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The Week in Review: TCMs, Clinical Trials and Approvals
publication date: Aug 22, 2009
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author/source: Richard Daverman, PhD
The common theme in China biotech news last week moved to products, with a particular emphasis on stories about trials and approvals, and an even more specific focus on traditional Chinese Medicine drugs.
The FDA granted a permit to begin a Phase II trial of a TCM, Fuzheng Huayu capsules, in patients with hepatitis C who have developed fibrosis of the liver (see story). The trial will be conducted by researchers at the University of California at San Diego. Fuzheng Huayu could become the first TCM to win approval from the FDA, if all goes well. Fuzheng Huayu was developed by the Shanghai University of Traditional Chinese Medicine. It has been used in China since 2002, where it is produced by the Shanghai Sundise Chinese Medicine Technology Development Co.
Another TCM proved its efficacy against rheumatoid arthritis in a clinical study, as reported in the most recent edition of the journal Annals of Internal Medicine (see story). The remedy, known popularly (and most colorfully) as thunder god vine or lei gong teng, is derived from the medicinal plant Tripterygium wilfordii Hook F (TwHF). In a clinical study, TwHF was compared with a sulfa drug. TwHF was almost twice as effective at decreasing joint swelling and pain as the sulfa drug.
For the first time, US Pharmacopeia has verified the quality of a traditional Chinese medicine product. The nonprofit, standards-setting organization has granted its “USP Verified” mark to ONCO-Z Coriolus Versicolor Extract, a mushroom-derived product that is produced by Hong Kong manufacturer PuraPharm International (see story). The TCM is used in China to fight cancer.
Outside the TCM world, China Pharma Holdings (OTCBB: CPHI) was given SFDA approval for Omeprazole Sodium injection, a proton pump inhibitor that is prescribed for gastroesophageal reflux disease (GERD) and other conditions caused by excessive stomach acid (see story). The drug is a generic form of Losec and Prilosec, marketed by AstraZeneca (NYSE: AZN). Although most Omeprazole products are oral, China Pharma’s formulation is an injection, which enters the blood circulation more quickly and avoids degradation in the stomach.
On the medical device front, Avita Medical, an Australian medical device company, received SFDA approval for its ReCell Autologous Spray-On Skin, a one-use kit that harvests a patient’s skin cells and then reapplies them in a spray (see story). ReCell kits are used for both to aid wound healing and for cosmetic purposes. Helicon Group, which oversaw the China approval process for Avita, will distribute ReCell through an established network of partners that specialize in medical devices.
Sinovac Biotech (NYSE Amex: SVA) (北京科兴生物制品有限公司) reported that its swine flu (H1N1) vaccine was effective after a single dose (see story). The seropositive rate, seroconvertive rate and GMT increasing multiple reached the international criteria for vaccines. The top-line results were unblinded in Beijing this week, allowing Sinovac to claim bragging rights as the first vaccine manufacturer in the world to complete a successful test of a swine flu vaccine.
As the high season for earnings reports continues, China Sky One Medical (NSDQ: CSKI) (中国天字一号医药公司) reported record high results for Q2 of 2009, and the company reiterated its guidance for full-year 2009 (see story). During the second quarter, revenue climbed 36% to $32.2 million, while net income rose 17% to $9.5 million. China Sky One said it remains on track to achieve its 2009 goals of $128-130 million of revenue, a 40% increase, and net income of $38-39 million.
Sinovac Biotech (NYSE Amex: SVA) (北京科兴生物制品有限公司) also announced good results for its Q2, thanks largely to a single $12.8 million order for its major product, the hepatitis A vaccine Healive® (see story). Sinovac said Q2 revenues were up 21% at $20 million while net income increased a much larger 74% to $5.8 million. According to Sinovac, 89% of the $12.8 million order was filled during Q2. That means $11.4 million of the company’s $20 million in Q2 revenues derived from the one-time event. The company expects a similarly large set of orders for its swine flu vaccine to maintain the high momentum.
Disclosure: none.
The FDA granted a permit to begin a Phase II trial of a TCM, Fuzheng Huayu capsules, in patients with hepatitis C who have developed fibrosis of the liver (see story). The trial will be conducted by researchers at the University of California at San Diego. Fuzheng Huayu could become the first TCM to win approval from the FDA, if all goes well. Fuzheng Huayu was developed by the Shanghai University of Traditional Chinese Medicine. It has been used in China since 2002, where it is produced by the Shanghai Sundise Chinese Medicine Technology Development Co.
Another TCM proved its efficacy against rheumatoid arthritis in a clinical study, as reported in the most recent edition of the journal Annals of Internal Medicine (see story). The remedy, known popularly (and most colorfully) as thunder god vine or lei gong teng, is derived from the medicinal plant Tripterygium wilfordii Hook F (TwHF). In a clinical study, TwHF was compared with a sulfa drug. TwHF was almost twice as effective at decreasing joint swelling and pain as the sulfa drug.
For the first time, US Pharmacopeia has verified the quality of a traditional Chinese medicine product. The nonprofit, standards-setting organization has granted its “USP Verified” mark to ONCO-Z Coriolus Versicolor Extract, a mushroom-derived product that is produced by Hong Kong manufacturer PuraPharm International (see story). The TCM is used in China to fight cancer.
Outside the TCM world, China Pharma Holdings (OTCBB: CPHI) was given SFDA approval for Omeprazole Sodium injection, a proton pump inhibitor that is prescribed for gastroesophageal reflux disease (GERD) and other conditions caused by excessive stomach acid (see story). The drug is a generic form of Losec and Prilosec, marketed by AstraZeneca (NYSE: AZN). Although most Omeprazole products are oral, China Pharma’s formulation is an injection, which enters the blood circulation more quickly and avoids degradation in the stomach.
On the medical device front, Avita Medical, an Australian medical device company, received SFDA approval for its ReCell Autologous Spray-On Skin, a one-use kit that harvests a patient’s skin cells and then reapplies them in a spray (see story). ReCell kits are used for both to aid wound healing and for cosmetic purposes. Helicon Group, which oversaw the China approval process for Avita, will distribute ReCell through an established network of partners that specialize in medical devices.
Sinovac Biotech (NYSE Amex: SVA) (北京科兴生物制品有限公司) reported that its swine flu (H1N1) vaccine was effective after a single dose (see story). The seropositive rate, seroconvertive rate and GMT increasing multiple reached the international criteria for vaccines. The top-line results were unblinded in Beijing this week, allowing Sinovac to claim bragging rights as the first vaccine manufacturer in the world to complete a successful test of a swine flu vaccine.
As the high season for earnings reports continues, China Sky One Medical (NSDQ: CSKI) (中国天字一号医药公司) reported record high results for Q2 of 2009, and the company reiterated its guidance for full-year 2009 (see story). During the second quarter, revenue climbed 36% to $32.2 million, while net income rose 17% to $9.5 million. China Sky One said it remains on track to achieve its 2009 goals of $128-130 million of revenue, a 40% increase, and net income of $38-39 million.
Sinovac Biotech (NYSE Amex: SVA) (北京科兴生物制品有限公司) also announced good results for its Q2, thanks largely to a single $12.8 million order for its major product, the hepatitis A vaccine Healive® (see story). Sinovac said Q2 revenues were up 21% at $20 million while net income increased a much larger 74% to $5.8 million. According to Sinovac, 89% of the $12.8 million order was filled during Q2. That means $11.4 million of the company’s $20 million in Q2 revenues derived from the one-time event. The company expects a similarly large set of orders for its swine flu vaccine to maintain the high momentum.
Disclosure: none.
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