YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 326 drug applications between 21 October 2021 and 27 October 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 38 drug names.
2021/10/21 – 2021/10/27
- New acceptances this week
- 326
- Drugs with new generic filings (by drug name, de-duplicated)
- 38
- Accepted this week, now under review
- 0
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
326filings, 50 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 169 |
| New drug | 59 |
| Generic | 50 |
| Import | 27 |
| Import re-registration | 14 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 217 |
| TCM | 51 |
| Therapeutic biologic | 48 |
| Prophylactic biologic | 7 |
| Biologic | 3 |
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
38 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Moxifloxacin Hydrochloride And Sodium Chloride Injection | 3 | 3 | 10 |
| 2 | Levofloxacin Eye Drops | 2 | 1 | 16 |
| 3 | Torsemide Injection | 2 | 1 | 1 |
| 4 | Pregabalin Capsules | 2 | 1 | 12 |
| 5 | Tranexamic Acid Injection | 2 | 1 | 11 |
| 6 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 7 | Lenvatinib Mesilate Capsules | 2 | 1 | 4 |
| 8 | Dopamine Hydrochloride Injection | 2 | 1 | 3 |
| 9 | Oxytocin Injection | 2 | 1 | 8 |
| 10 | 酒石酸伐尼克兰片 · No verified English name | 2 | 1 | 3 |
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
177 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Gansu Fu Ge Zang Yao Co., Ltd. romanized | 30 | 27 | 0 |
| 2 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized | 7 | 3 | 0 |
| 3 | Hainan Jiu Chang Pharmaceutical Co., Ltd. romanized | 5 | 3 | 0 |
| 4 | Sanofi-Aventis Groupe | 5 | 1 | 0 |
| 5 | Novartis Pharma Schweiz AG | 4 | 3 | 0 |
| 6 | Upjohn EESV | 4 | 3 | 0 |
| 7 | Name not romanized | 4 | 3 | 0 |
| 8 | Boehringer Ingelheim International GmbH | 4 | 2 | 0 |
| 9 | Shanghai Jia Bao Yao Yin Pharmaceuticals Technology Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Shandong An Xin Pharmaceutical Co., Ltd. romanized | 4 | 2 | 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
97 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/10/27Import · Class 1 | BI685509片 · No verified English nameJXHL2101224 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2021/10/27Import · Class 1 | BI685509片 · No verified English nameJXHL2101223 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/10/27Import · Class 1 | BI685509片 · No verified English nameJXHL2101222 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/10/27Import · Class 2.4 | Tucatinib片 · No verified English nameJXHL2101221 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/10/27Import · Class 2.4 | Tucatinib片 · No verified English nameJXHL2101220 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/10/27Generic · Class 3 | Levofloxacin InjectionCYHS2101934 | Jilin Si Huan Pharmaceutical Co., Ltd. romanized |
| 2021/10/27New drug · Class 1.1 | 和胃解毒胶囊 · No verified English nameCXZL2101031 | Changsha Xin Lin Pharmaceutical Co., Ltd. romanized |
| 2021/10/27New drug · Class 1 | 首克注利单抗注射液 · No verified English nameCXSS2101042 | Zhao Ke (Guangzhou) Zhong Liu Drug Co., Ltd. romanized; Wuxi Yao Ming Bio Technology Co., Ltd. romanized |
| 2021/10/27New drug · Class 1 | AK112注射液 · No verified English nameCXSL2101392 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/10/27New drug · Class 1 | AK117注射液 · No verified English nameCXSL2101391 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/10/27New drug · Class 2.2 | 注射用全氟丙烷人血白蛋白微球 · No verified English nameCXSL2101390 | Xiamen Li Zhuo Pharma Co., Ltd. romanized |
| 2021/10/27New drug · Class 2.4 | 泽布替尼胶囊 · No verified English nameCXHL2101615 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2021/10/27New drug · Class 1 | SYHX2001片 · No verified English nameCXHL2101614 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2021/10/27New drug · Class 1 | SYHX2001片 · No verified English nameCXHL2101613 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2021/10/27New drug · Class 1 | NIP001片 · No verified English nameCXHL2101610 | Zhongguo Pharmaceuticals Research Kai Fa Center Co., Ltd. romanized |
| 2021/10/27New drug · Class 1 | NIP001片 · No verified English nameCXHL2101609 | Zhongguo Pharmaceuticals Research Kai Fa Center Co., Ltd. romanized |
| 2021/10/26Import · Class 2.2 | Emapalumab · No verified English nameJXSL2101120 | Swedish Orphan Biovitrum AG; Sobi Pharma(Guangzhou)Co. Limited |
| 2021/10/26Import · Class 2.4 | 度维利塞胶囊 · No verified English nameJXHL2101214 | Secura Bio Inc.; CSPC ZHONGQI PHARMACEUTICAL TECHNOLOGY (SJZ) CO. LTD. |
| 2021/10/26Import · Class 2.4 | 度维利塞胶囊 · No verified English nameJXHL2101213 | Secura Bio Inc.; CSPC ZHONGQI PHARMACEUTICAL TECHNOLOGY (SJZ) CO. LTD. |
| 2021/10/26Import · Class 2.4 | 紫杉醇口服溶液 · No verified English nameJXHL2101205 | DAEHWA PHARMACEUTICAL CO. LTD; Shanghai RMX Biopharma Co. Ltd |
| 2021/10/26Import · Class 2.4 | 紫杉醇口服溶液 · No verified English nameJXHL2101204 | DAEHWA PHARMACEUTICAL CO. LTD; Shanghai RMX Biopharma Co. Ltd |
| 2021/10/26Import · Class 2.4 | 紫杉醇口服溶液 · No verified English nameJXHL2101203 | DAEHWA PHARMACEUTICAL CO. LTD; Shanghai RMX Biopharma Co. Ltd |
| 2021/10/26Generic · Class 3 | Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2101924 | Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized |
| 2021/10/26Generic · Class 3 | Oxytocin InjectionCYHS2101918 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2021/10/26Generic · Class 3 | Oxytocin InjectionCYHS2101917 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2021/10/26Generic · Class 3 | Furosemide InjectionCYHS2101908 | Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2021/10/26Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2101907 | Jiangxi Yi You Pharma Co., Ltd. romanized; Jing Cheng Hui Yao Pharma Co., Ltd. romanized |
| 2021/10/26Generic · Class 3 | Torsemide InjectionCYHS2101881 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2021/10/26Generic · Class 3 | Torsemide InjectionCYHS2101880 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2021/10/26New drug · Class 1 | 普特利单抗注射液 · No verified English nameCXSS2101041 | Le Pu Bio Technology Co., Ltd. romanized; Ding Kang (Wuhan) Biopharmaceuticals Co., Ltd. romanized |
67 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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