YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 264 drug applications between 15 March 2023 and 21 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 46 drug names.
2023/03/15 – 2023/03/21
- New acceptances this week
- 264
- Drugs with new generic filings (by drug name, de-duplicated)
- 46
- 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
264filings, 68 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 111 |
| Generic | 68 |
| New drug | 37 |
| Import re-registration | 31 |
| Import | 9 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 197 |
| TCM | 32 |
| Therapeutic biologic | 29 |
| Biologic | 5 |
| Prophylactic biologic | 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
46 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Amiodarone Hydrochloride Injection | 4 | 2 | 0 |
| 2 | Cefalexin Granules for Oral Suspension | 3 | 1 | 0 |
| 3 | Ampicillin Sodium and Sulbactam Sodium for Injection | 3 | 1 | 13 |
| 4 | Acetylcysteine Solution For Inhalation | 2 | 2 | 4 |
| 5 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 6 | Norepinephrine Bitartrate Injection | 2 | 2 | 9 |
| 7 | Sodium Valproate Concentrated Solution for Injection | 2 | 1 | 0 |
| 8 | Tacrolimus Ointment | 2 | 1 | 6 |
| 9 | Lansoprazole Enteric Capsules | 2 | 1 | 3 |
| 10 | Rivastigmine transdermal system | 2 | 1 | 1 |
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
161 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bracco Imaging Italia S.r.L. | 24 | 1 | 0 |
| 2 | Zhu Zhou Qian Jin Pharma Co., Ltd. romanized | 6 | 5 | 0 |
| 3 | Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 5 | 4 | 0 |
| 4 | Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 5 | AstraZeneca AB | 4 | 3 | 0 |
| 6 | Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 7 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 3 | 2 | 2 |
| 8 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 3 | 2 | 0 |
| 9 | Hubei Min Kang Pharmaceutical Co., Ltd. romanized | 3 | 2 | 0 |
| 10 | Amgen Inc. | 3 | 1 | 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
67 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/03/21Import · Class 2.2 | 注射用戈沙妥珠单抗 · No verified English nameJXSL2300056 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2023/03/21Import · Class 1 | 注射用Abelacimab · No verified English nameJXSL2300055 | Anthos Therapeutics Inc.; Labcorp Pharmaceutical Research and Development (Beijing) Co. Ltd. |
| 2023/03/21Generic · Class 3 | Acetaminophen InjectionCYHS2300856 | Jilin Si Huan Pharmaceutical Co., Ltd. romanized; Jilin Si Zhang Pharmaceutical Co., Ltd. romanized |
| 2023/03/21Generic · Class 3 | Acetaminophen InjectionCYHS2300855 | Jilin Si Huan Pharmaceutical Co., Ltd. romanized; Jilin Si Zhang Pharmaceutical Co., Ltd. romanized |
| 2023/03/21Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2300854 | Topfond Pharmaceutical Co., Ltd. |
| 2023/03/21Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2300853 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/03/21Generic · Class 3 | Formoterol Fumarate Inhalation SolutionCYHS2300852 | Jiangsu Zhang Tai Pharma Co., Ltd. romanized |
| 2023/03/21Generic · Class 3 | Minoxidil Topical SolutionCYHS2300850 | Ren Xi Pharmaceuticals Technology Hebei Co., Ltd. romanized; Hua Bei Pharmaceutical Hebei Hua Nuo Co., Ltd. romanized |
| 2023/03/21New drug · Class 1.2 | Z018B胶囊 · No verified English nameCXZL2300019 | Beijing Hui Bao Yuan Bio Technology Co., Ltd. romanized |
| 2023/03/21New drug · Class 1.2 | Z018B · No verified English nameCXZL2300018 | Beijing Hui Bao Yuan Bio Technology Co., Ltd. romanized |
| 2023/03/21New drug · Class 3.3 | 地舒单抗注射液 · No verified English nameCXSS2300014 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2023/03/21New drug · Class 1 | 注射用IAP0971 · No verified English nameCXSL2300205 | Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized |
| 2023/03/21New drug · Class 1 | 人脂肪间充质干细胞注射液 · No verified English nameCXSL2300204 | Beijing Ai Ge Gan Xi Bao Technology Co., Ltd. romanized |
| 2023/03/21New drug · Class 1 | 注射用金纳单抗 · No verified English nameCXSL2300203 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2023/03/20Generic · Class 3 | Cefalexin Granules for Oral SuspensionCYHS2300841 | Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized |
| 2023/03/20Generic · Class 3 | Cefalexin Granules for Oral SuspensionCYHS2300840 | Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized |
| 2023/03/20Generic · Class 3 | Cefalexin Granules for Oral SuspensionCYHS2300839 | Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized |
| 2023/03/20Generic · Class 3 | Diprophylline InjectionCYHS2300838 | Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/03/20New drug · Class 1 | 人骨髓间充质干细胞注射液 · No verified English nameCXSL2300202 | Jiu Zhi Tang Mei Ke (Beijing) Xi Bao Technology Co., Ltd. romanized |
| 2023/03/18Generic · Class 3 | Fluoxetine Hydrochloride Oral SolutionCYHS2300837 | Changzhou Si Yao Pharmaceutical Co., Ltd. romanized |
| 2023/03/18Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2300830 | Hui Yu Kang Cheng (Zhejiang) Pharmaceuticals Technology Co., Ltd. romanized; Liaoning Yao Lian Pharmaceutical Co., Ltd. romanized |
| 2023/03/18Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2300829 | Hui Yu Kang Cheng (Zhejiang) Pharmaceuticals Technology Co., Ltd. romanized; Liaoning Yao Lian Pharmaceutical Co., Ltd. romanized |
| 2023/03/18Generic · Class 3 | Cetirizine Hydrochloride InjectionCYHS2300827 | Shenyang Da Shan Pharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2023/03/18New drug · Class 1 | SDT-T002细胞注射液 · No verified English nameCXSL2300201 | Sai De Te (Beijing) Bio Gong Cheng Co., Ltd. romanized |
| 2023/03/18New drug · Class 2.2; 2.4 | SHR8028滴眼液 · No verified English nameCXHS2300039 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/03/18New drug · Class 2.4 | Abiraterone Acetate TabletsCXHL2300322 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/03/18New drug · Class 1 | TQB3823片 · No verified English nameCXHL2300321 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/03/18New drug · Class 1 | TQB3823片 · No verified English nameCXHL2300320 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/03/18New drug · Class 2.2; 2.4 | SBK011口服溶液 · No verified English nameCXHL2300319 | Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/03/17Generic · Class 3 | Famotidine InjectionCYHS2300825 | Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized |
37 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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