YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 299 drug applications between 23 February 2023 and 1 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 59, covering 47 drug names.
2023/02/23 – 2023/03/01
- New acceptances this week
- 299
- Drugs with new generic filings (by drug name, de-duplicated)
- 47
- Accepted this week, now under review
- 1
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
299filings, 59 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 163 |
| Generic | 59 |
| New drug | 38 |
| Import | 18 |
| Import re-registration | 12 |
| Unspecified | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 213 |
| TCM | 49 |
| Therapeutic biologic | 30 |
| Prophylactic biologic | 6 |
| In vitro diagnostic reagent | 1 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
47 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ambroxol Hydrochloride Oral Solution | 3 | 2 | 46 |
| 2 | Sodium Valproate Oral Solution | 2 | 1 | 1 |
| 3 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 4 | Carbazochrome Sodium Sulfonate Injection | 2 | 1 | 1 |
| 5 | Brivaracetam Tablets | 2 | 1 | 19 |
| 6 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 7 | 生理氯化钠溶液 · No verified English name | 2 | 1 | 17 |
| 8 | Erlotinib Hydrochloride Tablets | 2 | 1 | 0 |
| 9 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 2 | 1 | 2 |
| 10 | Bromhexine Hydrochloride Oral Solution | 2 | 1 | 22 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
188 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 13 | 11 | 0 |
| 2 | Guangdong Song Xia Pharma Co., Ltd. romanized | 11 | 11 | 0 |
| 3 | Guangxi Yu Yuan Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 4 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 5 | Shaanxi Nian Qing Bao Pharmaceutical Co., Ltd. romanized | 5 | 3 | 0 |
| 6 | Name not romanized | 4 | 3 | 4 |
| 7 | Aspen Pharmacare Australia Pty Ltd | 4 | 1 | 0 |
| 8 | Beijing Jia Cheng Biopharmaceuticals Technology Kai Fa Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Merck & Co. Inc. | 3 | 3 | 0 |
| 10 | Nei Menggu Yi Li Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
79 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/03/01Generic · Class 3 | Verapamil Hydrochloride InjectionCYHS2300667 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2023/03/01Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2300666 | Name not romanized; Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/03/01Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2300665 | Name not romanized; Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/03/01Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2300663 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2023/03/01Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2300662 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2023/03/01New drug · Class 1.1 | 栀黄贴膏 · No verified English nameCXZL2300014 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized; Shanghai Tu Feng Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Zhong Pharmaceuticals University romanized |
| 2023/03/01New drug · Class 1 | 注射用SHR-2001 · No verified English nameCXSL2300163 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/03/01New drug · Class 2.2; 2.4 | BTP0717 · No verified English nameCXHL2300258 | Jiangsu Nuo He Bi Tuo Xin Yao Research and Development Co., Ltd. romanized; SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
| 2023/02/28Import · Class 2.2 | 注射用阿地白介素 · No verified English nameJXSL2300043 | CLINIGEN HEALTHCARE LIMITED |
| 2023/02/28Import · Class 1 | KM-001乳膏 · No verified English nameJXHL2300040 | Kamari Pharma Ltd; WuXi Clinical Development Services (Shanghai) Co. Ltd. |
| 2023/02/28Import · Class 1 | KM-001乳膏 · No verified English nameJXHL2300039 | Kamari Pharma Ltd; WuXi Clinical Development Services (Shanghai) Co. Ltd. |
| 2023/02/28Generic · Class 3 | Formoterol Fumarate Inhalation SolutionCYHS2300661 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/02/28Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2300656 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2023/02/28Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2300655 | Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Guizhou Ke Lun Pharma Co., Ltd. romanized |
| 2023/02/28New drug · Class 2.2 | 舒格利单抗注射液 · No verified English nameCXSS2300007 | Hui Rui Investment Co., Ltd. romanized; Wuxi Yao Ming Bio Technology Co., Ltd. romanized |
| 2023/02/28New drug · Class 1 | 聚乙二醇化重组门冬酰胺酶注射液 · No verified English nameCXSL2300162 | Chongqing Pai Jin Bio Technology Co., Ltd. romanized |
| 2023/02/28New drug · Class 1 | 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2300161 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2023/02/28New drug · Class 1 | 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2300160 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2023/02/28New drug · Class 1 | 重组人源化抗HER2双特异性抗体注射液 · No verified English nameCXSL2300159 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2023/02/27Import · Class 2.4 | 阿扎胞苷薄膜衣片 · No verified English nameJXHL2300038 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2023/02/27Import · Class 2.4 | 阿扎胞苷薄膜衣片 · No verified English nameJXHL2300037 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2023/02/27Import · Class 1 | AZD9833片 · No verified English nameJXHL2300035 | AstraZeneca AB; AstraZeneca Investment (China) Co. Limited |
| 2023/02/27Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2300654 | Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Guizhou Ke Lun Pharma Co., Ltd. romanized |
| 2023/02/27Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2300648 | Anhui Hai Si Mei Pharmaceuticals Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2023/02/27Generic · Class 3 | 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2300647 | Chongqing Mai Chuan Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Wei Ao Pharmaceutical Co., Ltd. romanized |
| 2023/02/27Generic · Class 3 | Diprophylline InjectionCYHS2300643 | Name not romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2023/02/27Generic · Class 3 | Famotidine InjectionCYHS2300642 | Name not romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2023/02/27New drug · Class 1.1 | 十一方药酒 · No verified English nameCXZL2300013 | Guangxi Zhong Pharmaceuticals University Di Yi Fu Shu Hospital (Guangxi Zhong Yi Hospital) romanized |
| 2023/02/27New drug · Class 2.2 | 苏黄止咳颗粒 · No verified English nameCXZL2300012 | Beijing Dong Fang Yun Jia Technology Development Co., Ltd. romanized |
| 2023/02/27New drug · Class 1 | SHR-1654注射液 · No verified English nameCXSL2300158 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
49 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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