YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 230 drug applications between 10 November 2021 and 16 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 40, covering 27 drug names.
2021/11/10 – 2021/11/16
- New acceptances this week
- 230
- Drugs with new generic filings (by drug name, de-duplicated)
- 27
- 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
230filings, 40 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 117 |
| New drug | 44 |
| Generic | 40 |
| Import re-registration | 14 |
| Import | 9 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 167 |
| Therapeutic biologic | 32 |
| TCM | 26 |
| Biologic | 3 |
| 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
27 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dexmedetomidine Hydrochloride Injection | 3 | 2 | 0 |
| 2 | Sodium Valproate Concentrated Solution for Injection | 2 | 1 | 0 |
| 3 | Tacrolimus Capsules | 2 | 1 | 2 |
| 4 | Ozagrel Sodium Injection | 2 | 1 | 3 |
| 5 | Obeticholic Acid Tablets | 2 | 1 | 0 |
| 6 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 7 | Bisoprolol Fumarate Tablets | 2 | 1 | 6 |
| 8 | Pregabalin Capsules | 2 | 1 | 12 |
| 9 | Cytarabine for Injection | 2 | 1 | 2 |
| 10 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 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
140 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangxi Ge Hong Tang Fang Lve Pharmaceutical Co., Ltd. romanized | 9 | 8 | 0 |
| 2 | Hunan Wei Er Qiang Pharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 3 | Upjohn Manufacturing Ireland Unlimited | 6 | 1 | 0 |
| 4 | Da Lian Tian Shan Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized | 4 | 2 | 0 |
| 6 | Fujian Sheng Fu Kang Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | Sanofi-aventis groupe | 4 | 1 | 0 |
| 8 | Takeda Manufacturing Austria AG | 4 | 1 | 0 |
| 9 | Upjohn US 2 LLC | 4 | 1 | 0 |
| 10 | Hainan Wei Kang Pharmaceutical (Qian Shan) 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
66 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/11/16Import · Class 2.2 | 奥妥珠单抗注射液 · No verified English nameJXSL2101130 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2021/11/16Generic · Class 3 | Ozagrel Sodium InjectionCYHS2102031 | Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2021/11/16Generic · Class 3 | Ozagrel Sodium InjectionCYHS2102030 | Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2021/11/16Generic · Class 3 | Pentoxifylline InjectionCYHS2102029 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2021/11/16Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2102025 | Ji Chuan Pharma Group Co., Ltd. romanized |
| 2021/11/16Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2102024 | Ji Chuan Pharma Group Co., Ltd. romanized |
| 2021/11/16Generic · Class 3 | Obeticholic Acid TabletsCYHL2101040 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized |
| 2021/11/16Generic · Class 3 | Obeticholic Acid TabletsCYHL2101039 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized |
| 2021/11/16New drug · Class 1 | AK104注射液 · No verified English nameCXSL2101425 | Kang Fang Pharma Co., Ltd. romanized |
| 2021/11/16New drug · Class 1 | 注射用DR30303 · No verified English nameCXSL2101424 | Zhejiang Dao Er Bio Technology Co., Ltd. romanized |
| 2021/11/16New drug · Class 1 | ASK120067片 · No verified English nameCXHS2101052 | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized |
| 2021/11/16New drug · Class 1 | BIOS-0618片 · No verified English nameCXHL2101665 | Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/16New drug · Class 1 | BIOS-0618片 · No verified English nameCXHL2101664 | Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/16New drug · Class 1 | JAB-3312胶囊 · No verified English nameCXHL2101663 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2021/11/16New drug · Class 1 | JAB-3312胶囊 · No verified English nameCXHL2101662 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2021/11/16New drug · Class 1 | JAB-21822片 · No verified English nameCXHL2101661 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2021/11/16New drug · Class 1 | JAB-21822片 · No verified English nameCXHL2101660 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2021/11/16New drug · Class 1 | TSN084片 · No verified English nameCXHL2101659 | Tai Li Bio Technology (Shanghai) Co., Ltd. romanized |
| 2021/11/16New drug · Class 1 | TSN084片 · No verified English nameCXHL2101658 | Tai Li Bio Technology (Shanghai) Co., Ltd. romanized |
| 2021/11/16New drug · Class 1 | TSN084片 · No verified English nameCXHL2101657 | Tai Li Bio Technology (Shanghai) Co., Ltd. romanized |
| 2021/11/15Import · Class 1 | Ritlecitinib胶囊 · No verified English nameJXHL2101244 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2021/11/15Import · Class 1 | Ritlecitinib胶囊 · No verified English nameJXHL2101243 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2021/11/15Generic · Class 3 | Thioctic Acid InjectionCYHS2102018 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2021/11/15New drug · Class 1.1 | QA108颗粒 · No verified English nameCXZL2101033 | Zhuhai Qi Wei Bio Technology Co., Ltd. romanized |
| 2021/11/15New drug · Class 1 | WJ01075片 · No verified English nameCXHL2101656 | Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/15New drug · Class 1 | WJ01075片 · No verified English nameCXHL2101655 | Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/12Import · Class 1 | BIIB059 · No verified English nameJXSL2101127 | Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd |
| 2021/11/12New drug · Class 3.4 | 人凝血酶原复合物 · No verified English nameCXSS2101051 | Hua Lan Bio Gong Cheng Chongqing Co., Ltd. romanized |
| 2021/11/12New drug · Class 3.4 | 人凝血酶原复合物 · No verified English nameCXSS2101050 | Hua Lan Bio Gong Cheng Chongqing Co., Ltd. romanized |
| 2021/11/12New drug · Class 1 | PM8002注射液 · No verified English nameCXSL2101423 | Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized |
36 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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