Hengrui Pharma Appoints New CEO; Enhertu Approved for Second-Line Breast Cancer Treatment

[Pharmaceutical News Overview on May 5, 2022] Viatris to Sell Biosimilar Business; Former Chairman of Genscript, Fangliang Zhang, Receives No-Indictment Decision from Prosecutors; I-Mab, Sinovac Biotech, Genetron Holdings and 88 Other Companies Listed on the Provisional List of the Holding Foreign Companies Accountable Act… For the latest pharmaceutical news and medical information, follow Speed Reading Society!

Policy Brief

CDE Releases 2 Guiding Principles Involving Traditional Chinese Medicine Compound Formulations and the Evidence System for Registration Review

Recently, the CDE official website released the "Guiding Principles for Clinical Development of New Traditional Chinese Medicine Compound Formulations Based on Human Experience (Trial)" and the "Guiding Principles for Communication and Consultation under the 'Three-Combination' Registration Review Evidence System (Trial)" to promote the establishment of a TCM registration review evidence system that integrates TCM theory, human experience, and clinical trials. (CDE)

Beijing Aerospace General Hospital Fails to Implement Prevention and Control Work as Required; Relevant Personnel Under Investigation

On May 5th, at the 325th press conference on the prevention and control of the novel coronavirus pneumonia in Beijing, Li Ang, deputy group leader of the Inspection and Testing Working Group of Beijing's COVID-19 Prevention and Control Leading Group, deputy director of Beijing Municipal Health Commission, and spokesperson, introduced that recently, one COVID-19 positive patient was received at the fever clinic of Beijing Aerospace General Hospital. Before the nucleic acid test result was reported, the patient left the observation area and entered the general outpatient area, causing the hospital’s outpatient areas (except for the emergency department) to be sealed off. After investigation and evidence collection, it was found that the hospital did not take responsibility for implementing its own unit’s infectious disease prevention and control work as required, violating relevant provisions of the "Law of the People's Republic of China on the Prevention and Treatment of Infectious Diseases." Health supervision and law enforcement officers have issued a supervisory opinion letter to the hospital on the spot, ordering the hospital to immediately correct its illegal behavior. The hospital has been given a public reprimand, a warning as an administrative penalty, and a negative practice point accumulation treatment. Relevant staff members who bear responsibility will be investigated. (The 325th Press Conference on the Prevention and Control of the Novel Coronavirus Pneumonia in Beijing)

Industry Observation

Hengrui Medicine Latest Appointment: Former Deputy General Manager Dai Hongbin Promoted to General Manager

On the 5th, Hengrui issued an announcement. According to the needs of business development, Mr. Dai Hongbin was appointed as the General Manager of the company upon the nomination of Chairman Sun Piaoyang. The term of office will be from the date of approval by the board of directors until the end of the term of this board of directors. Mr. Dai Hongbin joined Hengrui immediately after graduating from university and has been with the company for 22 years. Since July 2000, he has served as Director of the Office and Board Secretary. Starting from April 2013, he served as the company's Deputy General Manager, and from January 2020, he has been serving as a Director and Deputy General Manager of the company. (Corporate Announcement)

Genscript's Former Chairman Zhang Fangliang Receives Decision of No Prosecution from the Prosecution

Recently, GenScript announced that the former director, former chairman and former CEO of the company, as well as the former director, former chairman and former CEO of Legend Biotech, Zhang Fangliang, has been decided not to be prosecuted by the procuratorate. The company, its subsidiaries, and related individuals will not bear any criminal responsibility for the investigation. In addition, Zhang Fangliang has been appointed as a non-executive director of the company, effective from May 2nd. (Corporate Announcement)

Viatris to Sell Biosimilar Business

Recently, Biocon Biologics Ltd. (BBL), an Indian company, announced that it has signed a definitive agreement with Viatris. If the closing conditions (approval from regulatory authorities) are met, the acquisition of Viatris' biosimilar business could be completed as early as this quarter. Previously, Viatris announced the sale of its biosimilar business to BBL for $3.335 billion. (Siyi Club)

88 Companies Including I-Mab, Sinovac, and Genetron Are Added to the Provisional List of the Holding Foreign Companies Accountable Act

On April 4, the U.S. Securities and Exchange Commission (SEC) added a sixth batch of 88 companies to the provisional list under the Holding Foreign Companies Accountable Act (HFCAA), with the deadline for submitting evidence to be removed from the list set for May 12. Among them, biopharmaceutical companies included: Gracell Biotechnologies, Adagene, 111 Inc., Burning Rock Biotech, I-Mab, Genetron Holdings, Concord Medical Services, and Sinovac Biotech. (Sina Medicine News)

Novartis Reports 16% Year-over-Year Growth in Net Sales for Q1 in China

Recently, Novartis released its Q1 2022 financial report. The report shows that Novartis Group's net sales increased by 5% year-on-year to USD 12.5 billion in Q1. Among this, the net sales in China grew by 16% year-on-year to USD 880 million. Meanwhile, Novartis’ innovative drug R&D pipeline has also made significant new progress. (MedView)

Pfizer's Total Revenue in Q1: $25.7 Billion

Recently, Pfizer announced its Q1 performance. In Q1, Pfizer's total revenue was $25.7 billion, a year-on-year increase of 82%. Among this, the income from the COVID-19 vaccine Comirnaty was $13.2 billion, and the income from the oral drug Paxlovid was $1.5 billion. Excluding the contribution of COVID-19 products, Q1 revenue increased by 2%. (Sina Medicine News)

Biogen's Total Revenue in Q1: $2.523 Billion, Down 6% Year-over-Year

Recently, Biogen announced its Q1 2022 financial report, with total revenue of $2.523 billion, a year-on-year decrease of 6%. Among this, the sales of Aduhelm (aducanumab), the Alzheimer's drug that has sparked much controversy, were $2.8 million in Q1. (PharmaCube)

Lilly's Q1 revenue was $7.81 billion

Recently, Eli Lilly announced its financial report for the first quarter of 2022. According to the report, Eli Lilly's revenue in the first quarter was 7.81 billion US dollars, increasing by 15% year-on-year. (MedView)

$300 Million Upfront Payment: Gilead Collaborates to Develop Natural Killer Cell Therapy

Recently, Gilead and Dragonfly Therapeutics jointly announced that they have reached a research and development collaboration to advance a series of Dragonfly's immunotherapies based on innovative natural killer (NK) cell engagers for oncology and inflammatory indications. NK cell engagers represent an innovative mechanism of action with the potential to treat a wide range of cancer types. Under the agreement, Gilead will obtain the development rights to the investigational immunotherapy DF7001 targeting 5T4 and will also gain the option to acquire the research and development rights to other candidate therapies developed using Dragonfly's TriNKET technology platform. Gilead will pay $300 million upfront, and Dragonfly is also eligible to receive various milestone payments. (WuXi AppTec)

$670 Million Boosts AI Development for Innovative Therapies: Lilly Reaches R&D Collaboration

Recently, Genesis Therapeutics announced a collaboration with Eli Lilly to leverage Genesis' artificial intelligence (AI) drug discovery platform to identify innovative therapies for up to five targets across multiple therapeutic areas. Under the agreement, scientists from Genesis and Eli Lilly will jointly use Genesis’ AI drug discovery platform to develop potential “first-in-class” and “best-in-class” drug candidates for three targets. Genesis will receive an upfront payment of $20 million, and Eli Lilly has the option to add two additional targets. Genesis is eligible to receive total upfront and milestone payments of up to $670 million. (WuXi AppTec)

Betta Pharmaceuticals Obtains Exclusive Development and Commercialization Rights for EYP-1901 in China

On the 5th, Beta Pharma announced that on May 4th, the company signed an "Expanded License Agreement" with EyePoint Pharmaceuticals, Inc. for the exclusive cooperation in the development and commercialization of EYP-1901 in China (including Hong Kong, Macao, and Taiwan). At the same time, Equinox, a holding subsidiary of the company, revised the "Exclusive License Agreement" with EyePoint, granting EyePoint the exclusive rights to develop vorolanib for all ophthalmic indications administered locally outside of China (including Hong Kong, Macao, and Taiwan), including diabetic macular edema (DME). (Corporate Announcement)

Over $200 Million! Hansoh Introduces Small Molecule Anti-Tumor Drug HIF-2α Inhibitor

Recently, Hansoh Pharmaceutical Group announced that its wholly-owned subsidiary, Hansoh (Shanghai) Health and Jiangsu Hengsen Pharmaceuticals (collectively referred to as the "licensees"), entered into an exclusive licensing agreement with NiKang Therapeutics Inc. Under the licensing agreement, the licensees have obtained an exclusive license from NiKang Therapeutics to develop and commercialize NKT2152 for cancer treatment in China (including Hong Kong, Macao, and Taiwan). The licensees will be responsible for the development, regulatory approval, and commercialization of NKT2152 in China and will pay an upfront fee of $15 million and potential milestone payments of up to $203 million for development, registration, and sales-based commercial milestones, as well as tiered royalties based on net sales. (PharmaCube)

Amphista Collaborates with Bristol-Myers Squibb and Merck Respectively

Today, Amphista Therapeutics announced separate research collaborations with Bristol Myers Squibb and Merck. Based on its unique protein degrader discovery platform, the company aims to develop a new generation of protein degradation therapies. In the collaboration with Merck, the two companies will develop small molecule protein degraders targeting three specific sites in the fields of oncology and immunology. Amphista is eligible to receive up to $1 billion in upfront and milestone payments. In the partnership with Bristol Myers Squibb, both parties will collaborate to discover and develop small molecule protein degraders. Amphista will receive a $30 million upfront payment and is eligible for $1.25 billion in milestone payments. (WuXi AppTec)

New Player Receives $100 Million Boost to Develop Next-Generation Complement Therapies for Autoimmune Diseases

Recently, Dianthus Therapeutics announced the completion of a $100 million Series A financing round. The funds will be used to expand the company’s team, advance its lead project DNTH103 into clinical trials, and accelerate the development of pipeline projects for the treatment of severe and rare autoimmune diseases. DNTH103 is a next-generation monoclonal antibody that selectively targets the activated form of the complement C1s protein. It may allow for lower dosing and reduced frequency of subcutaneous injections. (WuXi AppTec)

Pharmaceutical News and Medical Information

AbbVie's JAK Inhibitor Receives FDA Approval for Expanded Indications

Recently, AbbVie announced that the U.S. FDA has approved the expansion of the indication for its JAK inhibitor Rinvoq (upadacitinib) to treat adult patients with active ankylosing spondylitis. These patients are intolerant to one or more tumor necrosis factor (TNF) blockers or have not achieved sufficient response. The press release noted that this is the fifth indication Rinvoq has received in the field of chronic immune-related diseases. (WuXi AppTec)

Second-Line Treatment for Breast Cancer: AstraZeneca/Daiichi Sankyo's Key ADC Approved by FDA

Today, the FDA's official website showed that the FDA has approved the expansion of the indication for Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate (ADC) jointly developed by AstraZeneca and Daiichi Sankyo, to treat patients with unresectable or metastatic HER2-positive breast cancer who have previously received treatment with an anti-HER2 targeted therapy. (FDA)

Junshi Biosciences PD-1 Receives FDA Complete Response Letter, Launch Delayed

Recently, Junshi Biosciences announced that the U.S. FDA has issued a complete response letter regarding the Biologics License Application (BLA) for PD-1 toripalimab in combination with gemcitabine/cisplatin as a first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma and as a monotherapy for second-line or later treatment of recurrent or metastatic nasopharyngeal carcinoma after platinum-containing therapy. The response letter requests a change in quality control procedures. Junshi plans to meet directly with the FDA and expects to resubmit the BLA before mid-summer 2022. The letter mentioned that the pending on-site inspection has been delayed due to travel restrictions related to the COVID-19 pandemic. The specific timing for the on-site inspection will be announced separately. (Company Announcement)

FDA Rejects HUTCHMED's Surufatinib Marketing Application

Recently, Hutchmed announced that the U.S. FDA has issued a complete response letter regarding the new drug application for surufatinib for the treatment of pancreatic and non-pancreatic neuroendocrine tumors. The FDA believes that the current data package, based on two successful Phase III studies in China and one U.S. bridging study, is not sufficient to support the drug's current approval in the United States. The complete response letter indicates that more international multicenter clinical trials (MRCT) representing the U.S. patient population are needed to support U.S. approval. (Corporate announcement)

FDA Approves Innovative Combination Therapy to Eradicate Helicobacter Pylori Infection

Recently, Phathom Pharmaceuticals announced that the U.S. FDA has approved Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin triple combination) and Voquezna Dual Pak (vonoprazan, amoxicillin dual combination) for marketing to treat Helicobacter pylori infections in adults. (WuXi AppTec)

Humanwell Healthcare's Subsidiary Receives Tentative FDA Approval for Tapentadol Tablets

On the 5th, Humanwell Healthcare announced that its holding subsidiary, Humanwell Pharmaceutical US, Inc., received a tentative approval from the U.S. FDA for its Tapentadol Tablets. Tapentadol Tablets are used to treat acute pain. In 2020, Yichang Humanwell Pharmaceutical USA submitted the ANDA application for Tapentadol Tablets, with cumulative R&D investment amounting to approximately 15 million RMB. (Corporate Announcement)

FDA Approves First In Vitro Diagnostic Test for Early Detection of Alzheimer's Disease-Related Amyloid Deposits

U.S. FDA announced today the approval of the first in vitro diagnostic test for the early detection of amyloid plaques associated with Alzheimer's disease. The Lumipulse G β-Amyloid Ratio (1-42/1-40) assay, developed by Fujirebio Diagnostics, is intended for use in adult patients aged 55 and older who exhibit cognitive impairment and are being evaluated for Alzheimer’s disease or other causes of cognitive decline. (WuXi AppTec)

Enhanced Therapy Persistence: Differentiated CAR-T Therapy Receives FDA Regenerative Medicine Advanced Therapy Designation

Recently, Autolus Therapeutics announced that its investigational therapy obecabatagene autoleucel (obe-cel) has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. FDA. Obe-cel is a CD19-targeted CAR-T therapy currently being evaluated in a phase 2 clinical trial named FELIX for the treatment of relapsed/refractory adult B-cell acute lymphoblastic leukemia. (WuXi AppTec)

Reducing the Risk of Death by 20% in Patients with Biliary Tract Cancer: Key PD-L1 Inhibitor Combination Granted FDA Priority Review

Today, AstraZeneca announced that the FDA has granted priority review status to the supplemental Biologics License Application (sBLA) for the anti-PD-L1 antibody durvalumab (trade name: Imfinzi). It is intended for use in combination with standard chemotherapy to treat patients with locally advanced or metastatic biliary tract cancer (BTC). The FDA is expected to respond in the third quarter of this year. (WuXi AppTec)

Editas Gene Therapy Receives FDA Designation Again for Treating Beta Thalassemia

Recently, Editas Medicine announced that the U.S. FDA has granted EDIT-301 Rare Pediatric Disease Designation. EDIT-301 is an investigational gene-editing medicine for the treatment of beta-thalassemia. (WuXi AppTec)

Kelon's First Inhalant Agent to Be Approved Soon

Recently, Hunan Kelun Pharmaceutical's replica of the fourth class of ipratropium bromide solution for inhalation has entered the administrative approval stage. If approved smoothly, it will become the first inhaled agent approved for marketing by Kelun Pharmaceutical. Ipratropium bromide is a highly selective M receptor blocker with a strong relaxing effect on bronchial smooth muscle, suitable for the maintenance treatment of bronchospasm caused by chronic obstructive pulmonary diseases, including chronic bronchitis and emphysema, etc. (MiNe Network)

Bayer's Nubeqa New Indication Application Accepted by U.S. FDA

Recently, Bayer announced that the U.S. FDA has accepted a supplemental new drug application for Nubeqa (darolutamide), a prostate cancer medication, for use in combination with chemotherapy to treat patients with metastatic hormone-sensitive prostate cancer (mHSPC). (Sina Medicine News)

CDE Accepts Marketing Application for Qilu Aflibercept Intravitreal Injection Solution

Recently, Qilu Pharmaceutical's marketing application for Aflibercept Ophthalmic Injection, submitted as a Class 3.3 new drug, has been accepted by the CDE, making it the first Aflibercept biosimilar to be reported for production in China. Aflibercept, developed by Bayer/Regeneron, is a VEGF inhibitor that inhibits angiogenesis and reduces vascular permeability by blocking signaling pathways mediated by VEGF-A, VEGF-B, and placental growth factor (PLGF). (MENET)

Hansoh Pharma Submits New Indication Application for "Pegmocept" to Market

On the 5th, the CDE official website showed that the listing application for Hansoh Pharmaceutical's Pemodex Injection (formerly known as: Pegylated Hematide) was accepted. Based on the progress of clinical trials, it is speculated that the new indication applied for this time is anemia in non-dialysis patients with chronic kidney disease. (CDE)

Two-Week Oral Therapy for Rapid Relief of Depression Symptoms Submits New Drug Application

Recently, Sage Therapeutics and Biogen jointly announced the initiation of a rolling submission of a New Drug Application (NDA) for zuranolone, intended for the treatment of major depressive disorder (MDD). Zuranolone is an oral therapy developed for treating MDD and postpartum depression (PPD). The two companies have already submitted the non-clinical portion of the NDA and anticipate submitting the remaining sections for the MDD indication in the second half of 2022. (WuXi AppTec)

Increased Thrombosis Risk: Pfizer Pauses a Hemophilia Gene Therapy Clinical Trial

Latest news shows that although the U.S. FDA lifted the hold on the Phase III Affine clinical study of the hemophilia A gene therapy giroctocogene fitelparvovec in March this year, Pfizer and its partner Sangamo Therapeutics voluntarily suspended the development trial and began adjusting the treatment plan after discovering that the therapy might increase the risk of thrombosis. (Sina Medicine News)

Extending Life of Patients with Advanced Breast Cancer by Nearly 16 Months: Novartis' CDK4/6 Inhibitor Shows Positive Long-term Clinical Results

Today, Novartis announced that its CDK4/6 inhibitor Kisqali (ribociclib), in combination with fulvestrant as a first-line therapy, extended the overall survival of postmenopausal HR+/HER2- advanced or metastatic breast cancer patients by nearly 16 months compared to fulvestrant alone in a Phase 3 clinical trial. The press release noted that Kisqali is the first CDK4/6 inhibitor-fulvestrant combination to demonstrate overall survival benefits in this first-line treatment setting. (WuXi AppTec)

ZF Bio's COVID-19 Recombinant Protein Vaccine Phase III Results Published with 75.7% Efficacy

On the 4th, the New England Journal of Medicine (NEJM) published efficacy and safety data on the recombinant novel coronavirus protein vaccine (CHO cell) (ZF2001, trade name: Zikeweide) developed by Anhui Zhifei Longcom Biopharmaceutical Co., Ltd. (Zhifei Biologics) for the prevention of COVID-19 infection in adults. Between December 12, 2020, and December 15, 2021, a total of 28,873 participants received at least one dose of ZF2001 or placebo and were included in the safety analysis. In the latest analysis, 158 cases in the ZF2001 group of 12,625 participants and 580 cases in the placebo group of 12,568 participants reported primary endpoint events, with a vaccine efficacy of 75.7% (95% confidence interval [CI], 71.0-79.8). (Medicube)

Positive 3-Year Efficacy of Roche's Oral Innovative Therapy for Severe SMA Patients

Recently, Roche announced the latest three-year clinical trial results of its oral therapy Evrysdi (risdiplam) for treating patients with Type 1 Spinal Muscular Atrophy (SMA). The trial results showed that an estimated 91% of Type 1 SMA patients treated with Evrysdi were still alive after three years of treatment and continued to improve or maintain motor function. (WuXi AppTec)

FDA Clears Oral Microbiome Therapy for Phase 3 Clinical Trial Restart

Recently, Finch Therapeutics announced that the U.S. FDA has allowed the continuation of clinical trials for its leading oral microbiome therapy, CP101, aimed at preventing recurrent Clostridioides difficile infections. (WuXi AppTec)

Positive Phase 2 Clinical Results for Oral Delivery of Biologics and Innovative Cytokine Therapy

Recently, Applied Molecular Transport (AMT) announced positive topline results from a Phase 2 clinical trial evaluating its investigational oral IL-10 cytokine therapy, AMT-101, as a monotherapy for the treatment of chronic pouchitis. Based on the review of safety and efficacy data, the independent Data Monitoring Committee (DMC) recommended advancing AMT-101 to Phase 3 clinical trials at a dose of 3 mg for the treatment of chronic pouchitis. (WuXi AppTec)

New Generation PDE4 Inhibitor Submitted for Clinical Trial in China by Innovent Biologics

Today, the CDE official website announced that UNION therapeutics and Innovent Biologics jointly submitted six clinical trial applications for orismilast extended-release tablets, which have been accepted. Public information shows that orismilast is a next-generation PDE4 inhibitor developed by UNION, which has been granted Fast Track designation by the U.S. FDA. In 2021, Innovent Biologics obtained exclusive rights to the candidate drug in China (including mainland China, Hong Kong, Macao, and Taiwan regions) through a collaboration worth over $260 million. (CDE)

Ultrasound Promotes Fracture Healing: FDA Approves New Medical Device for Market

Recently, Orthofix Medical announced that the U.S. FDA has approved the company's AccelStim system, a medical device developed to stimulate bone healing, for market release. This medical device offers a safe and effective non-surgical treatment option for newly occurred or unhealed fractures. It emits low-intensity pulsed ultrasound signals to stimulate the natural bone healing process and promote fracture recovery. (WuXi AppTec)

*Disclaimer: This article was written by an author who has settled in Sina Medicine News. The views expressed represent the personal opinions of the author and do not reflect the position of Sina Medicine News.