YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 211 drug applications between 17 April 2022 and 23 April 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 42, covering 31 drug names.

2022/04/17 – 2022/04/23

Period
2022/04/17 to 2022/04/23, 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
211
Drugs with new generic filings (by drug name, de-duplicated)
31
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

211filings, 42 of them generic

By application type

Application typeFilings
Supplement120
Generic42
New drug26
Import13
Unspecified6
Import re-registration4

By drug type

Drug typeFilings
Chemical drug154
TCM28
Therapeutic biologic26
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

31 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
4Levodopa and Benserazide Hydrochloride Tablets222
5Tadalafil Tablets2123
6司替戊醇干混悬剂 · No verified English name210
7Levetiracetam Tablets216
8磷酸奥司他韦干糖浆 · No verified English name210
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

124 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
3Yi Chang Ren Fu Pharma Co., Ltd. romanized723
4Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized710
5Qilu Pharmaceutical Co., Ltd.623
6GUERBET410
7Hubei Hui Hai Pharmaceuticals Technology Research Institute Co., Ltd. romanized330
8Merck Sharp & Dohme Corp.320
9Nanjing Cheng Tong Biopharmaceutical Technology Development Co., Ltd. romanized320
10SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED320

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

55 this week

AcceptedDrugApplicants
2022/04/22Import · Class 3.1 纳武利尤单抗注射液 · No verified English nameJXSS2200015 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China)Investment Co. Ltd
2022/04/22Import · Class 3.1 纳武利尤单抗注射液 · No verified English nameJXSS2200014 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China)Investment Co. Ltd
2022/04/22Import · Class 1 Fosmanogepix 注射液 · No verified English nameJXHL2200089 Pfizer Inc.; Pfizer Investment CO. Ltd
2022/04/22Import · Class 1 Fosmanogepix 片 · No verified English nameJXHL2200088 Pfizer Inc.; Pfizer Investment CO. Ltd
2022/04/22Generic · Class 3 Nifedipine Extended-Release TabletsCYHS2200633 Ya Bao Pharma Group Co., Ltd. romanized
2022/04/22Generic · Class 3 Levetiracetam in Sodium Chloride InjectionCYHS2200632 Guizhou Fu Kang Ren Pharmaceutical Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2022/04/22Generic · Class 3 磷酸奥司他韦干糖浆 · No verified English nameCYHS2200631 Di Kang Bei (Suzhou) Biopharmaceuticals Technology Co., Ltd. romanized; Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2022/04/22Generic · Class 3 磷酸奥司他韦干糖浆 · No verified English nameCYHS2200630 Di Kang Bei (Suzhou) Biopharmaceuticals Technology Co., Ltd. romanized; Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2022/04/22Generic · Class 3 酮康唑泡沫剂 · No verified English nameCYHL2200033 Guangdong Hong Shan Hu Pharma Co., Ltd. romanized
2022/04/22New drug · Class 3.3 贝伐珠单抗注射液 · No verified English nameCXSS2200040 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2022/04/22New drug · Class 1 注射用BAT8010 · No verified English nameCXSL2200184 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2022/04/22New drug · Class 1 重组人神经调节蛋白-1-抗HER3抗体融合蛋白注射液 · No verified English nameCXSL2200177 Xin Li Tai (Chengdu) Bio Technology Co., Ltd. romanized; Xin Li Tai (Suzhou) Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/04/22New drug · Class 1 注射用CIGB-814 · No verified English nameCXHL2200251 Shandong Lukang Pharmaceutical Co.,Ltd.
2022/04/22New drug · Class 1 BR790片 · No verified English nameCXHL2200250 Shanghai Ge Fei Mu Biopharmaceuticals Technology Co., Ltd. romanized
2022/04/22New drug · Class 1 RFUS-144注射液 · No verified English nameCXHL2200249 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/04/22New drug · Class 1 RFUS-144注射液 · No verified English nameCXHL2200248 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/04/22New drug · Class 2.2 T19 · No verified English nameCXHL2200243 Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized
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

25 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.