Company News
| Multinational Pharmaceuticals News
Pfizer will acquire Biohaven Pharmaceuticals, a migraine drug manufacturer, for approximately US$11.6 billion in cash, and Pfizer will obtain the right to use the drug Rimegepant, which has been approved by Biohaven. Rimegepant belongs to a migraine drug called a calcitonin gene-associated peptide (CGRP) inhibitor. Pfizer currently holds a 2.6% stake in the company. Rimegepant was approved for the treatment of acute migraine attacks in 2020, and received wider approval to prevent migraine attacks in May last year. The therapy brought in $462.5 million in sales in 2021.
Australian biotech company CSL said it could not close the deal by June 2022 as regulators need additional months to review its acquisition of Vifor Pharma, as previously expected. CSL's acquisition of Swiss pharmaceutical company Vifor Pharma for US$11.7 billion is the largest merger and acquisition transaction in the biopharmaceutical industry in 2021. Some antitrust regulators, such as the Federal Trade Commission, the European Competition Commission and the Swiss Acquisition Commission, have not ruled on the deal.
Omron (OMRON Group) has released a new long-term vision - "Shaping the Future 2030". To realize this vision in the healthcare business, OMRON Healthcare Co., Ltd., headquartered in Katsuhiro, Kyoto Prefecture, has put forward a long-term vision - "Going for ZERO, preventing health care and making the world healthier", and is committed to developing new equipment and services that can meet the expectations of consumers, medical professionals and the entire society.
| Chinese pharmaceutical company dynamics
Junshi Biologics decided to establish a clinical R&D department. The newly established clinical R&D department includes the Medical Science Department, Data Science Department, Clinical Pharmacy Department, Quality Assurance Department, Pharmacy Affairs Department, Medical Affairs Department and Clinical Operation Department. The heads of all functional departments report directly to Zou Jianjun, deputy general manager and global R&D president. The former clinical development department was renamed the Clinical Operations Department, and was led by Huang Yihui's senior vice president. All functional teams of the former clinical development department will belong to the Clinical Operations Department. At the same time, the drug safety team, department one and department two of clinical affairs, and the medical writing team originally affiliated to the Data Science Department will belong to the Clinical Operations Department.
Baorui Pharmaceutical announced that Baorui Biotechnology, a subsidiary of large molecule drug CDMO, has officially entered its army. Baorui also announced that Baorui Biotechnology has obtained Eden Biotechnology's assets in Taiwan for US$50 million (about NT$1.5 billion), including Taiwan factories, laboratories and all talent pools. At the same time, it signed an MSA OEM agreement with Eden Biotechnology. In addition to Eden's own product portfolio, the production and OEM orders of existing customers will also be transferred to Baorui Biotechnology in the future.
Kepu Biological Announcement, it plans to invest in the construction of Kepu Medical Science Park. The project is expected to have a total investment of about 1.512 billion yuan. The project planning and construction content includes high-end biomedical experimental consumables and in vitro diagnostic raw materials production base, new crown epidemic prevention testing supporting reagent production base, biological instrument R&D intelligent manufacturing base, new disinfection and protective supplies production base, packaging material production base, Kepu Innovation Research Center, inspection and nursing and other medical talent training and high-end academic exchange center, biotechnology industry chain enterprise introduction and incubation service base, and other production and life-related supporting facilities.
Ruishi Biologics, a subsidiary of Hengrui Medicine, announced that it has completed a Series A financing of nearly US$100 million. The funds from this round of financing will be used to promote the research and global clinical development of innovative drugs in the fields of autoimmune and inflammatory diseases. Ruishi Biotech was jointly established by Hengrui Medicine in incubation of US$100 million in early 2018. It was personally chairman of Sun Piaoyang , focusing on the research and development of new drugs in the fields of autoimmune diseases such as inflammatory digestion, skin, and nerves.
Medical beauty company Gizi Bio submitted its listing prospectus. Founded in Shaanxi in May 2000, Juzi Bio is a high-tech enterprise dominated by genetic engineering technology, biomedical materials and tissue engineering. It is currently one of the largest recombinant collagen manufacturers in the world.
| Executive News
Moderna's new CFO resigned just two days after taking office. Moderna announced that George Gomez, who has just taken up new position, has left the company. The change is related to an investigation disclosed by Gomez's former boss this week.As the price of termination of the labor contract, Moderna will pay a series of severance payments to Gomez, who has been on duty for two days, including his annual salary of $700,000 for the whole year.
JP Medical Technology has appointed Kurt Van den Bosch as Chief Financial Officer. Previously, Mr. Van den Bosch was the regional vice president of the medium-sized markets in Johnson & Johnson MedTech Europe, Middle East and Africa. In 1990, he joined Janssen Pharmaceuticals in Belgium.
Legend Biotech announced that certified public accountant Lori Macomber was promoted to Chief Financial Officer (CFO). Ms. Macomber took over the position of Dr. Huang Ying, who has also served as CFO and CEO since September 2020. Dr. Huang will continue to serve as CEO of Legend Biotech.
Beihai Kangcheng appointed Ms. Li Ping as Senior Vice President of Clinical Development and Operations. Previously, she served as vice president of clinical development at Connect Biologics. Prior to this, she served as Executive Director of the Clinical Operations Department of Shanghai Haihe Pharmaceutical Co., Ltd. and Director of Shi Weiya China Medical and Science Affairs Department. Ms. Li Ping also served as the director of Takeda China Medical Affairs Department, the head of Bayer Medical Affairs Department, the senior medical manager of Xi'an Janssen, and the manager of Shanghai Roche Medical Department. Ms. Li Ping started her career at Fuwai Hospital, Chinese Academy of Medical Sciences, and worked as a cardiologist.
Feng Yi, chairman of China Resources Shuanghe Company, will no longer serve as director, chairman of the company's 9th board of directors, and chairman of the board of directors' strategic committee since May 11 because he has reached the statutory retirement age of . The company elects the company's director and president Yu Shunting to perform its position as chairman.
| Financial report
Bayer Group (Bayer) announced its first quarter results for 2022. Quarterly sales were 14.639 billion euros compared with 12.328 billion euros in the same period last year. Among them, the sales of crop science business was 8.447 billion euros, compared with 6.646 billion euros in the same period last year. The pharmaceutical business sales amounted to 4.624 billion euros, compared with 4.365 billion euros in the same period last year. The consumer health care business sales amounted to 1.512 billion euros, compared with 1.252 billion euros in the same period last year. profit before interest, tax, depreciation and amortization, excluding special items reached 5.251 billion euros, compared with 4.118 billion euros in the same period last year. Net profit was 3.291 billion euros, compared with 2.089 billion euros in the same period last year.
German pharmaceutical and chemical giant Merck Group released its financial report saying that after-tax profit in the first quarter of 2021 was 884 million euros, an increase of 18% from 748 million euros in the same period last year. Net sales rose 12% in the first quarter to €5.2 billion, with all business units driving organic growth . EBITDA (EBITDA) rose 7.8% to 1.63 billion euros, compared with 1.51 billion euros a year ago. Among them, net sales of the life sciences business increased by 9.7% organically to 2.445 billion euros. Net sales of the pharmaceutical and health business increased by 6.5% organically to 1.795 billion euros.
BioNTech released its first-quarter financial report, with revenue of 6.375 billion euros, a year-on-year increase of 211% from 2.048 billion euros in the same period last year; net profit reached 3.699 billion euros, a year-on-year increase of 228% from 1.128 billion euros in the same period last year.
Inmena released its first quarter results report for fiscal year 2022. Revenue in the first quarter of 2022 was US$1.22 billion, an increase of 12% from the same period last year. Net income was US$86 million, compared with US$147 million in the same period in 2021. The company acquired GRAIL on August 18, 2021. GRAIL had revenue of US$10 million in the first quarter of 2022 and had an operating loss of US$172 million.
Takeda Pharmaceutical (Takeda Pharmaceutical) announced its fiscal year results (April 2021-March 2022). The annual revenue was 3569.06 billion yen, compared with 3197.812 billion yen last year. The operating profit for the fiscal year was 460.844 billion yen, compared with the previous year of 509.269 billion yen. The net profit attributable to shareholders in the fiscal year was 230.059 billion yen, compared with the previous year of 376.005 billion yen. Takeda's net loss in the fourth quarter was 11.4 billion yen, compared with a net profit of 197.1 billion yen in the same period last year. Revenue in the fourth quarter increased by 13% year-on-year to 873.3 billion yen.
Zai Lab announced its financial results for the first quarter of 2022. Total revenue was US$46.7 million for the three months ended March 31, 2022, compared with US$20.1 million for the same period in 2021. The net loss was US$82.4 million, compared with the net loss in the same period of 2021 of US$232.9 million.
Product/R&D Dynamics
| Vaccine
Kangtai Biologics passed EU QP audit quality management system met the EU GMP standard. Shenzhen Kangtai Bioproducts Co., Ltd. The adenovirus vector COVID-19 vaccine production base located in Shenzhen has obtained a statement of conformity issued by the EU quality authorized person (QP). This marks that the production base and quality management system of the Kangtai Bio-Adenoviral Vector New Coronavirus Vaccine has reached the EU GMP standard, which can ensure the high-quality development and commercial production of vaccines.
Wantai Biotechnology issued an announcement that the bivalent human papillomavirus vaccine (Escherichia coli) ("bivalent HPV vaccine") independently developed by the company's wholly-owned subsidiary Xiamen Wantai Canghai Biotechnology Co., Ltd. , obtained the marketing authorization approval of the Moroccan Ministry of Health and Social Security.
KM Biologics ( Kumamoto City ), a pharmaceutical company under the Meiji Group in Japan, announced that the final stage of clinical trials for the new crown vaccine under development will be launched at the end of April, and it is planned to target 1,500 people aged 18 to 40 in Japan and the Philippines, and will continue until November 2023. In addition, clinical trials targeting children have also begun.
| New coronavirus drug
Boan Bio's second-generation broad-spectrum neutralizing antibody is effective against various new coronavirus mutations such as Omicron. BA7208, a second-generation broad-spectrum neutralizing antibody for the treatment of new coronavirus pneumonia (COVID-19), independently developed by Boan Bio, a subsidiary of Green Leaf Pharmaceutical Group, has made important progress: Through the evaluation of neutralization activity based on pseudovirus, BA7208 maintains high-severity and activity for 11 viral variants, among which the IC50 values for Omicron subtype variants reached 2-5 ng/mL. In addition, BA7208 can also maintain high school and activity against the emerging BA.3, BA.4, BA.5 and BA.2.12.1.
The Ministry of Innovation and Development of the Republic of Uzbekistan and the Central Asian Drug Research and Development Center of the Chinese Academy of Sciences/China-Ukrainian Medical Science and Technology City jointly held a press conference on "The original innovative drug Renmindevir (VV116) for the treatment of COVID-19 and its therapeutic effects" at the News Center of the Ministry of Innovation and Development of Ukrainian. Currently, Renmindevir has been listed on Uzbekistan . The product name is Mindvy, with a price of US$185, which is approximately RMB 1,243. Junshi stated that Renmindevir's market in Uzbekistan is the equity area of the partner Wangshan Wangshui, and is operated by Wangshan Wangshui Biopharma Co., Ltd. (Wangshan Wangshui).
Zhongsheng Pharmaceutical holding subsidiary Zhongsheng Ruichuang oral anti-novel coronavirus 3CL protease inhibitor Class 1 innovative drug RAY1216 tablets was accepted by National Medical Products Administration and received the "Acceptance Notice". Preclinical studies have shown that RAY1216 is a broad-spectrum, powerful clinical candidate compound against the new coronavirus, has a significant inhibitory effect on the new coronavirus 3CL protease, and has efficient in vitro inhibitory activity on different new coronavirus variant strains (wild strains, Alpha, Beta, Delta, Omicron).
| Broad-spectrum antiviral drug
Hyundai Bioscience said that CP-COV03 is a broad-spectrum virus treatment drug that can be used for various viruses, including the new coronavirus. The company has recruited confirmed patients of the new coronavirus who participated in the dosing trial and entered the Phase II clinical trial of the antiviral oral drug candidate CP-COV03. If the effective performance of CP-COV03 against the novel coronavirus is confirmed in this clinical trial, the world's first broad-spectrum antiviral drug that can be used in the novel coronavirus and its variants, influenza , hepatitis, AIDS, Ebola , herpes and other viruses that plague humans.
| Oncology drug
Hengrui Medicine's international multicenter phase III clinical trial (SHR-1210-III-310) for injectable carrilizumab (Erica) with apatinib mesylate tablets (Etan) was determined by the Independent Data Supervision Committee (IDMC) to determine the main research endpoint results to meet the preset efficiency standards of the plan. At present, the application for marketing authorization for carrilizumab combined with apatinib ("Double Irrigation" program) for first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received systematic treatment has been accepted by the China National Drug Administration. Hengrui Medicine also plans to submit a communication application for the launch of new drugs to US Food and Drug Administration (US FDA) in the near future.
First Affiliated Hospital of Soochow University is conducting a "one-arm, multicenter, open clinical study to evaluate the effectiveness of FKC876 in adult patients with relapsed/refractory indolent non-Hodgkin's lymphoma (iNHL)." It is expected that 32 subjects will be recruited from 10 centers in China. The FKC876 injection of this clinical trial is provided by Fosun Kate Biotechnology Co., Ltd. It is a CD19-targeted autologous T cell immunotherapy with CD3ζ/CD28 signaling pathway and genetic modification. The common name of drug is Achillensaic injection. The purpose of this clinical trial is to add new indications based on the approved indications for marketing in China.
| HIV
GSK (GSK) announced an innovative single-pill dual-drug HIV treatment planDoweito (generic name: lamivudine dotetravir tablets) expanded indications has been officially approved by the China National Medical Products Administration as a complete solution for the treatment of HIV-1 adults and adolescents over 12 years old who have achieved virological inhibition. Duoweito was approved for the initial treatment of HIV-infected adults in March 2021.
| Alzheimer's disease
Eicai Co., Ltd. and Bijian Company announced that Eicai has completed the rolling submission of a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) under the rapid approval channel. Lecanemab is a fibrillary antibody for the research drug anti-beta amyloid (Aβ) fibrillary antibody (BAN2401) used to treat mild cognitive impairment (MCI) and mild AD (collectively referred to as early AD) caused by Alzheimer's disease (AD), confirming the presence of amyloid lesions in the brain. Eisai has requested priority review for completed rolling submissions. Eisai may submit a full approval application for lecanemab to the FDA in fiscal year 2022.
Green Valley Pharmaceutical original international phase 3 clinical trial of the new drug Phase 9 (Ganlute Sodium Capsules; codename: GV-971) for the treatment of Alzheimer's disease (AD) has been stopped. Five clinical trial centers have confirmed the news, and four clinical trial centers said that the trial has been stopped due to supply chain problems; another clinical trial center said that this has nothing to do with the supply chain.
|Vinous thrombosis
Bayer (Bayer)New drug marketing application for rivaroxabangan suspension has been officially approved. According to the priority review announcement of the Drug Review Center of the China National Medical Products Administration (CDE), the application is intended for the treatment of venous thromboembolism (VTE) after starting standard anticoagulation treatment in full-term neonatal, infant, children, and adolescents under 18 years old and preventing the recurrence of VTE. Rivaroxaban was discovered by Bayer . Bayer is currently jointly developing the drug with Janssen, a subsidiary of Johnson & Johnson.
| Ophthalmic drug
The official website of China National Medical Products Administration (NMPA) has announced that a new drug called cyclosporine eye drops (III) submitted by the global eye care company Santen Pharmaceutical (Santen) has obtained approval for the marketing. This is a ophthalmic inflammation treatment drug Verkazia (ciclosporin), which was previously included by NMPA in the list of new overseas drugs urgently needed for clinical practice and priority review. The indication is: used to treat severe spring corneal conjunctivitis in children and adolescents over 4 years old. Hovione, a leader in spray drying in
, announced an exclusive licensing agreement with Jixing Pharmaceuticals Co., Ltd. for the preclinical stage ophthalmic project JX08. Under the license agreement, Jixing will acquire global rights to JX08 and lead the full life cycle development from preclinical to commercialization.
| Thrombocytopenia
Sansheng Pharmaceutical announced that a multi-center, randomized, double-blind , placebo-controlled study that evaluates the safety, effectiveness and pharmacokinetics of recombinant human thrombocytopenia (ITP) in children or adolescents, "has reached the preset primary endpoint. When first-line treatments such as glucocorticoid or intravenous immunoglobulin are ineffective and still require treatment, they will enter second-line treatment. Platelet-promoting drugs such as Tebio are the first choice second-line therapeutic drugs recommended by China's ITP guidelines. The company plans to submit a new drug marketing application to National Drug Administration in the near future.
| Other
Boehringer Ingelheim is launched on the new horse stem cell product RenuTend. Boehringer Ingelheim’s innovative product, RenuTend, has now been approved in Europe to market and is the world’s first product for enhanced healing of tendon and suspension ligament injuries. RenuTend is administered through intralesional injection and is the second horse stem cell product after Arti cellFORTE. Arti cellFORTE has been previously approved for the treatment of mild and moderate recurrent claudication in horses caused by nonpurulent joint infection.
Geli Pharmaceuticals Co., Ltd. announced that its ASC22 (enwolizumab) clinical trial application has been approved by the U.S. Food and Drug Administration (FDA) for immune reconstruction/functional cure indications in people infected with human immunodeficiency virus type 1 (HIV-1).
| Detection reagent
PerkinElmer launches the global exclusive newborn screening detection kit. PerkinElmer, a global technology leader in the field of neonatal screening, has launched a new generation of tandem mass spectrometry detection kit NeoBaseTM2. This testing kit (Guoji Predictions 20223400429) has exclusive global testing indicators and disease coverage, and can accurately, quickly and conveniently screen more than 40 neonatal genetic metabolic diseases, providing strong support for timely and effective diagnosis and targeted treatment.
New Glyco Biotechnology developed a new glycated albumin assay kit is available. Compared with the commonly used single BCG method for albumin detection, this product can provide two versions: GA-ALB (BCG) and GA-ALB (BCP). The BCP version can effectively enhance the credibility of the results in patients with hypoalbuminemia and can avoid the impact of ascorbic acid and high-calorie amino acid infusion on the test results.
| Medical Devices
2022, Beckman , a subsidiary of Danaher , launched a feature-rich 3-liter desktop centrifuge -- Allegra V-15R refrigerated desktop centrifuge. The Allegra V-15R enhanced safety features include automatic rotor identification and use cycle counting to help lab administrators make smarter decisions about rotor maintenance and retirement. Biosafety rotors provide dual protection of airtight and watertight, further eliminating the risk of leaking harmful substances such as aerosols into the environment and threatening the safety of experimental personnel.
Shandong Luoxin Pharmaceutical Group Co., Ltd., a subsidiary of Luoxin Pharmaceutical, signed a cooperation agreement with Shanghai Anhan Medical Technology Co., Ltd., a wholly-owned subsidiary of Anhan Technology (Wuhan) Co., Ltd. . Luoxin Pharmaceutical has become the general agent of the innovative medical device registered by Anhan Technology - the gastrointestinal vibration capsule system (Vibrabot, Weitong Capsule") in mainland China. Anhan Technology is an internationally leading high-tech enterprise focusing on the research and development, production and operation of innovative medical devices in the field of gastrointestinal health.
