YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 240 drug applications between 5 July 2022 and 11 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 45, covering 34 drug names.

2022/07/05 – 2022/07/11

Period
2022/07/05 to 2022/07/11, 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
240
Drugs with new generic filings (by drug name, de-duplicated)
34
Accepted this week, now under review
1

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

240filings, 45 of them generic

By application type

Application typeFilings
Supplement108
Generic45
New drug33
Import25
Import re-registration17
Unspecified12

By drug type

Drug typeFilings
Chemical drug177
Therapeutic biologic34
TCM21
Biologic5
Prophylactic biologic3

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

34 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Rivaroxaban Tablets313
2Hydromorphone Hydrochloride Extended-Release Tablets310
3Glucosamine Sulfate Capsules2251
4Indobufen Tablets216
5Ornidazole Injection210
6Urapidil Hydrochloride Injection216
7Escitalopram Oxalate Tablets216
8Calcium Gluconate in Sodium Chloride Injection215
9Ketorolac Tromethamine Injection214
10低钙腹膜透析液(乳酸盐-G1.5%) · No verified English name113

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

144 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized880
2Yi Chang Ren Fu Pharma Co., Ltd. romanized733
3Shijiazhuang No.4 Pharmaceutical Co., Ltd.643
4Novo Nordisk A/S540
5LES LABORATOIRES SERVIER530
6AstraZeneca UK Limited520
7CSL Behring GmbH510
8Pfizer Europe MA EEIG430
9F. Hoffmann-La Roche Ltd420
10Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized420

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

69 this week

AcceptedDrugApplicants
2022/07/11Import · Class 3.1 注射用重组人凝血因子IX-白蛋白融合蛋白 · No verified English nameJXSL2200118 CSL Behring GmbH; PAREXEL CHINA CO. LTD
2022/07/11Import · Class 3.1 注射用重组人凝血因子IX-白蛋白融合蛋白 · No verified English nameJXSL2200117 CSL Behring GmbH; PAREXEL CHINA CO. LTD
2022/07/11Import · Class 3.1 注射用重组人凝血因子IX-白蛋白融合蛋白 · No verified English nameJXSL2200116 CSL Behring GmbH; PAREXEL CHINA CO. LTD
2022/07/11Import · Class 3.1 注射用重组人凝血因子IX-白蛋白融合蛋白 · No verified English nameJXSL2200115 CSL Behring GmbH; PAREXEL CHINA CO. LTD
2022/07/11Import · Class 3.1 注射用重组人凝血因子IX-白蛋白融合蛋白 · No verified English nameJXSL2200114 CSL Behring GmbH; PAREXEL CHINA CO. LTD
2022/07/11Generic · Class 3 Hydromorphone Hydrochloride Extended-Release TabletsCYHS2201047 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/07/11Generic · Class 3 Hydromorphone Hydrochloride Extended-Release TabletsCYHS2201046 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/07/11Generic · Class 3 Hydromorphone Hydrochloride Extended-Release TabletsCYHS2201045 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/07/11Generic · Class 3 Terlipressin Acetate InjectionCYHS2201042 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized
2022/07/11Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2201041 Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanized
2022/07/11Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2201040 Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanized
2022/07/11Generic · Class 3 Florbetaben F-18 InjectionCYHS2201037 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized; Tianjin Yuan Zi Gao Ke Tong Wei Su Pharmaceuticals Co., Ltd. romanized
2022/07/11Generic · Class 3 Mometasone Furoate CreamCYHS2201026 Fu Yuan Pharma Co., Ltd. romanized
2022/07/11Generic · Class 3 Pregabalin Extended release TabletsCYHL2200057 Qilu Pharmaceutical Co., Ltd.
2022/07/11Generic · Class 3 盐酸溴己新雾化吸入溶液 · No verified English nameCYHL2200056 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2022/07/11New drug · Class 3.3 注射用依那西普 · No verified English nameCXSS2200063 Qilu Pharmaceutical Co., Ltd.
2022/07/11New drug · Class 1 BC008-1A注射液 · No verified English nameCXSL2200315 Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized
2022/07/11New drug · Class 1 PM1009注射液 · No verified English nameCXSL2200312 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2022/07/11New drug · Class 1 注射用KH617 · No verified English nameCXHL2200491 Sichuan Hong He Bio Technology Co., Ltd. romanized
2022/07/08Generic · Class 3 Ornidazole InjectionCYHS2201034 Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized
2022/07/08Generic · Class 3 Ornidazole InjectionCYHS2201033 Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized
2022/07/08Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2201032 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2022/07/08Generic · Class 3 Arbidol Hydrochloride TabletsCYHS2201031 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/07/08New drug · Class 1 SHR8554注射液 · No verified English nameCXHS2200038 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/07/08New drug · Class 1 SHR8554注射液 · No verified English nameCXHS2200037 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/07/07Import · Class 2.2 萨特利珠单抗注射液 · No verified English nameJXSL2200113 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/07/07Import · Class 2.2 萨特利珠单抗注射液 · No verified English nameJXSL2200112 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/07/07Import · Class 1 Modakafusp Alfa注射液(TAK-573) · No verified English nameJXSL2200111 Takeda Development Center Americas Inc.; Takeda(China) International Trading Co. Ltd
2022/07/07Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2200110 Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd.
2022/07/07Import · Class 1 MK-4830注射液 · No verified English nameJXSL2200109 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.

39 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.