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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 238 drug applications between 3 July 2022 and 9 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 41, covering 28 drug names.

2022/07/03 – 2022/07/09

Period
2022/07/03 to 2022/07/09, 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
238
Drugs with new generic filings (by drug name, de-duplicated)
28
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

238filings, 41 of them generic

By application type

Application typeFilings
Supplement107
Generic41
New drug35
Import21
Import re-registration21
Unspecified13

By drug type

Drug typeFilings
Chemical drug183
Therapeutic biologic29
TCM17
Biologic5
Prophylactic biologic4

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

28 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Urapidil Hydrochloride Injection636
2Rivaroxaban Tablets313
3Indobufen Tablets216
4Ornidazole Injection210
5Levetiracetam extended-release tablets210
6Paliperidone Extend-release Tablets212
7Escitalopram Oxalate Tablets216
8Ketorolac Tromethamine Injection214
9Sodium Valproate Oral Solution111
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

135 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1MUNDIPHARMA GmbH910
2Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized880
3Novo Nordisk A/S540
4Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized530
5Shijiazhuang No.4 Pharmaceutical Co., Ltd.532
6AstraZeneca UK Limited520
7Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized440
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

62 this week

AcceptedDrugApplicants
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.
2022/07/07Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2201030 Chongqing Zhong Chuang Ke Pharmaceuticals Co., Ltd. romanized; Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
2022/07/07Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2201029 Chongqing Zhong Chuang Ke Pharmaceuticals Co., Ltd. romanized; Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
2022/07/07Generic · Class 3 维生素K滴剂 · No verified English nameCYHS2201025 Guangxi Ming Lei Wei Sheng Pharmaceutical Co., Ltd. romanized
2022/07/07New drug · Class 1.2 重组水痘疫苗(CHO细胞) · No verified English nameCXSL2200314 Beijing Lv Zhu Bio Technology Co., Ltd. romanized
2022/07/07New drug · Class 1 GB5005嵌合抗原受体T细胞注射液 · No verified English nameCXSL2200313 Shanghai Ji Bei Bio Technology Co., Ltd. romanized
2022/07/07New drug · Class 1 BGC1201片 · No verified English nameCXHL2200490 Gan Jiang Xin Qu Bo Rui Innovation Pharmaceuticals Co., Ltd. romanized
2022/07/07New drug · Class 1 RG002片 · No verified English nameCXHL2200489 Shanghai Ling Ji Bio Technology Co., Ltd. romanized; Shanghai Ling Da Biopharmaceuticals Co., Ltd. romanized
2022/07/07New drug · Class 1 RG002片 · No verified English nameCXHL2200488 Shanghai Ling Ji Bio Technology Co., Ltd. romanized; Shanghai Ling Da Biopharmaceuticals Co., Ltd. romanized
2022/07/07New drug · Class 1 BT-114143注射液 · No verified English nameCXHL2200487 Sai Nuo Ha Bo Pharma (Chengdu) Co., Ltd. romanized
2022/07/06Import · Class 2.2 Efgartigimod浓缩注射液 · No verified English nameJXSL2200103 argenx BV; Zai Lab (Shanghai) Co. Ltd.
2022/07/06Generic · Class 3 Nicorandil for InjectionCYHS2201022 Suzhou Te Rui Pharma Co., Ltd. romanized; Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanized
2022/07/06Generic · Class 3 利伐沙班颗粒 · No verified English nameCYHS2200991 Jiangxi Shimei Pharmaceutical Co., Ltd
2022/07/06New drug · Class 1 伊立珠单抗注射液 · No verified English nameCXSL2200311 Bai Tai Bio Pharma Co., Ltd. romanized
2022/07/06New drug · Class 1 PA3670片 · No verified English nameCXHL2200486 Zhejiang Bai La A Tu Pharmaceuticals Technology Co., Ltd. romanized
2022/07/06New drug · Class 1 ICP-248片 · No verified English nameCXHL2200485 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2022/07/06New drug · Class 1 ICP-248片 · No verified English nameCXHL2200484 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2022/07/06New drug · Class 1 ICP-248片 · No verified English nameCXHL2200483 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2022/07/05Import · Class 1 RO6868847薄膜包衣片 · No verified English nameJXHL2200174 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/07/05Import · Class 1 RO6868847薄膜包衣片 · No verified English nameJXHL2200173 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.

32 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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