YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 197 drug applications between 14 April 2022 and 20 April 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 39, covering 27 drug names.
2022/04/14 – 2022/04/20
- New acceptances this week
- 197
- 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
197filings, 39 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 106 |
| Generic | 39 |
| New drug | 24 |
| Import | 11 |
| Import re-registration | 9 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 145 |
| TCM | 31 |
| Therapeutic biologic | 17 |
| Biologic | 2 |
| 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 | Oseltamivir Phosphate For Oral Suspension | 3 | 3 | 2 |
| 2 | Rivaroxaban Tablets | 3 | 1 | 3 |
| 3 | Palbociclib Tablets | 3 | 1 | 2 |
| 4 | Palbociclib Capsules | 3 | 1 | 0 |
| 5 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 3 | 1 | 2 |
| 6 | Tadalafil Tablets | 2 | 1 | 23 |
| 7 | Levetiracetam Tablets | 2 | 1 | 6 |
| 8 | Acetylcysteine Granules | 1 | 1 | 4 |
| 9 | Ebastine Oral Solution | 1 | 1 | 9 |
| 10 | Etoricoxib Tablets | 1 | 1 | 8 |
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 | Sichuan Tian Fu Kang Da Pharma Group Fu Qing Pharmaceutical Co., Ltd. romanized | 10 | 10 | 0 |
| 2 | Nanchang Bai Ji Pharmaceutical Co., Ltd. romanized | 8 | 7 | 0 |
| 3 | Qilu Pharmaceutical Co., Ltd. | 6 | 2 | 3 |
| 4 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 2 | 3 |
| 5 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 6 | MSN Laboratories Private Limited | 4 | 2 | 0 |
| 7 | Zhu Zhou Qian Jin Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Fresenius Kabi Austria GmbH | 4 | 1 | 0 |
| 9 | GUERBET | 4 | 1 | 0 |
| 10 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized | 3 | 1 | 3 |
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
43 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/04/20Import · Class 1 | U3-1402 · No verified English nameJXSL2200049 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2022/04/20Generic · Class 3 | Pirfenidone TabletsCYHS2200619 | Jiangsu Ziyond Pharmaceutical Co., Ltd. |
| 2022/04/20New drug · Class 2.2 | 重组结核杆菌融合蛋白(EC) · No verified English nameCXSL2200182 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2022/04/20New drug · Class 2.2 | 重组结核杆菌融合蛋白(EC) · No verified English nameCXSL2200181 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2022/04/20New drug · Class 2.2 | 重组结核杆菌融合蛋白(EC) · No verified English nameCXSL2200180 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2022/04/20New drug · Class 1 | PHP1003注射液 · No verified English nameCXSL2200179 | Suzhou Pu Le Kang Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/04/20New drug · Class 1 | M701 · No verified English nameCXSL2200178 | Wuhan You Zhi You Biopharmaceutical Co., Ltd. romanized |
| 2022/04/20New drug · Class 1 | GFH925片 · No verified English nameCXHL2200245 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2022/04/20New drug · Class 1 | GFH925片 · No verified English nameCXHL2200244 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2022/04/19Import · Class 1 | Pamrevlumab · No verified English nameJXSL2200048 | FibroGen Inc; FibroGen (China) Medical Technology Development CO. LTD. |
| 2022/04/19Generic · Class 3 | Piperacillin Sodium for InjectionCYHS2200615 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2022/04/19Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2200613 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2022/04/19Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2200612 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2022/04/19Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2200611 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2022/04/19Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2200606 | Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized |
| 2022/04/19New drug · Class 1 | 镓[68Ga]纳坦重组PD-L1单域抗体注射液 · No verified English nameCXSL2200176 | Suzhou Zhi He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/04/19New drug · Class 1 | SHR-1701注射液 · No verified English nameCXSL2200173 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2022/04/19New drug · Class 2.2 | RHYK2001 · No verified English nameCXHL2200242 | Ren He Yi Kang Group Co., Ltd. romanized |
| 2022/04/19New drug · Class 2.2 | 氨溴特罗口服滴剂 · No verified English nameCXHL2200222 | Ao Xin Yang Guang (Beijing) Pharma Technology Co., Ltd. romanized |
| 2022/04/18Generic · Class 3 | Memantine Hydrochloride Oral SolutionCYHS2200605 | Nanjing Rui Jie Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Hang Kang Pharma Co., Ltd. romanized |
| 2022/04/18Generic · Class 3 | Olprinone Hydrochloride InjectionCYHS2200601 | Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2022/04/18Generic · Class 3 | Palbociclib TabletsCYHS2200586 | Qilu Pharmaceutical Co., Ltd. |
| 2022/04/18Generic · Class 3 | Palbociclib TabletsCYHS2200585 | Qilu Pharmaceutical Co., Ltd. |
| 2022/04/18Generic · Class 3 | Palbociclib TabletsCYHS2200584 | Qilu Pharmaceutical Co., Ltd. |
| 2022/04/18New drug · Class 3.3 | 德谷门冬双胰岛素注射液 · No verified English nameCXSL2200172 | Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized |
| 2022/04/18New drug · Class 2.2 | 磷酸奥司他韦口溶膜 · No verified English nameCXHL2200241 | Qilu Pharmaceutical Co., Ltd. |
| 2022/04/18New drug · Class 2.2 | 磷酸奥司他韦口溶膜 · No verified English nameCXHL2200240 | Qilu Pharmaceutical Co., Ltd. |
| 2022/04/18New drug · Class 2.2 | 磷酸奥司他韦口溶膜 · No verified English nameCXHL2200239 | Qilu Pharmaceutical Co., Ltd. |
| 2022/04/18New drug · Class 1 | D-2570片 · No verified English nameCXHL2200238 | Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized |
| 2022/04/15Import · Class 3.1 | 达雷妥尤单抗注射液(皮下注射) · No verified English nameJXSS2200013 | Janssen-Cilag International NV; Cilag AG; Xian-Janssen Pharmaceutical Ltd. |
13 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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