YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 297 drug applications between 19 December 2021 and 25 December 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 64, covering 44 drug names.
2021/12/19 – 2021/12/25
- New acceptances this week
- 297
- 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
297filings, 64 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 137 |
| Generic | 64 |
| New drug | 60 |
| Import | 18 |
| Unspecified | 10 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 204 |
| Therapeutic biologic | 63 |
| TCM | 23 |
| In vitro diagnostic reagent | 4 |
| Biologic | 2 |
| 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
44 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Febuxostat Tablets | 5 | 3 | 12 |
| 2 | Bromfenac Sodium Eye Drops | 2 | 2 | 7 |
| 3 | Sodium Valproate Concentrated Solution for Injection | 2 | 1 | 0 |
| 4 | Elagolix Tablets | 2 | 1 | 2 |
| 5 | Ozagrel Sodium Injection | 2 | 1 | 3 |
| 6 | Torsemide Injection | 2 | 1 | 1 |
| 7 | Tegafur,Gimeracil and Oteracil Potassium Capsules | 2 | 1 | 0 |
| 8 | Nicorandil for Injection | 2 | 1 | 1 |
| 9 | Gemcitabine Hydrochloride for Injection | 2 | 1 | 1 |
| 10 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
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
172 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Anhui Shuang He Pharma Co., Ltd. romanized | 12 | 3 | 0 |
| 2 | Boehringer Ingelheim International GmbH | 7 | 2 | 0 |
| 3 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 6 | 3 | 0 |
| 4 | Novo Nordisk A/S | 6 | 2 | 0 |
| 5 | Lv Shi Zi (Zhongguo) Bio Zhi Pin Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Pfizer Europe MA EEIG | 5 | 4 | 0 |
| 7 | Qilu Pharmaceutical (Hainan) Co., Ltd | 5 | 3 | 5 |
| 8 | Suzhou Hua Yi Mei Bio Technology Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Novartis Pharma Schweiz AG | 4 | 3 | 0 |
| 10 | Haerbin Tian Mei Pharma Co., Ltd. romanized | 4 | 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
103 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/12/24Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2101151 | Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd. |
| 2021/12/24Import · Class 1 | Enpatoran · No verified English nameJXHL2101287 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2021/12/24Import · Class 2.4 | Belzutifan片 · No verified English nameJXHL2101285 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D(China)Co. Ltd. |
| 2021/12/24Import · Class 1 | LOXO-305片 · No verified English nameJXHL2101284 | Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/12/24Import · Class 1 | LOXO-305片 · No verified English nameJXHL2101283 | Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/12/24Import · Class 1 | LOXO-305片 · No verified English nameJXHL2101282 | Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/12/24Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2102278 | Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized; Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized |
| 2021/12/24Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2102277 | Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized; Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized |
| 2021/12/24Generic · Class 3 | Fluorouracil InjectionCYHS2102276 | Jian Jin Pharmaceutical Co., Ltd. romanized |
| 2021/12/24Generic · Class 3 | Nicorandil for InjectionCYHS2102275 | Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized |
| 2021/12/24Generic · Class 3 | Nicorandil for InjectionCYHS2102274 | Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized |
| 2021/12/24Generic · Class 3 | Torsemide InjectionCYHS2102273 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2021/12/24Generic · Class 3 | Torsemide InjectionCYHS2102272 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2021/12/24Generic · Class 3 | Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2102271 | Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized |
| 2021/12/24New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSS2101086 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/12/24New drug · Class 2.2 | 信迪利单抗注射液 · No verified English nameCXSS2101085 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/12/24New drug · Class 1 | 注射用SHR-A1811 · No verified English nameCXSL2101508 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/12/24New drug · Class 1 | SSGJ-707注射液 · No verified English nameCXSL2101507 | Dan Sheng Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2021/12/24New drug · Class 1 | XNW14010片 · No verified English nameCXHL2101811 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/24New drug · Class 1 | XNW14010片 · No verified English nameCXHL2101810 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/24New drug · Class 1 | NP107片 · No verified English nameCXHL2101809 | Shanghai Na Wei Bio Technology Co., Ltd. romanized |
| 2021/12/24New drug · Class 1 | NP107片 · No verified English nameCXHL2101808 | Shanghai Na Wei Bio Technology Co., Ltd. romanized |
| 2021/12/23Import · Class 1 | IMG-020注射液 · No verified English nameJXSL2101150 | Affibody AB; Inmagene Biopharmaceuticals (Wuhan) Co. Ltd. |
| 2021/12/23Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2102264 | Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized |
| 2021/12/23Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2102263 | Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized |
| 2021/12/23Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2102261 | Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized |
| 2021/12/23Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2102258 | Beijing Xin Mei Tai Ke Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Tian Rui Pharma Co., Ltd. romanized |
| 2021/12/23Generic · Class 3 | 奥美拉唑碳酸氢钠胶囊(II) · No verified English nameCYHS2102257 | Beijing Bai Ao Pharma Co., Ltd. romanized |
| 2021/12/23Generic · Class 3 | Compound Sulfamethoxazole TabletsCYHS2102256 | Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized |
| 2021/12/23Generic · Class 3 | Biapenem For InjectionCYHS2102250 | Shenzhen Shi Hai Bin Pharmaceutical Co., Ltd. romanized |
73 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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