Hong Kong (HSI) Biotech Industry Analysis

Date	Market Cap	Revenue	Earnings	PE
Thu, 20 Jan 2022	HK$381.4b	HK$31.1b	-HK$31,891,209,285.00	13.2x
Sat, 18 Dec 2021	HK$431.5b	HK$31.1b	-HK$31,849,546,921.00	13.5x
Mon, 15 Nov 2021	HK$489.1b	HK$31.0b	-HK$31,744,501,684.00	14.4x
Wed, 13 Oct 2021	HK$493.9b	HK$30.5b	-HK$31,492,826,100.00	14.6x
Fri, 10 Sep 2021	HK$528.3b	HK$30.4b	-HK$31,412,511,864.39	17.6x
Sun, 08 Aug 2021	HK$541.3b	HK$30.2b	-HK$32,058,827,347.35	13.6x
Sat, 01 May 2021	HK$572.9b	HK$27.8b	-HK$26,637,487,691.09	16.9x
Tue, 02 Feb 2021	HK$532.5b	HK$24.0b	-HK$26,645,675,939.75	66.8x
Fri, 06 Nov 2020	HK$321.9b	HK$20.1b	-HK$11,752,667,554.40	42.7x
Mon, 10 Aug 2020	HK$372.4b	HK$17.2b	-HK$11,180,934,453.59	56.1x
Sun, 03 May 2020	HK$234.2b	HK$16.9b	-HK$10,102,316,008.15	29.1x
Wed, 05 Feb 2020	HK$176.6b	HK$17.1b	-HK$7,752,252,997.18	40.7x
Sat, 09 Nov 2019	HK$164.7b	HK$16.0b	-HK$8,602,972,653.41	21.7x
Fri, 02 Aug 2019	HK$126.2b	HK$15.5b	-HK$8,892,457,780.72	16.8x
Mon, 06 May 2019	HK$130.4b	HK$14.9b	-HK$8,334,412,400.45	18.3x
Thu, 07 Feb 2019	HK$94.6b	HK$14.1b	-HK$6,309,891,852.07	14.2x


Biotech	-0.83%

Company	Last Price	7D	1Y	Valuation
1877 Shanghai Junshi Biosciences	HK$57.60	24.5% +HK$10.3b	-25.2%	PS13x
1672 Ascletis Pharma	HK$6.82	69.2% +HK$3.0b	120.0%	PS152.2x
9966 Alphamab Oncology	HK$13.24	3.4% +HK$412.3m	-12.6%	PS238.4x
2616 CStone Pharmaceuticals	HK$7.80	4.7% +HK$407.6m	-26.4%	PS6.6x
1167 Jacobio Pharmaceuticals Group	HK$12.52	3.3% +HK$308.6m	-40.2%	PS14.5x

Jan 13

Alphamab Oncology announces Enrollment Completed in Phase II Clinical Study of KN026 Combined with KN046

Alphamab Oncology announced that the phase II clinical study of KN026 (HER2 bispecific antibody) combined with KN046 (PD-L1/CTLA-4 bispecific antibody) (KN026-203) has successfully completed the enrollment of all patients in China, and the interim analysis is expected in the second quarter of 2022. KN026-203 is an open-label, phase II, multi-center clinical study to evaluate the efficacy and safety of KN026 combined with KN046 in the treatment of HER2-positive solid tumors. Enrollment of all 102 patients, including HER2-positive GC/GEJ, breast cancer and other HER2-positive solid tumors, has been completed at 25 study centers nationwide. The preliminary results from KN026-203 is reported in patients with HER2-positive metastatic breast cancer (MBC) as poster at SABCS 2021, female patients with HER2-positive MBC who were previously treated with at least one HER2-targeted combination therapy were enrolled, the ORR was 48.5% (16/33, 95% CI: 30.8-66.5), and 1 patient achieved CR; the DCR was 78.8% (26/33, 95% CI: 61.1-91.0). Data from a Phase Ib study (KN046-IST-02) of KN026 plus KN046 for GI with HER2 positive/mutation/low-expression are presented as Poster at the ESMO congress 2021. In 27 HER2-positive patients, the ORR was 51.9% with median DOR 11.2 months; Among those 27 patients 21 were GC/GEJ, the ORR was 71.4% for treatment naïve patients (n=7), 42.9% for 14 patients who had been exposed to systemic therapy and 40.0% for 10 patients who had received trastuzumab. With more patient enrolled, similar trend for efficacy and safety has been observed. KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. KN026 has demonstrated potentially equivalent efficacy compared with Trastuzumab and Pertuzumab in combination, and was superior to either single agent, such as increased binding affinity, as well as better tumor inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines. KN026 received IND approval from the National Medical Products Administration (NMPA) of China and U.S. Food and Drug Administration (FDA) in 2018. Currently, it is in multiple phase I/II clinical trials in China and phase I clinical trial in the United States. The results of Phase I clinical trials show KN026 has good safety, tolerance and potentially superior anti-tumor activity in HER2-positive breast cancer patients who progressed after multiple lines of anti-HER2 treatment. KN046 is PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a novel mechanism - CTLA-4 fused with PD-L1 single domain antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg (suppress tumor immunity) clearing function. There are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, thymic cancer, pancreatic cancer, HCC, ESCC and TNBC in Australia, the US and China. The results of these clinical trials have shown an advantage in survival for patients. Alphamab Oncology has received FDA clearance to enter phase II trial of KN046 based on the clinical results in China and Australia. Moreover, KN046 has obtained the U.S.FDA's orphan drug designation for thymic epithelial tumor in September 2020. Four pivotal clinical trials are currently being conducted.

Jan 12

CARsgen Therapeutics Holdings Limited Announces United States Food and Drug Administration Grants Regenerative Medicine Advanced Therapy Designation to CT041

CARsgen Therapeutics Holdings Limited announced that the United States Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to CT041 for the treatment of patients who have advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) with Claudin18.2-positive tumor. CT041 is the first CAR T-cell product candidate against solid tumor with RMAT designation. With the RMAT designation, CT041 enjoys all the benefits of Fast Track and Breakthrough Therapy designations including early and intensive FDA guidance on efficient product candidate development and eligibility for rolling review and priority review. Products granted RMAT designation may also be eligible for accelerated approval. In October 2019, CARsgen's CT053 CAR T-cell product candidate was first granted RMAT designation by the FDA for the treatment of relapsed and/or refractory multiple myeloma. CT041 is CARsgen's second product candidate with RMAT designation. CT041 is an autologous CAR T-cell product candidate developed by CARsgen. CT041 targets the treatment of CLDN18.2-positive solid tumors with a primary focus on GC/GEJ and pancreatic cancer (PC). CT041 has demonstrated promising therapeutic efficacy and favorable safety in ongoing clinical trials. CT041 has the potential to become a backbone therapy for GC/GEJ and PC and benefit a large population of patients worldwide. According to the results of the investigator-initiated trial of CT041 that was orally presented at the European Society of Medical Oncology Congress 2021 (ESMO 2021), 18 patients with GC/GEJ who failed at least two prior lines of therapy (including 8 [44%] patients exposed to an anti-PD-1 or PD-L1 antibody) at the dose of 2.5×108 CAR T cells achieved an objective response rate (ORR) of 61.1%. Historical data shows that for patients with GC/GEJ who fail at least two prior lines of therapy, the efficacy rate of chemotherapy is about 4% to 8%, and the efficacy rate of anti-PD-1 antibody is about 11%. Therefore, compared with other treatments for patients with GC/GEJ who fail at least two prior lines of therapy, CT041 shows a significant improvement in ORR. In addition to the investigator-initiated trials in China, CARsgen has initiated a Phase Ib/II clinical trial for advanced GC/GEJ and PC in China and a Phase 1b clinical trial for advanced gastric or pancreatic adenocarcinoma in North America. CARsgen also intends to conduct a pivotal Phase 2 clinical trial in North America in 2022. In 2020 and 2021, CT041 received Orphan Drug designation from the FDA for the treatment of GC/GEJ and Orphan Medicinal Product designation from the European Medicines Agency (EMA) for the treatment of advanced gastric cancer. In November 2021, CT041 was granted Priority Medicines (PRIME) eligibility by the EMA for the treatment of advanced gastric cancer.

Hong Kong (HSI) Biotech Industry Analysis

Industry Valuation and Performance

Industry Trends

Top Stock Gainers and Losers

Latest News

2616

EQRx, Inc. and CStone Pharmaceuticals Announce Sugemalimab Demonstrates Statistically Significant Overall Survival Benefit in Patients with Stage IV Non-Small Cell Lung Cancer

9926

Akeso's AK117 to Initiate a Phase Ib/II Clinical Trial with or without Chemotherapy for the Treatment of Advanced Malignant Tumors

9969

InnoCare Pharma and Keymed Biosciences Jointly Announce Dosing of First Patient in Clinical Trial of CD20xCD3 Bispecific Antibody CM355

1167

Jacobio Pharmaceuticals Group Co., Ltd. Announces Investigational New Drug Approval of Aurora A Inhibitor JAB-2485 from Food and Drug Administration of the United States

1672

Ascletis Pharma Inc. Announces U.S. Ind Approval of Asc22, A Subcutaneously Administered Pd-L1 Antibody for Functional Cure of Chronic Hepatitis B

9966

Alphamab Oncology announces Enrollment Completed in Phase II Clinical Study of KN026 Combined with KN046

1952

Everest Medicines Will Participate in Clinical Trial with Gilead and Msd to Evaluate Trodelvy® in Combination with Keytruda® (Pembrolizumab) in First-Line Metastatic Non-Small Cell Lung Cancer

2171

CARsgen Therapeutics Holdings Limited Announces United States Food and Drug Administration Grants Regenerative Medicine Advanced Therapy Designation to CT041

9995

RemeGen Co., Ltd. Announces National Medical Products Administration (Nmpa) Grants Conditional Marketing Approval for Disitamab Vedotin for the Treatment of HER2 Expressing Locally Advanced or Metastatic Urothelial Carcinoma

1877

Shanghai Junshi Biosciences Co., Ltd. Receives the Acceptance Notice for the Investigational New Drug Application

2137

Brii Biosciences Limited Doses First Patient in Phase 2a/2b Clinical Trial of BrII-179 (VBI-2601) for the Functional Cure of Chronic Hepatitis B

1801

Innovent Biologics, Inc. Announces NMPA of China Acceptance of Supplemental New Drug Application for TYVYT® (Sintilimab Injection Plus Bevacizumab Biosimilar Injection and Chemotherapy in Patients with EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer Who Progressed after EGFR-TKI Therapy

1530

We Think 3SBio (HKG:1530) Can Manage Its Debt With Ease

2256

Key Executive recently bought HK$1.1m worth of stock

775

Does CK Life Sciences Int'l. (Holdings) (HKG:775) Have A Healthy Balance Sheet?

1061

Upcoming dividend of HK$0.04 per share