YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 236 drug applications between 6 November 2021 and 12 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 40, covering 32 drug names.
2021/11/06 – 2021/11/12
- New acceptances this week
- 236
- Drugs with new generic filings (by drug name, de-duplicated)
- 32
- 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
236filings, 40 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 123 |
| New drug | 47 |
| Generic | 40 |
| Import | 16 |
| Unspecified | 6 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 160 |
| Therapeutic biologic | 46 |
| TCM | 27 |
| Prophylactic biologic | 2 |
| 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
32 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 | 泊沙康唑注射液 · No verified English name | 2 | 2 | 1 |
| 3 | Tacrolimus Capsules | 2 | 1 | 2 |
| 4 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 2 | 1 | 2 |
| 5 | Terbutaline Sulfate Injection | 2 | 1 | 2 |
| 6 | Sugammadex Sodium Injection | 2 | 1 | 6 |
| 7 | Ranolazine Prolonged-Release Tablets | 2 | 1 | 3 |
| 8 | Sodium Valproate Oral Solution | 1 | 1 | 1 |
| 9 | Lidocaine and Prilocaine Cream | 1 | 1 | 24 |
| 10 | Carbetocin Injection | 1 | 1 | 6 |
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
152 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangxi Ge Hong Tang Fang Lve Pharmaceutical Co., Ltd. romanized | 8 | 7 | 0 |
| 2 | Hunan Wei Er Qiang Pharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 3 | Hunan De Kang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Hangzhou Minsheng Pharmaceutical Co., Ltd | 5 | 3 | 2 |
| 5 | Guangdong Da Zhong Pharmaceutical Co., Ltd. romanized | 5 | 2 | 0 |
| 6 | Zhejiang Zan Sheng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Bristol-Myers Squibb Company | 4 | 3 | 0 |
| 8 | Novartis Europharm Limited | 4 | 2 | 0 |
| 9 | Eli Lilly Nederland B.V. | 4 | 1 | 0 |
| 10 | Takeda Manufacturing Austria AG | 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
73 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2021/11/12New drug · Class 1 | 注射用IAE0972 · No verified English nameCXSL2101415 | Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized |
| 2021/11/12New drug · Class 2.2 | 艾司奥美拉唑镁碳酸氢钠胶囊 · No verified English nameCXHS2101051 | Xiamen En Cheng Pharmaceutical Co., Ltd. romanized |
| 2021/11/12New drug · Class 1 | HLX208片 · No verified English nameCXHL2101654 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
| 2021/11/12New drug · Class 1 | WXSH0057片 · No verified English nameCXHL2101653 | Zhejiang Long Chuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/12New drug · Class 1 | WXSH0057片 · No verified English nameCXHL2101652 | Zhejiang Long Chuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/12New drug · Class 2.2 | 布立西坦缓释片 · No verified English nameCXHL2101651 | Shanghai Bo Zhi Yan Xin Drug Technology Co., Ltd. romanized |
| 2021/11/12New drug · Class 1 | BPI-371153胶囊 · No verified English nameCXHL2101650 | Bei Da Pharma Co., Ltd. romanized |
| 2021/11/12New drug · Class 1 | BPI-371153胶囊 · No verified English nameCXHL2101649 | Bei Da Pharma Co., Ltd. romanized |
| 2021/11/12New drug · Class 1 | HS-10382片 · No verified English nameCXHL2101648 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/12New drug · Class 1 | HS-10382片 · No verified English nameCXHL2101647 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/12New drug · Class 1 | HS-10382片 · No verified English nameCXHL2101646 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/11Import · Class 1 | SAR444245注射液 · No verified English nameJXSL2101126 | Sanofi-aventis recherche & développement; Sanofi (China) Investment Co. Ltd. |
| 2021/11/11Import · Class 1 | Gepotidacin片 · No verified English nameJXHL2101241 | GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. Limited |
| 2021/11/11Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2102009 | Topfond Pharmaceutical Co., Ltd. |
| 2021/11/11Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2102006 | Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2021/11/11Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2102005 | Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2021/11/11New drug · Class 1.1 | 白热斯丸 · No verified English nameCXZL2101032 | Xinjiang Wei Wu Er Zi Zhi Qu Wei Wu Er Pharmaceuticals Research Institute romanized |
| 2021/11/11New drug · Class 1 | GR1803注射液 · No verified English nameCXSL2101420 | Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized; Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/11New drug · Class 1 | STI-6129注射液 · No verified English nameCXSL2101419 | Zhejiang Ai Sen Pharma Co., Ltd. romanized |
| 2021/11/11New drug · Class 1 | AK112注射液 · No verified English nameCXSL2101417 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/11/11New drug · Class 1 | CS0159片 · No verified English nameCXHL2101645 | Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/11New drug · Class 1 | CS0159片 · No verified English nameCXHL2101644 | Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/11New drug · Class 1 | CS0159片 · No verified English nameCXHL2101643 | Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/11New drug · Class 1 | OB756片 · No verified English nameCXHL2101642 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized |
| 2021/11/11New drug · Class 1 | KL340399注射液 · No verified English nameCXHL2101635 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2021/11/11New drug · Class 1 | KL340399注射液 · No verified English nameCXHL2101634 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
43 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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