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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 201 drug applications between 15 April 2022 and 21 April 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 41, covering 32 drug names.

2022/04/15 – 2022/04/21

Period
2022/04/15 to 2022/04/21, 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
201
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

201filings, 41 of them generic

By application type

Application typeFilings
Supplement108
Generic41
New drug23
Import13
Unspecified8
Import re-registration8

By drug type

Drug typeFilings
Chemical drug146
TCM31
Therapeutic biologic21
Biologic2
Prophylactic biologic1

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

#DrugNew generic filingsFiling companiesUnder review, all years
1Rivaroxaban Tablets313
2Palbociclib Tablets312
3盐酸左沙丁胺醇雾化吸入溶液 · No verified English name312
4Tadalafil Tablets2123
5司替戊醇干混悬剂 · No verified English name210
6Levetiracetam Tablets216
7Acetylcysteine Granules114
8Ebastine Oral Solution119
9Etoricoxib Tablets118
10Capecitabine Tablets110

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

122 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan Tian Fu Kang Da Pharma Group Fu Qing Pharmaceutical Co., Ltd. romanized15140
2Nanchang Bai Ji Pharmaceutical Co., Ltd. romanized870
3Qilu Pharmaceutical Co., Ltd.623
4Yi Chang Ren Fu Pharma Co., Ltd. romanized523
5Boehringer Ingelheim International GmbH510
6MSN Laboratories Private Limited420
7Fresenius Kabi Austria GmbH410
8GUERBET410
9Merck Sharp & Dohme Corp.320
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

46 this week

AcceptedDrugApplicants
2022/04/21Import · Class 1 BLU-945胶囊 · No verified English nameJXHL2200087 Blueprint Medicines Corporation; Zai Lab (Shanghai) CO. Ltd.
2022/04/21Import · Class 1 BLU-945胶囊 · No verified English nameJXHL2200086 Blueprint Medicines Corporation; Zai Lab (Shanghai) CO. Ltd.
2022/04/21Generic · Class 3 非洛地平片 · No verified English nameCYHS2200623 Hunan Jiudian Pharmaceutical Co., Ltd
2022/04/21Generic · Class 3 Milrinone InjectionCYHS2200620 Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized
2022/04/21Generic · Class 3 司替戊醇干混悬剂 · No verified English nameCYHS2200618 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/04/21Generic · Class 3 司替戊醇干混悬剂 · No verified English nameCYHS2200617 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/04/21Generic · Class 3 Epinastine Hydrochloride Eye DropsCYHL2200034 Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized
2022/04/21New drug · Class 1 RFUS-144注射液 · No verified English nameCXHL2200247 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/04/21New drug · Class 1 RFUS-144注射液 · No verified English nameCXHL2200246 Yi Chang Ren Fu Pharma Co., Ltd. romanized
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

16 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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