YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 282 drug applications between 13 September 2022 and 19 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 44 drug names.
2022/09/13 – 2022/09/19
- New acceptances this week
- 282
- Drugs with new generic filings (by drug name, de-duplicated)
- 44
- 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
282filings, 60 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 155 |
| Generic | 60 |
| New drug | 45 |
| Unspecified | 8 |
| Import | 8 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 208 |
| TCM | 40 |
| Therapeutic biologic | 33 |
| 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
44 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dapagliflozin And Metformin Hydrochloride Extended-Release Tablets | 5 | 1 | 0 |
| 2 | Oseltamivir Phosphate For Oral Suspension | 3 | 2 | 2 |
| 3 | 复方聚乙二醇电解质散(Ⅲ) · No verified English name | 2 | 2 | 1 |
| 4 | Nintedanib Esilate Soft Capsules | 2 | 1 | 6 |
| 5 | Indobufen Tablets | 2 | 1 | 6 |
| 6 | Tandospirone Citrate Tablets | 2 | 1 | 2 |
| 7 | Tranexamic Acid Injection | 2 | 1 | 11 |
| 8 | Teicoplanin for Injection | 2 | 1 | 6 |
| 9 | Hydrocortisone Sodium Succinate for Injection | 2 | 1 | 16 |
| 10 | Doxorubicin Hydrochloride Liposome Injection | 2 | 1 | 2 |
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
164 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangxi Jin Xing Industrial Co., Ltd. romanized | 10 | 6 | 0 |
| 2 | Shandong Kong Sheng Tang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 4 | Jiangxi Ke Rui Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 7 | Sanofi -aventis France | 5 | 1 | 0 |
| 8 | Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 5 |
| 9 | Hainan Mei Lan Shi Ke Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized | 4 | 4 | 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
85 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/09/19Import · Class 1 | OMTX705注射用浓溶液 · No verified English nameJXSL2200167 | InxMed (Hong Kong) Limited; InxMed (Nanjing) Co. Ltd |
| 2022/09/19Generic · Class 3 | Digoxin InjectionCYHS2201563 | Hebei Kun An Pharma Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized |
| 2022/09/19Generic · Class 3 | Doxorubicin Hydrochloride Liposome InjectionCYHS2201562 | Changzhou Wu He Biopharmaceuticals Co., Ltd. romanized; Wuxi Zi Shan Pharma Co., Ltd. romanized |
| 2022/09/19Generic · Class 3 | Doxorubicin Hydrochloride Liposome InjectionCYHS2201561 | Changzhou Wu He Biopharmaceuticals Co., Ltd. romanized; Wuxi Zi Shan Pharma Co., Ltd. romanized |
| 2022/09/19Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2201560 | Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2022/09/19Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2201559 | Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2022/09/19Generic · Class 3 | Minoxidil Topical SolutionCYHS2201558 | Zhejiang Ding Tai Pharma Co., Ltd. romanized |
| 2022/09/19Generic · Class 3 | Olanzapine for InjectionCYHL2200080 | Qilu Pharmaceutical Co., Ltd. |
| 2022/09/19New drug · Class 1 | UB-221 皮下注射剂 · No verified English nameCXSL2200466 | Lian Sheng Yao (Yang Zhou) Biopharmaceuticals Co., Ltd. romanized |
| 2022/09/19New drug · Class 1 | 注射用BG136 · No verified English nameCXHL2200705 | Qingdao Hai Yang Biopharmaceuticals Research Institute romanized; Zhongguo Hai Yang University romanized; Zheng Da Pharmaceutical (Qingdao) Co., Ltd. romanized |
| 2022/09/19New drug · Class 1 | 注射用BG136 · No verified English nameCXHL2200704 | Qingdao Hai Yang Biopharmaceuticals Research Institute romanized; Zhongguo Hai Yang University romanized; Zheng Da Pharmaceutical (Qingdao) Co., Ltd. romanized |
| 2022/09/19New drug · Class 1 | 注射用JK0004 · No verified English nameCXHL2200703 | Shenzhen Jia Ke Bio Technology Co., Ltd. romanized |
| 2022/09/19New drug · Class 1 | 注射用JK0004 · No verified English nameCXHL2200702 | Shenzhen Jia Ke Bio Technology Co., Ltd. romanized |
| 2022/09/19New drug · Class 1 | XTYW001胶囊 · No verified English nameCXHL2200701 | Xian Xin Tong Drug Research Co., Ltd. romanized |
| 2022/09/19New drug · Class 1 | XTYW001胶囊 · No verified English nameCXHL2200700 | Xian Xin Tong Drug Research Co., Ltd. romanized |
| 2022/09/19New drug · Class 1 | 注射用WXWH0075 · No verified English nameCXHL2200699 | Zhuo He Pharma Group Co., Ltd. romanized |
| 2022/09/19New drug · Class 1 | 注射用WXWH0075 · No verified English nameCXHL2200698 | Zhuo He Pharma Group Co., Ltd. romanized |
| 2022/09/18New drug · Class 1 | DZD9008片 · No verified English nameCXHL2200697 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2022/09/18New drug · Class 1 | DZD9008片 · No verified English nameCXHL2200696 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2022/09/17Generic · Class 3 | Indobufen TabletsCYHS2201555 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/09/17Generic · Class 3 | Indobufen TabletsCYHS2201553 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/09/17New drug · Class 3.3 | 甘精胰岛素注射液 · No verified English nameCXSS2200079 | Hefei Tian Mai Bio Technology Development Co., Ltd. romanized |
| 2022/09/17New drug · Class 1 | 靶向 CD19 非病毒 PD1 定点整合 CAR-T 细胞注射液 · No verified English nameCXSL2200465 | Shanghai Bang Yao Bio Technology Co., Ltd. romanized |
| 2022/09/17New drug · Class 1 | AP-306胶囊 · No verified English nameCXHL2200695 | Shanghai Li Bang Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/17New drug · Class 1 | AP-306胶囊 · No verified English nameCXHL2200694 | Shanghai Li Bang Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/17New drug · Class 1 | AR882胶囊 · No verified English nameCXHL2200693 | Guangzhou Rui An Bo Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/17New drug · Class 1 | AR882胶囊 · No verified English nameCXHL2200692 | Guangzhou Rui An Bo Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/17New drug · Class 1 | LNK01002胶囊 · No verified English nameCXHL2200691 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized |
| 2022/09/17New drug · Class 1 | LNK01002胶囊 · No verified English nameCXHL2200690 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized |
| 2022/09/16Import · Class 1 | DS-1062a · No verified English nameJXSL2200166 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
55 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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