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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

Period
2022/04/14 to 2022/04/20, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
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 typeFilings
Supplement106
Generic39
New drug24
Import11
Import re-registration9
Unspecified8

By drug type

Drug typeFilings
Chemical drug145
TCM31
Therapeutic biologic17
Biologic2
Prophylactic biologic2

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

#DrugNew generic filingsFiling companiesUnder review, all years
1Oseltamivir Phosphate For Oral Suspension332
2Rivaroxaban Tablets313
3Palbociclib Tablets312
4Palbociclib Capsules310
5盐酸左沙丁胺醇雾化吸入溶液 · No verified English name312
6Tadalafil Tablets2123
7Levetiracetam Tablets216
8Acetylcysteine Granules114
9Ebastine Oral Solution119
10Etoricoxib Tablets118

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)FilingsDrugsGeneric
1Sichuan Tian Fu Kang Da Pharma Group Fu Qing Pharmaceutical Co., Ltd. romanized10100
2Nanchang Bai Ji Pharmaceutical Co., Ltd. romanized870
3Qilu Pharmaceutical Co., Ltd.623
4CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD523
5Boehringer Ingelheim International GmbH510
6MSN Laboratories Private Limited420
7Zhu Zhou Qian Jin Pharma Co., Ltd. romanized420
8Fresenius Kabi Austria GmbH410
9GUERBET410
10Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized313

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

AcceptedDrugApplicants
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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