YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 381 drug applications between 10 December 2021 and 16 December 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 43, covering 33 drug names.
2021/12/10 – 2021/12/16
- New acceptances this week
- 381
- Drugs with new generic filings (by drug name, de-duplicated)
- 33
- 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
381filings, 43 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 254 |
| New drug | 58 |
| Generic | 43 |
| Import re-registration | 11 |
| Import | 10 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 273 |
| TCM | 61 |
| Therapeutic biologic | 42 |
| Prophylactic biologic | 5 |
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
33 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Guanfacine Hydrochloride Extended Release Tablets | 4 | 1 | 4 |
| 2 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 3 | 1 | 2 |
| 3 | Ambroxol Hydrochloride Solution For Inhalation | 2 | 2 | 10 |
| 4 | Vildagliptin Tablets | 2 | 2 | 0 |
| 5 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
| 6 | Nafamostat Mesilate for Injection | 2 | 1 | 38 |
| 7 | Febuxostat Tablets | 2 | 1 | 12 |
| 8 | Clotrimazole Vaginal Tablets | 1 | 1 | 3 |
| 9 | Diquafosol Sodium Eye Drops | 1 | 1 | 5 |
| 10 | Desonide Cream | 1 | 1 | 0 |
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
166 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hua Run Shuang He Pharma Co., Ltd. romanized | 76 | 66 | 0 |
| 2 | Jilin Sheng Shen Lu Pharmaceutical Co., Ltd. romanized | 26 | 21 | 0 |
| 3 | Haerbin Tian Mei Pharma Co., Ltd. romanized | 10 | 6 | 0 |
| 4 | Zhengzhou Yu Gang Zhi Xing Pharmaceutical Co., Ltd. romanized | 8 | 7 | 0 |
| 5 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 7 | 3 | 5 |
| 6 | Guizhou Liang Ji Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Heilongjiang Kui Hua Pharma Co., Ltd. romanized | 6 | 5 | 0 |
| 8 | Janssen-Cilag International NV | 6 | 1 | 0 |
| 9 | Ha Yao Group Zhong Yao Er Factory romanized | 5 | 4 | 0 |
| 10 | Da Lian Jin Ding Chang Pharmaceuticals Technology 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
81 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/12/16Import · Class 1 | 甲磺酸氢甲硫堇(LMTM)片 · No verified English nameJXHL2101273 | TauRx Therapeutics Ltd.; dMed Biopharmaceutical Co. Ltd. |
| 2021/12/16Import · Class 1 | AZD8233注射液 · No verified English nameJXHL2101272 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2021/12/16Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2102212 | Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized |
| 2021/12/16Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2102211 | Beijing Sai Sheng Pharma Co., Ltd. romanized |
| 2021/12/16Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2102210 | Beijing Sai Sheng Pharma Co., Ltd. romanized |
| 2021/12/16Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2102204 | Jiangxi Ai Shi Te Pharmaceutical Co., Ltd. romanized |
| 2021/12/16Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2102203 | Jiangxi Ai Shi Te Pharmaceutical Co., Ltd. romanized |
| 2021/12/16Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2102202 | Jiangxi Ai Shi Te Pharmaceutical Co., Ltd. romanized |
| 2021/12/16Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2102201 | Nanjing Hua Gai Pharmaceutical Co., Ltd. romanized |
| 2021/12/16Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2102196 | Haikou Shi Pharmaceutical Factory Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2021/12/16New drug · Class 3.3 | 阿达木单抗注射液 · No verified English nameCXSS2101064 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2021/12/16New drug · Class 1.1 | 重组十五价人乳头瘤病毒疫苗(大肠埃希菌) · No verified English nameCXSL2101487 | Beijing Kang Le Wei Shi Bio Technology Co., Ltd. romanized; Liaoning Cheng Da Bio Co., Ltd. romanized |
| 2021/12/16New drug · Class 2.1 | IBI311 · No verified English nameCXSL2101482 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/12/16New drug · Class 1 | PM8002注射液 · No verified English nameCXSL2101477 | Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2021/12/16New drug · Class 1 | 注射用TFX05-01 · No verified English nameCXHL2101767 | Shenzhen Yang Li Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/16New drug · Class 1 | HE006片 · No verified English nameCXHL2101766 | Nanchang Hong Yi Pharma Co., Ltd. romanized |
| 2021/12/16New drug · Class 1 | HE006片 · No verified English nameCXHL2101765 | Nanchang Hong Yi Pharma Co., Ltd. romanized |
| 2021/12/16New drug · Class 1 | D-1553片 · No verified English nameCXHL2101764 | Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized |
| 2021/12/16New drug · Class 1 | D-1553片 · No verified English nameCXHL2101763 | Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized |
| 2021/12/16New drug · Class 1 | IN10018片 · No verified English nameCXHL2101762 | Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2021/12/16New drug · Class 1 | IN10018片 · No verified English nameCXHL2101761 | Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2021/12/16New drug · Class 1 | JYP0061片 · No verified English nameCXHL2101760 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/16New drug · Class 1 | JYP0061片 · No verified English nameCXHL2101759 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/16New drug · Class 1 | JYP0061片 · No verified English nameCXHL2101758 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/16New drug · Class 1 | BC0305胶囊 · No verified English nameCXHL2101749 | Shandong Dan Hong Pharmaceutical Co., Ltd. romanized |
| 2021/12/16New drug · Class 1 | BC0305胶囊 · No verified English nameCXHL2101748 | Shandong Dan Hong Pharmaceutical Co., Ltd. romanized |
| 2021/12/16New drug · Class 1 | AL01211胶囊 · No verified English nameCXHL2101742 | Ai Si Lin Ke (Suzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2021/12/16New drug · Class 1 | AL01211胶囊 · No verified English nameCXHL2101741 | Ai Si Lin Ke (Suzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2021/12/16New drug · Class 1 | AL01211胶囊 · No verified English nameCXHL2101740 | Ai Si Lin Ke (Suzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2021/12/16New drug · Class 1 | 注射用ATAP-M8 · No verified English nameCXHL2101734 | Beijing Ai Tai Pu Biopharmaceuticals Technology Co., Ltd. romanized |
51 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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