Review of This Week's Hot Topics

After Receiving 1.5 Billion Yuan in Collaboration Funds, Hua Medicine Terminates Cooperation Agreement with Bayer

On November 22, Huadong Medicine, a Hong Kong Stock Exchange 18A listed company, announced that it had issued a written notice to Bayer Corporation, expressing its intention, starting from January 1, 2025, to take over the development of its product used for...Hua Tang Ning, the First-in-Class Glucokinase Activator for the Treatment of Type 2 DiabetesCommercialization Responsibilities in ChinaRecalled by Hualing Pharmaceuticals, which has the right and plans toStarting from January 1, 2025Termination Agreement.

To support the continued commercial sales of Huatangning in China,Hua Medicine May Seek Other Potential Partners, for the commercialization of Huatangning in China.

It is reported that Hua Ling Pharmaceuticals and BayerAugust 17, 2020Sign a Strategic Cooperation Agreement on Huatangning (Dorzagliatin Tablets, dorzagliatin).

As of now,Hua Medicine Receives Bayer's Milestone Payment Totaling 1.5 Billion RMBThis funding will be used to build its own sales team and expand overseas operations, further enhancing Huami Medicine's competitiveness in the global diabetes treatment field. Previously, Huami Medicine's cooperation model with Bayer was a 50-50 split, and the funds obtained were sufficient to cover the cost of building its own sales team, bringing additional profits to the company.

Johnson & Johnson China Reported to Cut 20% of Workforce

Recently, Johnson & Johnson China again announced layoffs.Johnson & Johnson China Implements Layoffs Across Multiple Product LinesThe compensation plans vary, including "N+1", "N+2", and "N+3".The scale of this layoff is 20%., mainly involvingSurgical Department。

Some of the laid-off employees stated that the layoff notices were sent privately via email. Although Johnson & Johnson has been carrying out staff optimization in recent years, this round of layoffs involves a relatively wide range of structural adjustments and has far-reaching impacts. Some employees mentioned that the compensation package was relatively good, based on years of service, with the maximum reaching N+3.

Johnson & Johnson China's layoffs this time are part of a global layoff plan. Since 2023,Johnson & Johnson has undergone multiple layoffs, involving business mergers, department closures, and factory staff reductions.. Especially after the contraction of pharmaceutical businesses in the cardiovascular and metabolic departments, layoffs have become more frequent. Nevertheless, Johnson & Johnson has not responded to this in public reports.

Johnson & Johnson Released Q3 Financial Report on October 15Sales increased by 5.2% year-on-year, reaching 22.471 billion US dollars., butNet profit fell 37.5% year-on-year to just US$2.694 billionUnder Non-GAAP (Non-U.S. Generally Accepted Accounting Principles), the adjusted net profit decreased by 13.3% year-on-year.

MSD Optimizes China Diabetes Business with Layoffs

Market sources said that,MSD China's Diabetes Business Undergoes Layoffs Amid Drug Procurement。

A reporter has confirmed the authenticity of the news from an insider at Merck.The extent of layoffs is not yet clear.。

Merck has three diabetes drugs, respectivelySitagliptin, Sitagliptin Metformin, ErtugliflozinThe first two drugs are the main sales sources for the company's diabetes business.

Among them, Merck's Sitagliptin was the world's first DPP-4 inhibitor to be marketed, having been approved for sale in the United States as early as 2006. It entered the Chinese market for sales in 2009. In its early years, due to the lack of competitors for a long period, Sitagliptin’s sales performance in the global market was quite remarkable, with sales revenue gradually increasing.

But from Merck's global revenue perspective, these years, constrained by the patent cliff and fierce market competition, the sales of Sitagliptin and Sitagliptin Metformin have somewhat shrunk.

In 2022, the combined sales of Sitagliptin and Sitagliptin Metformin reached 4.513 billion US dollars.In 2023, the combined sales of these two drugs have decreased to $3.366 billion.

Changes in Pfizer's Chief Scientific Officer and R&D President; Commercialization Collaboration with Zai Lab

November 20,Pfizer Announces Appointment of Chris Boshoff, M.D., Ph.D., as Chief Scientific Officer and President of R&D, effective from January 1, 2025.

Dr. Boshoff, formerly the head of Pfizer Oncology and Executive Vice President, will succeed Dr. Mikael Dolsten, who announced his departure from Pfizer earlier this year. Upon taking office next year, Boshoff will continue as a member of Pfizer's executive leadership team and will oversee R&D functions across all therapeutic areas.

Pfizer's oncology R&D team will maintain its fully integrated structure, with Dr. Roger Dansey serving as the interim Chief Oncology Officer, reporting to Dr. Boshoff starting January 1, 2025. Prior to his retirement, Dr. Dansey will assist Dr. Boshoff in selecting a new Chief Oncology Officer.

On November 21, Pfizer and Zai Lab announced,The two parties have reached a strategic cooperation in mainland China regarding the new antibacterial drug Dynabax® (sulbactam sodium-durlobactam sodium)., exclusively handled by a subsidiary of Pfizer for the product inCommercial Operations in Mainland ChinaThrough this collaboration, Zai Lab will leverage the industry-leading commercialization capabilities of Pfizer's subsidiary in the anti-infective field to help patients in need in China access this important therapy more quickly.

Novartis Raises Mid-term Sales Forecast

On November 21, Novartis Pharmaceuticals stated,By 2029, the company's revenue will grow at an annual rate of 6%., higher than the previous expectation of 5%. NovartisUp-regulationFor its subsidiary drugsPeak Sales Expectations for Cosentyx, Kisqali, Kesimpta, Pluvicto, and Leqvio。

First HER2 Bispecific Antibody Approved by FDA, BeiGene Holds APAC Rights

On November 20 local time, Jazz Pharmaceuticals announced that the U.S. FDA had granted accelerated approval to itsHER2-Targeted Bispecific Antibody Zanidatamab (Ziihera) Launched, for the treatment of previously treated, unresectable, locally advanced or metastatic HER2-positiveBiliary Tract CancerPatient. The drug was co-developed by Jazz Pharmaceuticals and Zymeworks. The press release noted that this isThe First and Only HER2 Bispecific Antibody for HER2+ Biliary Tract Cancer Approved by the FDA。

As early asIn 2018, BeiGene secured exclusive rights in Asia (excluding Japan), Australia, and New Zealand for it and another bispecific ADC through a $430 million collaboration.

Currently,China NMPAZenidatamab has been accepted.Marketing Application for Second-Line Treatment of HER2+ Biliary Tract Cancer(CXSS2400056), and it has been included in the priority review, with predictions suggesting approval is likely inThe Second Quarter of Next YearApproved.

Zanidatamab (ZW25) is a bispecific antibody based on Zymeworks' Azymetric platform, capable of simultaneously binding to two non-overlapping HER2 epitopes, known as dual complementary binding. This unique design enables multiple mechanisms of action, including dual blockade of HER2 signaling, enhanced binding and removal of HER2 protein from the cell surface, and robust antibody effector functions to enhance anti-tumor activity in patients. Previously, zanidatamab has been granted Breakthrough Therapy Designation, Fast Track Designation, Priority Review, and Orphan Drug Designation by the FDA, as well as Breakthrough Therapy Designation and Priority Review by the NMPA.

The World's First GLP-1RA Weekly Formulation for Long-Term Weight Management, Wegovy®, Launched in China

On November 17, Novo Nordisk announced today,The world's first and currently onlyFor Long-term Weight ManagementGlucagon-like Peptide-1 Receptor Agonist (GLP-1RA) Weekly FormulationNovo Nordisk officially launched in China.

NovoGain® (Semaglutide Injection for Long-term Weight Management) is able to achieveAn average weight loss of approximately 17%。

The main component of NovoGain is semaglutide, which has a 94% homology with human GLP-1, and is also known as the "weight-loss version" of semaglutide. Novo NordiskJune this yearAnnounce that the National Medical Products Administration has approved Novo Nordisk's Wegovy (semaglutide injection for long-term weight management) for marketing in China. Previously, its semaglutide injection for glycemic control was approved in China in 2021.

Immunotech Completes Rights Issue, Raising HKD 2.34 Billion

On November 21, Hong Kong Stock Exchange 18A company Immune-Onc Therapeutics announced a significant share placement plan before trading hours and signed a placement agreement with the placement agent. Immune-Onc Therapeutics has agreed to appoint the placement agent as its exclusive placement agent forHK$7.05 per placement shareat the placement price, to be issued to subscribersA total of 33.15 million new H shares。

According to the placement agreement, the issuance of 33.15 million new H shares accounts for Yimeng MingkeApproximately 8.14% of the enlarged issued share capitalThe offering price per share of HKD 7.05 is lower than the last trading day.Discount of approximately 16.27% to the closing price, demonstrating Yiming Angke's sincerity and determination in attracting investors. The total amount raised from the placement is approximately HKD 2.34 billion,The net amount is approximately HKD 230 million.

This fundApproximately 30% of the fundsWill be used in ChinaIMM2510 Combined with Chemotherapy as First-Line TreatmentNon-Small Cell Lung Cancer (NSCLC) and Triple-Negative Breast Cancer (TNBC) as well asIb/II Phase for the Treatment of Other Solid TumorsAnd further clinical research.

SimilarlyApproximately 30% of the fundsWill be used in ChinaIMM2510 Combined with IMM27M for the Treatment of Advanced Solid TumorsPhase Ib and further clinical studies.

About10% of the fundsWill be used in ChinaIMM01 (Tidapacip) in Combination with Azacitidineand the pivotal clinical study of IMM01 (Tidapacept) in combination with Tislelizumab.

The remaining approximately 30% of the funds will be used to replenish Imeck's working capital and for general corporate purposes.

Laikang Medicine Plans to Raise HK$230 Million through Share Placement

On November 21, Laikang Medicine announced that it had entered into a placement agreement with the exclusive placement agent.HK$13.36 per shareat the price to not less than six allottees17,636,000 placement sharesThe offer price per share represents a discount of approximately 15.01% compared to the closing price of HK$15.72 per share on November 20. The number of shares offered is equivalent to the expanded total after issuance.Approximately 4.33% of the issued share capital。

Assuming full placement, the proceeds to Laekna TherapeuticsApproximately HKD 230 million, expected to be fully utilized by December 31, 2026, forAccelerate the R&D of LAE102 (ActRIIA Monoclonal Antibody)And other drug assets targeting the ActRII receptor.

The day before, Laekang announced that it had signed a clinical cooperation agreement with Eli Lilly and Company to support and accelerate the global clinical development of LAE102 for the treatment of obesity. Lilly will be responsible for conducting a Phase I study in the United States and covering the associated costs. Meanwhile, Laekang Pharmaceuticals will retain global rights to LAE102. Following this news,Laekna's stock price surged 48.3%, closing at HK$15.72 per share, with a total market value of HK$6.132 billion.

$1.1 Billion Acquisition Deal: Novartis Expands into Gene Therapy!

On November 21, Novartis announced thatTotal Amount of $1.1 BillionAcquisition of Kate Therapeutics, a preclinical-stage biotechnology company, aims to significantly strengthen its strategic layout in the fields of gene therapy and neuroscience innovation. According to the agreement, Kate Therapeutics is eligible to receive up to $1.1 billion in payments, including an upfront payment upon the completion of the transaction and additional payments upon achieving specific milestones.

Kate Therapeutics' R&D pipeline includes preclinical candidates targeting Duchenne Muscular Dystrophy (DMD), Facioscapulohumeral Muscular Dystrophy (FSHD), and Type I Myotonic Dystrophy (DM1). Through its innovative gene therapy technology, Kate Therapeutics offers new therapeutic possibilities for addressing complex hereditary neuromuscular diseases that are currently challenging to treat with existing technologies.

Novartis CEO Vas Narasimhan and CFO Harry Kirsch stated,Novartis' future M&A deals may remain below $3 billion, and will seek additional M&A opportunities within its key areas (including cardiovascular, immunology, neuroscience, and oncology). The acquisition of Kate Therapeutics is part of Novartis' ongoing strategic adjustment over the years, aiming to enhance its innovation capabilities in gene therapy and neuroscience through M&A.

Joining Hands with MSD, AstraZeneca, and China National Pharmaceutical, Limin Pharmaceuticals Sells 28 Billion in Two Years

Junshi Biosciences Introduces Two Dual-Target Fusion Proteins for 750 Million; Two More Innovative Pharmaceutical Companies Expand Overseas...

On the evening of November 19, Junshi Biosciences announced that it will newly introduceRights to Two Dual-Target Fusion Proteins in Greater China, but due to the involvement of commercially sensitive information and trade secrets, Junshi Biosciences has not disclosed more details about the transaction counterpart or specific product information at this time.

November 18,Orange Sails PharmaceuticalsAnnounced a global strategic collaboration agreement with Avenzo Therapeutics, Inc. Under the agreement, Orange Sail Pharmaceuticals will grant AvenzoDevelopment, production, and commercialization globally (excluding Greater China)Nectin4/TROP2 Bispecific Antibody Conjugate，While retaining the relevant rights in Greater China.

Connie 600 Million USD Re-Export

Highlights:

18A Innovative Drug Companies "Selling Shells": A New Path for Biotech Transformation?

The 10th Batch of National Collection Initiated! Scale Exceeds 40.7 Billion, Including Multiple Blockbuster Products

Nearly 8 Billion in Four Years! Akeso Biopharma Secures Another Major Round of Financing

The World's First Oral Formulation! Targeting the Billion-Dollar Gastric Cancer Market