YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 306 drug applications between 23 September 2021 and 29 September 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 53, covering 36 drug names.
2021/09/23 – 2021/09/29
- New acceptances this week
- 306
- Drugs with new generic filings (by drug name, de-duplicated)
- 36
- 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
306filings, 53 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 158 |
| Generic | 53 |
| New drug | 48 |
| Import | 21 |
| Import re-registration | 15 |
| Unspecified | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 232 |
| Therapeutic biologic | 41 |
| TCM | 27 |
| Biologic | 4 |
| 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
36 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dopamine Hydrochloride Injection | 4 | 3 | 3 |
| 2 | Clindamycin Injection | 3 | 1 | 4 |
| 3 | Esomeprazole Magnesium for Delayed-release Oral Suspension | 3 | 1 | 4 |
| 4 | Lacosamide Oral Solution | 2 | 2 | 0 |
| 5 | Bromfenac Sodium Eye Drops | 2 | 2 | 7 |
| 6 | Linezolid and Glucose Injection | 2 | 1 | 3 |
| 7 | Ibuprofen Suspension | 2 | 1 | 14 |
| 8 | Topiroxostat Tablets | 2 | 1 | 0 |
| 9 | Torsemide Injection | 2 | 1 | 1 |
| 10 | Lacosamide Tablets | 2 | 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
163 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized | 19 | 10 | 0 |
| 2 | Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized | 10 | 1 | 0 |
| 3 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized | 8 | 1 | 0 |
| 4 | Hubei Ye Zhen Tang Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 5 | Kyowa Kirin Co. Ltd | 6 | 1 | 0 |
| 6 | Shenzhen Ke Xing Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Jiangxi Di Kang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 2 | 0 |
| 9 | Bayer AG | 5 | 1 | 0 |
| 10 | Bristol-Myers Squibb Pharma EEIG | 5 | 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
89 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/09/29Import · Class 3.1 | 甘精胰岛素利司那肽注射液1:1 · No verified English nameJXSS2101024 | Sanofi K. K.; Sanofi-Aventis Deutschland GmbH; Sanofi (China) Investment Co. Ltd. |
| 2021/09/29Import · Class 1 | TJ271 注射液 · No verified English nameJXSL2101114 | I-MAB Biopharma US Limited; I-MAB Biopharm Co. Ltd |
| 2021/09/29Import · Class 2.2 | 古塞奇尤单抗注射液 · No verified English nameJXSL2101113 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/09/29Import · Class 2.2 | 古塞奇尤单抗注射液 · No verified English nameJXSL2101112 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/09/29Import · Class 1 | Paxalisib 胶囊 · No verified English nameJXHL2101194 | KAZIA THERAPEUTICS LIMITED; Jiangsu Simcere Pharmaceutical Co. Ltd. |
| 2021/09/29Import · Class 1 | ONC201胶囊 · No verified English nameJXHL2101193 | Sanjiu Healthy World Company Limited; China Resources Sanjiu Medical&Pharmaceutical Co. Ltd. |
| 2021/09/29Import · Class 1 | AM006 · No verified English nameJXHL2101192 | Affamed Therapeutics (US) Inc. |
| 2021/09/29Import · Class 1 | Avacopan硬胶囊 · No verified English nameJXHL2101190 | Vifor Fresenius Medical Care Renal Pharma Ltd.; Hangzhou Tigermed Consulting Co. Ltd. |
| 2021/09/29Import · Class 1 | IDX-1197 片 · No verified English nameJXHL2101189 | Idience Co. Ltd.; Syneos Health (Beijing)Inc. Ltd. |
| 2021/09/29Import · Class 1 | IDX-1197 片 · No verified English nameJXHL2101188 | Idience Co. Ltd.; Syneos Health (Beijing)Inc. Ltd. |
| 2021/09/29Import · Class 1 | IDX-1197 片 · No verified English nameJXHL2101187 | Idience Co. Ltd.; Syneos Health (Beijing)Inc. Ltd. |
| 2021/09/29Generic · Class 3 | Torsemide InjectionCYHS2101800 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2021/09/29Generic · Class 3 | Torsemide InjectionCYHS2101799 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2021/09/29Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2101796 | Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized |
| 2021/09/29Generic · Class 3 | Venlafaxine Hydrochloride Extended Release TabletsCYHS2101794 | Hefei Li Fang Pharmaceutical Co., Ltd. romanized |
| 2021/09/29Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2101793 | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2021/09/29Generic · Class 3 | Nicorandil for InjectionCYHS2101792 | Tianjin Tian Shi Li Zhi Jiao Pharma Co., Ltd. romanized |
| 2021/09/29Generic · Class 3 | Nicorandil for InjectionCYHS2101791 | Tianjin Tian Shi Li Zhi Jiao Pharma Co., Ltd. romanized |
| 2021/09/29Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2101790 | Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized |
| 2021/09/29Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2101789 | Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized |
| 2021/09/29Generic · Class 3 | Butorphanol Tartrate InjectionCYHS2101774 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2021/09/29Generic · Class 3 | Butorphanol Tartrate InjectionCYHS2101773 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2021/09/29Generic · Class 3 | Vasopressin InjectionCYHL2101029 | Chengdu Guo Wei Biopharmaceuticals Co., Ltd. romanized |
| 2021/09/29Generic · Class 3 | Topiroxostat TabletsCYHL2101028 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized |
| 2021/09/29Generic · Class 3 | Topiroxostat TabletsCYHL2101027 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized |
| 2021/09/29New drug · Class 1 | 镓[68Ga]纳坦重组PD-L1单域抗体注射液 · No verified English nameCXSL2101344 | Suzhou Zhi He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/29New drug · Class 2.2 | 盐酸右美托咪定鼻喷剂 · No verified English nameCXHS2101042 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/09/29New drug · Class 1 | 注射用BGC0228 · No verified English nameCXHL2101529 | Bo Rui Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/09/29New drug · Class 2.2 | 布立西坦缓释片 · No verified English nameCXHL2101527 | Tai Zhou Yue Yang Pharmaceuticals Kai Fa Co., Ltd. romanized |
| 2021/09/29New drug · Class 1 | ETH-155008片 · No verified English nameCXHL2101526 | Cheng Ke Pharma (Jiangsu) Co., Ltd. romanized |
59 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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