YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 284 drug applications between 6 November 2022 and 12 November 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 50 drug names.
2022/11/06 – 2022/11/12
- New acceptances this week
- 284
- Drugs with new generic filings (by drug name, de-duplicated)
- 50
- 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
284filings, 74 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 147 |
| Generic | 74 |
| New drug | 38 |
| Import | 12 |
| Unspecified | 9 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 188 |
| TCM | 66 |
| Therapeutic biologic | 28 |
| Biologic | 1 |
| 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
50 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ibuprofen Injection | 5 | 3 | 8 |
| 2 | Pregabalin Capsules | 3 | 1 | 12 |
| 3 | Tranexamic Acid Injection | 3 | 1 | 11 |
| 4 | Bromhexine Hydrochloride Oral Solution | 2 | 2 | 22 |
| 5 | Moxifloxacin Hydrochloride Eye Drops | 2 | 2 | 4 |
| 6 | Oseltamivir Phosphate For Oral Suspension | 2 | 2 | 2 |
| 7 | Voriconazole Tablets | 2 | 1 | 1 |
| 8 | Fesoterodine Fumarate Prolonged-Release Tablets | 2 | 1 | 0 |
| 9 | Hydrocodone Bitartrate and Ibuprofen Tablets | 2 | 1 | 0 |
| 10 | Tandospirone Citrate Tablets | 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
157 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Gansu Xin Min Hai Pharmaceutical Co., Ltd. romanized | 18 | 18 | 0 |
| 2 | Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized | 13 | 13 | 0 |
| 3 | Bo Zhou Ya Ying Pharmaceuticals Technology Co., Ltd. romanized | 10 | 9 | 0 |
| 4 | Guangxi Lian He Sheng Sheng Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Haerbin Han Bang Medical Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Jiangsu Pu Lai Pharmaceuticals Bio Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Chengdu Brilliant Pharmaceutical Co., Ltd. | 4 | 2 | 1 |
| 8 | Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | IBSA Institut Biochimique SA | 4 | 1 | 0 |
| 10 | Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized | 4 | 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
69 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/11/12Import · Class 1 | Remternetug注射液(静脉注射) · No verified English nameJXSL2200200 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/11/12Import · Class 1 | Remternetug注射液 · No verified English nameJXSL2200199 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/11/12Import · Class 1 | 注射用Oregovomab · No verified English nameJXSL2200198 | OncoQuest Pharmaceuticals Inc.; IQVIA RDS (Shanghai) Co. Ltd. |
| 2022/11/12Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2201970 | Shanghai Bao Long Bio Technology Co., Ltd. romanized; Shanghai Mei You Pharmaceutical Co., Ltd. romanized |
| 2022/11/12Generic · Class 3 | Ibuprofen InjectionCYHS2201969 | Shandong Luo Xin Pharma Group Co., Ltd. romanized |
| 2022/11/12Generic · Class 3 | 镥[177Lu]氧奥曲肽注射液 · No verified English nameCYHL2200102 | Tianjin Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/11/12New drug · Class 1 | SM3321注射液 · No verified English nameCXSL2200572 | Beijing Shuo Xing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/11/12New drug · Class 1 | NMM肿瘤治疗性DNA疫苗裸质粒注射液 · No verified English nameCXSL2200571 | Gu An Ding Tai Hai Gui Bio Technology Co., Ltd. romanized |
| 2022/11/12New drug · Class 1 | 注射用IMM01 · No verified English nameCXSL2200570 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2022/11/12New drug · Class 1 | 莫非赛定利托那韦片 · No verified English nameCXHL2200893 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2022/11/12New drug · Class 1 | 注射用贺普拉肽 · No verified English nameCXHL2200892 | Shanghai He Pu Pharma Co., Ltd. romanized |
| 2022/11/12New drug · Class 2.2 | HECB1701001缓释片 · No verified English nameCXHL2200891 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2022/11/12New drug · Class 2.2 | HECB1701001缓释片 · No verified English nameCXHL2200890 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2022/11/11Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2201959 | Hainan Si Da Pharmaceutical Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized |
| 2022/11/11Generic · Class 3 | 钠钾镁钙葡萄糖注射液 · No verified English nameCYHS2201956 | Yi Chang Ren Fu Pharma Co., Ltd. romanized; Yi Chang San Xia Pharmaceutical Co., Ltd. romanized |
| 2022/11/11Generic · Class 3 | Hydrocodone Bitartrate and Ibuprofen TabletsCYHS2201954 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2022/11/11Generic · Class 3 | Hydrocodone Bitartrate and Ibuprofen TabletsCYHS2201953 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2022/11/11Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2201947 | Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized |
| 2022/11/11Generic · Class 3 | 盐酸非索非那定干混悬剂 · No verified English nameCYHS2201943 | Ji Chuan Pharma Group Co., Ltd. romanized |
| 2022/11/11Generic · Class 3 | 盐酸非索非那定干混悬剂 · No verified English nameCYHS2201942 | Ji Chuan Pharma Group Co., Ltd. romanized |
| 2022/11/11New drug · Class 1.1 | 风叶咳喘平口服液 · No verified English nameCXZS2200014 | Zhuo He Pharma Group Co., Ltd. romanized; Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized |
| 2022/11/11New drug · Class 1.1 | 止得咳颗粒 · No verified English nameCXZL2200049 | Guangxi Zhong Pharmaceuticals University Fu Shu Rui Kang Hospital romanized; Guangxi Zhong Pharmaceuticals University romanized |
| 2022/11/11New drug · Class 1 | GC001溶瘤痘苗病毒注射液 · No verified English nameCXSL2200569 | Hangzhou Gong Chu Bio Technology Co., Ltd. romanized |
| 2022/11/10Generic · Class 3 | Nicorandil for InjectionCYHS2201940 | Ke Bei Yuan (Beijing) Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2022/11/10Generic · Class 3 | Nicorandil for InjectionCYHS2201939 | Ke Bei Yuan (Beijing) Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2022/11/10Generic · Class 3 | Compound Dextran 40 InjectionCYHS2201937 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/11/10Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2201933 | Zhejiang Huan Ling Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2022/11/10Generic · Class 3 | Fesoterodine Fumarate Prolonged-Release TabletsCYHS2201932 | Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized |
| 2022/11/10Generic · Class 3 | Fesoterodine Fumarate Prolonged-Release TabletsCYHS2201931 | Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized |
| 2022/11/10New drug · Class 1 | IBR854细胞注射液 · No verified English nameCXSL2200568 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
39 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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