YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 200 drug applications between 31 December 2021 and 6 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 36, covering 25 drug names.
2021/12/31 – 2022/01/06
- New acceptances this week
- 200
- Drugs with new generic filings (by drug name, de-duplicated)
- 25
- 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
200filings, 36 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 93 |
| New drug | 47 |
| Generic | 36 |
| Import | 15 |
| Import re-registration | 8 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 146 |
| Therapeutic biologic | 39 |
| TCM | 15 |
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
25 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Gabapentin Capsules | 3 | 1 | 0 |
| 2 | Enarodustat Tablets | 3 | 1 | 0 |
| 3 | Losartan Potassium and Hydrochlorothiazide Tablets | 3 | 1 | 1 |
| 4 | Nicorandil for Injection | 3 | 1 | 1 |
| 5 | 地氯雷他定口服溶液 · No verified English name | 2 | 2 | 26 |
| 6 | Metoprolol Tartrate Tablets | 2 | 2 | 3 |
| 7 | Dobutamine Hydrochloride Injection | 2 | 1 | 3 |
| 8 | Lactulose Oral Solution | 1 | 1 | 34 |
| 9 | Voriconazole for Oral Suspension | 1 | 1 | 1 |
| 10 | Compound Ipratropium Bromide Solution For Inhalation | 1 | 1 | 4 |
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
125 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Henan Fu Ren Tang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 2 | Shandong Run Ze Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 3 | Pfizer Europe MA EEIG | 4 | 2 | 0 |
| 4 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 5 | Nian Yan Pharma (Zhuhai) Co., Ltd. romanized | 4 | 1 | 0 |
| 6 | Shenzhen Ming Sai Rui Lin Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 7 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 3 | 3 | 3 |
| 8 | Hubei Rui Ze Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Boehringer Ingelheim International GmbH | 3 | 2 | 0 |
| 10 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 3 | 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
67 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/01/06Import · Class 1 | MRTX849片 · No verified English nameJXHL2200006 | Mirati Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2022/01/06Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2200014 | Guizhou Fu Kang Ren Pharmaceutical Co., Ltd. romanized; Shandong Yi Kang Pharma Co., Ltd. romanized |
| 2022/01/06New drug · Class 1 | PM1015 注射液 · No verified English nameCXSL2200006 | Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2022/01/06New drug · Class 1 | HLX301 · No verified English nameCXSL2200005 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
| 2022/01/06New drug · Class 1 | 重组人源化抗PD-L1单克隆抗体/人TGF-β融合蛋白注射液 · No verified English nameCXSL2101535 | Le Pu Bio Technology Co., Ltd. romanized |
| 2022/01/06New drug · Class 1 | CP0119片 · No verified English nameCXHL2200008 | Nan Kai University romanized |
| 2022/01/06New drug · Class 1 | CP0119片 · No verified English nameCXHL2200007 | Nan Kai University romanized |
| 2022/01/05Import · Class 1 | 输注用无菌冻干粉Telisotuzumab vedotin · No verified English nameJXSL2200002 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai)Co. Ltd |
| 2022/01/05Import · Class 1 | SQZ-AAC-HPV · No verified English nameJXSL2200001 | SQZ Biotechnologies Company; ICON Clinical Research (Beijing No.2) Co. Ltd. |
| 2022/01/05Import · Class 1 | SHR8008胶囊 · No verified English nameJXHS2101101 | eVENUS PHARMACEUTICAL LABORATORIES INC.; PATHEON INC.; Jiangsu Hengrui Pharmaceuticals Co. Ltd |
| 2022/01/05Import · Class 1 | ATG-016片 · No verified English nameJXHL2200002 | Karyopharm Therapeutics Inc.; Shanghai Antengene Corporation Limited |
| 2022/01/05Import · Class 1 | ATG-016片 · No verified English nameJXHL2200001 | Karyopharm Therapeutics Inc.; Shanghai Antengene Corporation Limited |
| 2022/01/05Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2200008 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2022/01/05Generic · Class 3 | Loxoprofen sodium hydrate gelCYHS2102309 | Jiangsu Fu Bang Pharma Co., Ltd. romanized |
| 2022/01/05New drug · Class 1.2 | 岩藻多糖胶囊 · No verified English nameCXZL2200002 | Wei Hai Ren Sheng Pharma Co., Ltd. romanized |
| 2022/01/05New drug · Class 1.2 | 岩藻多糖硫酸酯 · No verified English nameCXZL2200001 | Wei Hai Ren Sheng Pharma Co., Ltd. romanized |
| 2022/01/05New drug · Class 3.3 | 阿柏西普眼内注射溶液 · No verified English nameCXSL2200003 | Zhi En Bio Technology Co., Ltd. romanized |
| 2022/01/05New drug · Class 1 | SK08活菌散 · No verified English nameCXSL2200001 | Guangzhou Zhi Yi Bio Technology Co., Ltd. romanized |
| 2022/01/05New drug · Class 1 | TQB2618注射液 · No verified English nameCXSL2101537 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2022/01/05New drug · Class 2.3 | 可溶性甘精赖脯双胰岛素注射液 · No verified English nameCXSL2101513 | Tong Hua Dong Bao Pharma Co., Ltd. romanized |
| 2022/01/05New drug · Class 1 | HRS-7535片 · No verified English nameCXHL2200006 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/01/05New drug · Class 1 | HRS-7535片 · No verified English nameCXHL2200005 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/01/05New drug · Class 1 | NT-004片 · No verified English nameCXHL2200004 | Nian Yan Pharma (Zhuhai) Co., Ltd. romanized |
| 2022/01/05New drug · Class 1 | NT-004片 · No verified English nameCXHL2200003 | Nian Yan Pharma (Zhuhai) Co., Ltd. romanized |
| 2022/01/05New drug · Class 1 | NT-004片 · No verified English nameCXHL2200002 | Nian Yan Pharma (Zhuhai) Co., Ltd. romanized |
| 2022/01/05New drug · Class 1 | NT-004片 · No verified English nameCXHL2200001 | Nian Yan Pharma (Zhuhai) Co., Ltd. romanized |
| 2022/01/05New drug · Class 1 | WXFL10030390片 · No verified English nameCXHL2101861 | Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/01/05New drug · Class 1 | WXFL10030390片 · No verified English nameCXHL2101860 | Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/01/05New drug · Class 1 | 希列克托灵片 · No verified English nameCXHL2101833 | Shenzhen Ming Sai Rui Lin Pharma Co., Ltd. romanized |
| 2022/01/05New drug · Class 1 | 希列克托灵片 · No verified English nameCXHL2101832 | Shenzhen Ming Sai Rui Lin Pharma Co., Ltd. romanized |
37 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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