E-Weekly Pharma News: Second-Largest U.S. Biopharma IPO, I-Mab Splits and Drops 10%, WuXi AppTec Steps In to Stabilize Market, Lilly’s Diabetes Drug Surges 970%, and Year’s Biggest M&A Deal Unveiled
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In the last week before the festival, the National Medical Products Administration released the "2023 Drug Evaluation Report," while the National Healthcare Security Administration explored new regulations for the initial pricing of newly listed drugs, both sending out positive signals.
Eli Lilly, AstraZeneca, and other MNCs release earnings reports; a new TOP10 MNC revenue landscape has emerged. In terms of performance in China, Merck & Co. has risen to the top. Additionally, several "blockbuster" drugs exceeded expectations, such as Eli Lilly's tirzepatide (a 970% surge in its hypoglycemic version) and Vertex’s triple combination therapy for cystic fibrosis… During the same period, Roche's next-generation C5 inhibitor was launched in China as a “world-first,” marking a significant milestone.
The largest multi-billion-dollar M&A deal since the beginning of the year has been completed, with Novo Nordisk "acquiring" CDMO giant Catalent. In addition, Novartis has acquired the German company MorphoSys.
In the capital market, the "First Self-Immune CAR-T Stock" successfully landed on NASDAQ; another CXO company terminated its STAR Market IPO; Wuxi AppTec implemented share buybacks and issued statements for consecutive "market rescues"; Tianjing Biotechnology (Shanghai) Co., Ltd. spun off its China assets to operate independently, while Zang Jingwu will step down from his board position.
Let's take a look at what major events happened in the last week of 2023?
Policy Dynamics
China's National Healthcare Security Administration Explores New Rules for Initial Pricing of Newly Listed Drugs
On February 5, the National Healthcare Security Administration's "Notice on Establishing a Price Formation Mechanism for Newly Listed Chemical Drugs to Encourage High-Quality Innovation" draft was circulated for comments through relevant industry associations. The main objective is to adhere to the principle that drug prices are determined by the market while enhancing the role of the government, improving the overall efficiency of new drug listings, and supporting high-quality innovative drugs in achieving "rewards corresponding to high investment and high risk." This not only opens the door to free pricing for innovative drugs but also provides more detailed management for the entire lifecycle pricing mechanism of both innovative and generic drugs.
"2023 Annual Drug Evaluation Report" Released
Recently, the National Medical Products Administration released the "2023 Annual Drug Evaluation Report".
In 2023, the Center for Drug Evaluation under the National Medical Products Administration accepted 2,997 new drug clinical trial applications, representing a year-on-year increase of 33.56%; 170 validation clinical trial applications, marking a 32.81% increase from 2022; and 470 new drug marketing authorization applications, reflecting a 40.72% rise compared to the previous year. Throughout 2023, China approved 40 Class 1 innovative drugs for marketing, among which 9 were approved through the priority review and approval process, 13 were granted conditional marketing approval, and 8 were included in the breakthrough therapy designation program during the clinical research phase.
"Special Provisions for the Management of Traditional Chinese Medicine Standards" Open for Public Comment
On February 5, the National Medical Products Administration (NMPA) publicly solicited opinions on the "Management of Traditional Chinese Medicine Standards (Draft for Comments)" that it had drafted. The document clearly outlines the main principles of TCM standard work, such as adhering to the inheritance of TCM theory and traditional experience, maintaining scientific, rigorous, practical, and standardized approaches, linking with clinical safety and efficacy, and upholding overall quality control. At the same time, the document emphasizes that the research and formulation of TCM standards should follow TCM theory, respect traditional experiential identification, and reflect the characteristics of TCM.
"Optimization of the Pilot Work Plan for the Reform of the Review and Approval Process for Drug Supplemental Applications" Announced
On February 7, the National Medical Products Administration issued the "Notice on Printing and Distributing the Pilot Work Plan for Reforming and Optimizing the Review and Approval Process for Drug Supplemental Applications." The main objectives include optimizing the review and approval process for drug supplemental applications, with provincial drug regulatory authorities providing upfront services for post-marketing change research, significantly reducing the technical review time required for supplemental applications involving inspections. The content includes providing upfront guidance, inspection, testing, and dossier preparation services for major changes within their jurisdiction based on the principles of "early intervention, tailored strategies for each enterprise, full-process guidance, and integration of research and review."
Large pharmaceutical
AstraZeneca Invests $300 Million to Build Cell Therapy Factory
Recently, AstraZeneca revealed a $300 million investment to build a facility in Rockville, Maryland, USA, for the production of cell therapy products critical for pivotal clinical trials and commercial supply.
In the past two years, AstraZeneca has made a high-profile push into the cell therapy field, carrying out several medium and small-sized acquisitions and BD deals in this area. In 2023, AstraZeneca reached strategic partnerships with Quell Therapeutics and Cellectis respectively, and capped off the year by acquiring Gracell Biotechnologies, a China-based pharmaceutical company, for over $1 billion.
Roche's Next-Generation C5 Inhibitor Approved for Marketing in China, as "World's First"
On February 7, the official website of the China National Medical Products Administration showed that Roche's Crovalimab Injection has been officially approved for marketing. It is used for adult and adolescent (≥12 years old) patients with paroxysmal nocturnal hemoglobinuria who have not received complement inhibitor treatment.
Covalemonab is a humanized complement inhibitor C5 monoclonal antibody. This product was developed simultaneously worldwide and was first approved for marketing in China.
Paroxysmal nocturnal hemoglobinuria (PNH) is a chronic intravascular hemolysis caused by acquired hematopoietic stem cell gene mutations leading to blood cell membrane defects, and has been included in the first batch of China's rare disease directory.
Vertex Single Product Sales Reach $9 Billion
Recently, Vertex's 2023 financial report revealed that its cystic fibrosis (CF) product — the triple combination therapy Trikafta/Kaftrio — generated annual sales of $8.94 billion, accounting for approximately 90% of total revenue. With no competitors for Trikafta/Kaftrio and high profit margins, its trend toward becoming the next blockbuster drug is increasingly evident.
Starting with the rare disease cystic fibrosis product assets, Vertex has been focusing heavily on this field, paying attention to the iterative upgrading of cystic fibrosis products. Almost all of its several acquisitions and BD moves are aimed at enhancing the technical strength in this field.
Gilead Terminates All CD47 Antibody Hematological Tumor Clinical Programs
On February 7, Gilead announced that it had terminated the Phase III ENHANCE-3 study of CD47 monoclonal antibody Magrolimab for the treatment of acute myeloid leukemia (AML). The U.S. FDA has placed all Magrolimab studies for myelodysplastic syndromes (MDS) and AML on full hold. The main reason is that the latest data found no therapeutic effect of "Magrolimab + Azacitidine + Venetoclax" and observed an increased risk of death, primarily caused by infections and respiratory failure.
Hengrui's Oral Small Molecule GLP-1 Receptor Agonist Approved for Phase II Clinical Trial
On February 6, Hengrui Medicine announced that HRS-7535 Tablets, a Class 1 new drug independently developed by its subsidiary Shengdi Medicine, had been approved by the National Medical Products Administration to conduct Phase II clinical trials for weight loss indications.
HRS-7535 is a novel oral small-molecule GLP-1 receptor agonist that can not only activate the human GLP-1 receptor, promote insulin secretion from the pancreas, reduce glucagon secretion, and inhibit gastric emptying, but also enhance satiety and suppress appetite by influencing the central nervous system, directly reducing energy intake through mechanisms used for treating type 2 diabetes mellitus (T2DM) and weight loss.
Luye Pharma Collaborates with Korean Pharma Company Myung-In Pharmaceutical
On February 5, Luye Pharma announced that it had signed a cooperation agreement with Korea Myungin Pharm to grant the latter the commercial rights in Korea for its exclusive new drug—Rivastigmine Transdermal Patch, administered twice a week, used for treating symptoms of mild to moderate Alzheimer's disease.
Compared with similar products on the market, Luye Pharma's Rivalif has a lower usage frequency, which can improve patient medication adherence; compared with oral formulations, Rivalif is absorbed by the body through skin penetration, offering convenient administration for patients with swallowing difficulties.
CSPC Mingfule Approved for Acute Ischemic Stroke Indication
On February 5, CSPC Pharmaceutical Group announced on the Hong Kong Stock Exchange that the new indication for thrombolytic treatment of acute ischemic stroke patients using Mingfule (rhTNK-tPA), developed by its subsidiary CSPC Mingfule Pharmaceuticals Co., Ltd., has been approved for marketing by the National Medical Products Administration.
CSPC Group introduced that this indication is the first of its kind to be approved in China, and it is also the second indication for Mingfule to be approved in China after the acute myocardial infarction indication. It is reported that this product is a third-generation thrombolytic drug, which can complete a single bolus intravenous injection within 5-10 seconds.
RMB 2 Billion: Huadong Medicine Plans to Invest in Building a Biologics Innovation and Manufacturing Center
On February 7, Huadong Medicine announced that the company's board of directors agreed that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong, would invest in the construction of a bio-innovation manufacturing center project based on its development plans and new product launch schedules. The total investment for the project is expected to be 2 billion yuan, to be implemented in phases, with the first phase investment amounting to approximately 1.188 billion yuan.
The main purposes of investment and construction are: to meet the industrial development needs in the biopharmaceutical field, further reduce operating costs; and strengthen the construction of a global innovative R&D ecosystem and technology platform.
Biotechnology
Innovent Biologics' GLP-1R/GCGR Dual Agonist Masitopeptide Submitted for Market Approval
Recently, Innovent Biologics announced that the first new drug application for its GLP-1R/GCGR dual agonist, Masmidotide, has been accepted by the CDE for long-term weight control in adult patients with obesity or overweight.
In addition to promoting insulin secretion, lowering blood sugar, and reducing weight by activating GLP-1R, MASHIDU peptide can also enhance weight loss efficacy by increasing energy expenditure through the activation of GCGR, while improving liver fat metabolism. If successfully launched, MASHIDU peptide will become the first domestically produced weight-loss innovative drug in China targeting both GCGR and GLP-1R, as well as the GLP-1R/GCGR dual agonist with the fastest global clinical research progress.
CFO of Innovent Biologics Hands Over the Baton
On February 5, Innovent Biologics announced that Hao Xi had retired from his position as Chief Financial Officer (CFO), and Fei You has taken over as the CFO of Innovent Biologics Group. Meanwhile, in the announcement, Innovent Biologics mentioned that although Hao Xi stepped down from the CFO role, he will continue to serve on the board as an executive director, meaning he will not leave Innovent but will continue to participate in the board’s strategic and business decision-making. According to Innovent's official website, during his tenure, Hao Xi was responsible for group finance, investor relations, funds, channels, and information technology management.
BeiGene's Zanubrutinib Approved for Five Indications in Thailand
On February 7, BeiGene announced that zanubrutinib had been approved for five indications in Thailand, for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, adult patients with Waldenström's macroglobulinemia (WM), adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 therapy, adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and in combination with obinutuzumab for adult patients with follicular lymphoma (FL) who have undergone at least two prior lines of therapy.
DualityBio's Next-Gen ADC Granted FDA Fast Track Designation
On February 6, DualityBio and BioNTech announced that the U.S. FDA has granted Fast Track designation to their TROP2 ADC product DB-1305/BNT325 for the treatment of patients with platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have previously received 1-3 systemic treatment regimens. DB-1305/BNT325 was initially developed by DualityBio. In August 2023, DualityBio and BioNTech expanded their collaboration to jointly advance the development, manufacturing, and commercialization of the product.
Data from Phase I/II clinical trials indicate that this product demonstrates promising anti-tumor activity in patients with TROP2-expressing solid tumors who have failed standard treatments and received multiple prior lines of therapy.
Asieris Pharmaceuticals Terminates Further Development of APL-1202 in Combination with Chemotherapy Instillation for Relevant Indications
On the evening of February 4, Yaponc Pharmaceuticals announced that the pivotal clinical trial for its product APL1202, used in combination with chemotherapy instillation for treating recurrent high-risk non-muscle invasive bladder cancer (NMIBC) after chemotherapy instillation failure, has been completed. Statistical analysis results showed that although certain efficacy trends were observed in some patient populations, the study did not meet its primary endpoint. The company has decided to terminate further development of APL-1202 in combination with chemotherapy instillation for this indication.
Berry Genomics "Sells Land to Survive"
On the evening of February 4, Berry Genomics announced that its wholly-owned subsidiary, Fujian Berry Genomics Co., Ltd., holds a plot of land located in the Binhai New City, Changle District, Fuzhou City, with a land use area of 99,573 square meters. Fujian Berry has constructed the "Fujian Berry Genomics Digital Life Science Park" project on this plot, which includes Phase I South Area (completed and registered for property ownership), Phase I North Area (under construction), and Phase II Central Plot (not yet started).
Capital Market
$16.5 Billion: Novo Nordisk Acquires Catalent
On February 5, Novo Holdings announced that it would acquire Catalent for $16.5 billion, marking the largest deal in the company's history. Novo Holdings is a holding and investment company responsible for managing the assets of the Novo Nordisk Foundation.
After the deal was announced, Catalent's shares rose about 10% in pre-market trading on Monday.
As part of the transaction, Novo Nordisk will acquire three production facilities of Catalent located in Italy, Belgium, and the United States from Novo Holding for a payment of 11 billion US dollars.
$2.9 Billion: Novartis Acquires MorphoSys
On February 5, Novartis reached an all-cash acquisition agreement with German biopharmaceutical company MorphoSys for a purchase price of 2.7 billion euros, approximately 2.9 billion US dollars. This acquisition will further expand Novartis' oncology portfolio and strengthen its global presence in hematology. Upon completion of the acquisition, Novartis will own pelabresib (CPI-0610), a BET inhibitor used in combination with ruxolitinib to treat patients with myelofibrosis (MF).
Affected by this news, MorphoSys's stock price surged over 40% on Monday.
Jazz Pharmaceuticals Acquires KRAS Inhibitor for $870 Million
On February 7, Jazz Pharmaceuticals announced that it had reached an agreement with Redx Pharma to acquire Redx's KRAS inhibitor program, including a KRAS G12D-specific inhibitor and a pan-KRAS inhibitor. Redx will receive a $10 million upfront payment and is eligible for up to $870 million in development, regulatory, and commercial milestone payments.
Redx is a clinical-stage biotechnology company focused on the discovery and development of novel small-molecule targeted drugs for the treatment of fibrotic diseases, cancer, and cancer-related fibrosis.
Tianjing Biotechnology Divests China Assets
On February 7, I-Mab announced a major strategic adjustment: its China subsidiary has reached an agreement with I-Mab Biopharma Hangzhou to divest its assets and operations in China to the latter.
According to the final agreement, I-Mab will transfer 100% of the issued shares of its wholly-owned subsidiary, I-Mab Biopharma Co., Ltd., which operates the company's business in China, to I-Mab Hangzhou in a cash-free and debt-free manner, with a total consideration not exceeding the equivalent of US$80 million in RMB. Upon completion of the transaction, I-Mab Hangzhou will acquire multiple pharmaceutical assets from I-Mab in China and assume all future development costs associated with these assets.
As of the closing on February 8, Tianjing Biotechnology (Shanghai) Co., Ltd. plummeted 10%.
WuXi AppTec Completes 1 Billion Yuan Repurchase in Record Time
On the evening of February 5, WuXi AppTec announced that the company had implemented the first share repurchase through centralized bidding. The number of shares repurchased was 20.2754 million, accounting for 0.69% of the company's total share capital as of the announcement date. The average repurchase price was RMB 49.321 per share, with a total fund usage of RMB 1 billion (excluding transaction fees). The repurchase plan was announced on February 2.
WuXi AppTec stated that the repurchased shares will be temporarily held in the company's dedicated share repurchase account and will be cancelled in accordance with relevant regulations and the repurchase plan. Subsequently, the company will fulfill the relevant cancellation, capital reduction procedures, and information disclosure obligations in accordance with the law.
Akeso Biopharma Acquires 35% Equity of KangRong Eastern
On February 9, Akeso Biopharma announced that its subsidiary, Zhongshan Akeso Biopharmaceuticals Co., Ltd., has signed an agreement with Dongrui Biologics Investment Development (Asia) Co., Ltd., a subsidiary of Dongrui Pharmaceuticals. Zhongshan Akeso will acquire a 35% stake in Kangrong Eastern (Guangdong) Pharmaceutical Co., Ltd. held by Dongrui Biologics for approximately RMB 267 million. Upon completion of this transaction, Kangrong Eastern will become a wholly-owned subsidiary of Zhongshan Akeso.
The core assets of Kangrong East include Inucisumab, a Class I new drug in the review and approval stage for new drug marketing, and Prolucisumab, a Class I new drug currently in Phase II clinical trials.
Cell Therapy Company Kyverna Goes Public on Nasdaq, Surges 36%
On February 8, cell therapy company Kyverna Therapeutics went public on the US stock market at an offering price of $22 per share, issuing 14.5 million shares and raising a total of $319 million. On the day of the IPO, Kyverna's market value was $1.225 billion based on the closing price. This offering is the second-largest IPO in the US biotechnology sector this year, only behind CG Oncology.
Kyverna is one of the first biotechnology companies to utilize CAR-T therapy for treating autoimmune diseases. Its pipeline includes both autologous and allogeneic next-generation CAR-T therapies, which can be used for B cell-mediated autoimmune diseases. The most advanced pipeline is currently in Phase I/II clinical trials.
CRO Company澎立生物Terminates Sci-Tech Innovation Board IPO
On February 5, the official website of the Shanghai Stock Exchange showed that Pengli Biomedical Technology (Shanghai) Co., Ltd. voluntarily withdrew its application documents for listing on the STAR Market, and its IPO was terminated.
PharmAb is one of the earliest CRO companies in China to focus on preclinical efficacy research and evaluation for innovative drug development, mainly providing CRO services for the development of various innovative drugs worldwide. Among the completed CRO projects for drug development, innovative drugs account for over 90%.
It is reported that Sequoia Hengchen directly holds 7.72% of the shares in澎立生物. Gaoling Chenjun is its 7th largest shareholder, with a shareholding ratio of 4.05%.
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