YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 303 drug applications between 31 August 2022 and 6 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 46, covering 35 drug names.
2022/08/31 – 2022/09/06
- New acceptances this week
- 303
- Drugs with new generic filings (by drug name, de-duplicated)
- 35
- 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
303filings, 46 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 163 |
| Generic | 46 |
| New drug | 45 |
| Import | 25 |
| Unspecified | 16 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 216 |
| TCM | 49 |
| Therapeutic biologic | 36 |
| Prophylactic biologic | 2 |
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
35 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lidocaine Hydrochloride Injection | 3 | 1 | 6 |
| 2 | Sitagliptin Phosphate Tablets | 3 | 1 | 2 |
| 3 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
| 4 | Lornoxicam for Injection | 2 | 2 | 2 |
| 5 | Perampanel Tablets | 2 | 1 | 2 |
| 6 | Ozagrel Sodium Injection | 2 | 1 | 3 |
| 7 | Ornidazole Injection | 2 | 1 | 0 |
| 8 | Palonosetron Hydrochloride Injection | 2 | 1 | 1 |
| 9 | Dapagliflozin Tablets | 2 | 1 | 84 |
| 10 | Piracetam Injection | 1 | 1 | 9 |
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
157 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized | 23 | 21 | 0 |
| 2 | Bayer AG | 11 | 11 | 0 |
| 3 | Guo Jiu Tang Shandong E Jiao Co., Ltd. romanized | 8 | 8 | 0 |
| 4 | Guo Yao Group Gong Ye Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | AstraZeneca AB | 5 | 3 | 0 |
| 10 | Eli Lilly and Company | 5 | 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
83 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/09/06Import · Class 1 | AZD7789 · No verified English nameJXSL2200155 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/09/06Import · Class 2.4 | Inclisiran注射液 · No verified English nameJXHL2200278 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2022/09/06Import · Class 2.4 | Inclisiran注射液 · No verified English nameJXHL2200277 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2022/09/06Import · Class 1 | MK-0616胶囊 · No verified English nameJXHL2200276 | Merck Sharp & Dohme LLC; Name not romanized |
| 2022/09/06Import · Class 1 | MK-0616胶囊 · No verified English nameJXHL2200275 | Merck Sharp & Dohme LLC; Name not romanized |
| 2022/09/06Generic · Class 3 | Levofloxacin InjectionCYHS2201462 | Anhui Pioneer Pharmaceutical Co., Ltd |
| 2022/09/06Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2201460 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/09/06Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2201459 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/09/06Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2201458 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/09/06Generic · Class 3 | Technetium [99mTc] Tetrofosmin InjectionCYHS2201457 | Nanjing Jiang Yuan An Di Ke Zheng Dian Zi Research Development Co., Ltd. romanized |
| 2022/09/06New drug · Class 1 | QX004N注射液 · No verified English nameCXSL2200443 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized |
| 2022/09/06New drug · Class 1 | HMI-115 · No verified English nameCXSL2200442 | He Qi Rui Pharmaceuticals (Nanjing) Co., Ltd. romanized |
| 2022/09/06New drug · Class 1 | 注射用TQB2934 · No verified English nameCXSL2200441 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2022/09/06New drug · Class 1 | KQ-L6自体嵌合抗原受体T细胞注射液 · No verified English nameCXSL2200440 | Shanghai Ke Qi Pharma Technology Co., Ltd. romanized |
| 2022/09/06New drug · Class 1 | QL1706注射液 · No verified English nameCXSL2200439 | Qilu Pharmaceutical Co., Ltd. |
| 2022/09/06New drug · Class 1 | DC561043片 · No verified English nameCXHL2200656 | Zhongguo Ke College Shanghai Drug Research Institute romanized |
| 2022/09/06New drug · Class 1 | DC561043片 · No verified English nameCXHL2200655 | Zhongguo Ke College Shanghai Drug Research Institute romanized |
| 2022/09/06New drug · Class 1 | DC561043片 · No verified English nameCXHL2200654 | Zhongguo Ke College Shanghai Drug Research Institute romanized |
| 2022/09/06New drug · Class 1 | FZJ-003凝胶 · No verified English nameCXHL2200653 | Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized |
| 2022/09/06New drug · Class 1 | FZJ-003凝胶 · No verified English nameCXHL2200652 | Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized |
| 2022/09/06New drug · Class 1 | BEBT-607片 · No verified English nameCXHL2200651 | Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized |
| 2022/09/06New drug · Class 1 | BEBT-607片 · No verified English nameCXHL2200650 | Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized |
| 2022/09/05New drug · Class 1 | LM-101注射液 · No verified English nameCXSL2200438 | Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2022/09/05New drug · Class 1 | KP104注射液 · No verified English nameCXSL2200437 | Ke Yue Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2022/09/05New drug · Class 1 | AB-218 胶囊 · No verified English nameCXHL2200649 | Bao Yuan Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2022/09/05New drug · Class 2.2; 2.4 | TML-023软膏 · No verified English nameCXHL2200648 | Wuhan Ke Fu Xin Yao Co., Ltd. romanized |
| 2022/09/04New drug · Class 1 | AK0707胶囊 · No verified English nameCXHL2200647 | Suzhou Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/04New drug · Class 1 | AK0707胶囊 · No verified English nameCXHL2200646 | Suzhou Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/03Import · Class 2.4 | INC280 · No verified English nameJXHL2200274 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2022/09/03Import · Class 2.4 | INC280 · No verified English nameJXHL2200273 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
53 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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