtai City in Hebei Province held a press conference on epidemic prevention and control to provide the latest updates. Rong Yang, member of the Standing Committee of the Xingtai Municipal Party Committee and Head of the Publicity Department, stated that according to reports from Longyao County, sample collection was outsourced to a certain entity in Jinan due to limited local testing capacity. On the 14th, the company falsely reported to the health authorities that all results were negative. On the morning of the 16th, it reported positive samples. Longyao County has immediately activated its emergency response plan, re-sampled the 10 individuals involved, and implemented immediate lockdown measures for the Tobacco Company Family Compound, comprising 19 households. According to a report today by The Beijing News, the third-party testing agency involved in the concealment had been penalized by the National Health Commission in April last year. (Beijing Daily)

Part 2 Industry and Economics Observation

Patent Protection for Xalreto and Eylea Expires, Creating Revenue Gap for Bayer Pharmaceuticals

Bayer’s Two Best-Selling Products—Blood Thinner Xalreto and Ophthalmic Drug Eylea—Face Imminent Patent Expiry Risks. The patent cliffs for these two blockbuster drugs will create a revenue gap for Bayer. The head of Bayer’s pharmaceutical division stated that the company’s current pipeline projects will not be able to offset the decline in revenue in the coming years. (Sina Medical News)

Thermo Fisher Acquires Henogen for €725 Million

Thermo Fisher Scientific Announces Completion of Acquisition of Henogen, Novasep’s Viral Vector Manufacturing Business in BelgiumRecently, Thermo Fisher Scientific announced the completion of its acquisition of Henogen, the viral vector manufacturing business of Novasep, a service and technology provider in the life sciences industry, based in Belgium. The transaction was closed for €725 million in cash. According to reports, Henogen’s operations will become part of Thermo Fisher Scientific’s Pharmaceutical Services business, which falls under its Laboratory Products and Services segment. (Sina Medical News)

Xixiang Technology Completes Angel Round Financing of Nearly RMB 10 Million

On January 18, VCBeta learned that XiXiang Technology announced the completion of its angel financing round, raising nearly RMB 10 million. This round was jointly invested by Shanghai Jiuhe Tang Traditional Chinese Medicine Co., Ltd. and Xiamen Pudao. The funds raised will be used for the research and development of new-generation products and the construction of a digital service system. (VCBeta)

TuoZhen Bio Files for IPO on Nasdaq

Recently, according to the official website of NASDAQ in the United States, TuoZhen Biopharma has submitted an application for listing on NASDAQ to the U.S. Securities and Exchange Commission, with a proposed fundraising amount of $100 million. According to the press release, the joint bookrunners for this IPO application by TuoZhen Biopharma are JPMorgan Chase, Goldman Sachs Group, and Cowen Inc. Established in 2016, TuoZhen Biopharma is a company dedicated to developing novel therapies for chronic liver diseases such as NASH (non-alcoholic steatohepatitis), liver fibrosis, and hepatocellular carcinoma. (Medical Horizon)

Beikang Medical Is About to Go Public

Market sources indicate that Beikang Medical has passed the listing hearing, with plans to raise a maximum of US$250 million (approximately HK$1.95 billion). According to the prospectus, Beikang Medical is a unicorn company in China’s assisted reproductive genetic testing solutions sector and the first Chinese company to possess a high-throughput gene sequencing product line covering the entire reproductive cycle. Public information shows that Beikang Medical’s PGT-A kit can screen embryos for normal development prior to implantation. As the first high-throughput gene sequencing kit approved by the National Medical Products Administration (NMPA), it marks the emergence of a regulated, industrialized genetic testing market for third-generation IVF (PGT) in China. (Sai Bailan)

Zhejiang Zhijiang Biotechnology Makes Stock Market Debut Today, with an Issue Price of RMB 43.22 per Share

On January 18, according to an exchange announcement, Zhejiang Biotech listed on the STAR Market of the Shanghai Stock Exchange today. The company’s stock code is 688317, with an issue price of RMB 43.22 per share and an issue P/E ratio of 189.85 times. (Shanghai Securities News)

Part 3 Pharmaceutical News and Medical Updates

GSK Announces Positive Data for Dostarlimab in dMMR Solid Tumors

On January 16, GSK announced the latest data from Cohort F of the GARNET study, which primarily evaluated the efficacy of dostarlimab in advanced non-endometrial solid tumors with mismatch repair deficiency (dMMR). The findings were presented at the 2021 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium. The results showed an objective response rate (ORR) of 38.7% among patients with dMMR advanced solid tumors treated with dostarlimab. Furthermore, after a median follow-up of 12.4 months, the median duration of response had not been reached, and durable responses were observed across various tumor types. (Sina Medical News)

Haisco: FDA Approves IND Application for HSK-3486 Phase III Clinical Trial in the United States

On January 18, Haisco Pharmaceutical Group announced that its fourth-tier subsidiary, Haisco USA, recently received FDA approval for the Investigational New Drug (IND) application for the Phase III clinical trial of HSK-3486 emulsion for injection, paving the way for the imminent launch of the study. The U.S. Phase III trial will focus on the indication of Induction of General Anesthesia and plans to enroll 351 subjects. The clinical trial application for this indication in Europe is progressing as scheduled, while applications for other indications are also under evaluation and advancing according to plan. (Haisco Pharmaceutical Group Announcement)

The World’s Second 3D-Printed Drug! Triastek’s Product Receives U.S. FDA Approval for New Drug Clinical Trial

Recently, Triastek announced that its first 3D-printed drug product, T19, has received approval from the U.S. FDA for an Investigational New Drug (IND) application. This product is the second 3D-printed drug globally to submit an IND to the U.S. FDA and the first 3D-printed drug in China to enter the registration application stage. T19 is a 3D-printed drug independently designed and developed by Triastek with global intellectual property rights. The product is designed based on the principles of chronotherapy, targeting the circadian rhythm of rheumatoid arthritis symptoms. Patients take T19 before bedtime, allowing the drug concentration in the blood to peak in the morning when symptoms such as pain, joint stiffness, and functional impairment are most severe, while maintaining daytime blood drug levels, thereby achieving optimal therapeutic efficacy. (PharmCube)

Sinovac Biotech's COVID-19 Inactivated Vaccine Approved for Emergency Use in Brazil

On January 17 (local time), ANVISA announced the granting of emergency use authorization in Brazil for CoronaVac, the inactivated COVID-19 vaccine developed by a subsidiary of Sinovac Biotech. The first batch of COVID-19 vaccine recipients in Brazil received the Sinovac vaccine on the same day. At a special meeting held that day, all five directors of ANVISA voted unanimously in favor of the relevant resolution. In addition to CoronaVac, emergency use authorization was also granted on the same day for the COVID-19 vaccine jointly developed by the University of Oxford and AstraZeneca. ANVISA stated that the epidemic situation in Brazil is currently severe. Scientific research data indicate that both vaccines meet the quality and safety requirements for emergency use. (Immediate Pharma News)

Aussencan’s Application for Market Approval of Class 3 Generic Temozolomide for Injection Approved

On January 18, the NMPA website updated its list of approved drugs. Akeso’s Class 3 generic application for Temozolomide for Injection was approved and considered as having passed the consistency evaluation. In January 2019, Hengrui Medicine announced that its Class 3 generic version of Temozolomide for Injection had been approved, marking the first domestic generic approval in China. To date, two manufacturers have passed the consistency evaluation for both the capsule and injection formulations of temozolomide, and the oral immediate-release formulation has been included in the fourth batch of the National Centralized Drug Procurement catalog. (Menet)

Yangtze River Pharmaceutical Group’s Generic Marketing Application for Propofol Medium- and Long-Chain Triglyceride Emulsion Injection (Class 4) Approved

On January 18, the NMPA website announced that Yangtze River Pharmaceutical Group’s Class 4 generic marketing application for Propofol Medium- and Long-Chain Triglyceride Emulsion Injection had been approved and was deemed to have passed the consistency evaluation. Data from Menet shows that Propofol Medium- and Long-Chain Triglyceride Emulsion Injection is a major anesthetic product with sales approaching RMB 2 billion at the terminal level of Chinese public medical institutions, and this product has been included in the fourth batch of national centralized procurement. Currently, there are two lipid emulsion drug delivery systems marketed globally: Propofol Injection (Long-Chain Triglyceride Emulsion) and Propofol Medium- and Long-Chain Triglyceride Emulsion Injection. (Menet)

Jianjin Pharmaceutical’s Bendamustine Hydrochloride for Injection Receives Drug Registration Certificate from the National Medical Products Administration

On January 18, Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (Jianyou Shares) announced that its subsidiary, GenSci Pharmaceutical, had recently received notification from the National Medical Products Administration (NMPA) approving the drug registration certificate for Bendamustine Hydrochloride for Injection. Bendamustine Hydrochloride for Injection is an alkylating agent primarily indicated for the treatment of chronic lymphocytic leukemia and B-cell non-Hodgkin lymphoma. The original innovator product was first launched in the United States in 2008, with CEPHALON as the applicant. It is available in two strengths: 25 mg/vial and 100 mg/vial. The 100 mg strength of the innovator product was approved in China in 2018, while the 25 mg strength has only one generic version marketed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Announcement from Jianyou Shares)

Kelun Pharmaceutical: Medium/Long-Chain Fat Emulsion Injection Passes Generic Drug Consistency Evaluation

On January 18, Kelun Pharmaceutical issued an announcement stating that it had recently received the “Notice of Approval for Supplemental Drug Application” for the chemical drug “Medium- and Long-Chain Fat Emulsion Injection,” approved and issued by the National Medical Products Administration (NMPA). The drug has passed the consistency evaluation of quality and efficacy for generic drugs, providing energy and essential fatty acids for patients requiring parenteral nutrition. Medium- and long-chain fat emulsion injection is the most widely used fat emulsion in clinical practice, offering advantages such as rapid energy supply, efficient nitrogen sparing, and liver protection. It has been extensively recommended by domestic and international guidelines for patients with impaired liver function and those with tumors, among other conditions. (Kelun Pharmaceutical Announcement)

Ruishun Bio: First Allogeneic DNT Cell Therapy for Relapsed/Refractory Acute Myeloid Leukemia Approved for Clinical Trials in China

It is reported that RC1012 Injection, an allogeneic DNT cell product developed by Ruishun Bio, received implicit approval for clinical trials from the Center for Drug Evaluation of the National Medical Products Administration in November 2020. The intended indication is relapsed/refractory acute myeloid leukemia (AML). Derived from healthy donors, this product does not require HLA (human leukocyte antigen) matching and is poised to become the world’s first innovative allogeneic immune cell therapy for relapsed/refractory AML. (Arterial Network)

Huitai Medical: Obtained Two Medical Device Registration Certificates

On January 18, Huitai Medical announced that its wholly-owned subsidiary, Hunan Apte Medical Devices, had recently received two medical device registration certificates issued by the NMPA. The products are named “Anchoring Balloon Dilatation Catheter” and “Guiding Catheter.” Among them, the Anchoring Balloon Dilatation Catheter is an innovative medical device that pioneers the use of balloon anchoring for catheter exchange within guiding catheters in China. (Huitai Medical Announcement)

Boehringer Ingelheim and ViGeneron Collaborate to Develop Novel AAV Vectors

Boehringer Ingelheim and ViGeneron announced a collaboration today to develop novel adeno-associated virus (AAV) vectors for next-generation gene therapies through ViGeneron’s proprietary VELP™ platform. This new partnership combines Boehringer Ingelheim’s expertise in disease mechanism research and gene therapy development with ViGeneron’s specialization in viral library construction and high-efficiency in vivo AAV screening, thereby providing patients with potentially safer and more effective novel AAV serotypes. (PR Newswire)

Dano Pharma Partners with Johnson & Johnson to Co-Develop Novel Drugs for Nontuberculous Mycobacteria

On January 18, Danuo Medicine announced a collaboration with Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Under the agreement, Janssen will leverage Danuo’s multi-targeted conjugate molecule drug discovery platform to jointly identify novel combination therapies for the treatment of nontuberculous mycobacterial (NTM) infections. According to the Guidelines for the Diagnosis and Treatment of Nontuberculous Mycobacterial Diseases (2020 Edition), NTM refers to mycobacteria other than the Mycobacterium tuberculosis complex and Mycobacterium leprae. These organisms most commonly affect the lungs, presenting with clinical manifestations similar to those of tuberculosis, including systemic toxic symptoms and local tissue damage. The incidence is higher among patients with underlying pulmonary conditions or immune system disorders. (BioExplorer)

Developing Innovative Ophthalmic Gene Therapies: ViGeneron Enters Research Collaboration with Daiichi-Sankyo

On January 18, ViGeneron announced a research collaboration with Daiichi Sankyo. The two parties will leverage ViGeneron’s proprietary, engineered adeno-associated virus (AAV) vectors to deliver a novel therapeutic protein, with the aim of developing a gene therapy for common ophthalmic diseases. Reportedly, this vgAAV technology enables efficient transduction of target cells via intravitreal injection, thereby facilitating effective lateral diffusion and minimizing the risk of collateral damage associated with traditional subretinal injections. (Medical Observer)