YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 300 drug applications between 13 January 2022 and 19 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 58, covering 42 drug names.
2022/01/13 – 2022/01/19
- New acceptances this week
- 300
- Drugs with new generic filings (by drug name, de-duplicated)
- 42
- 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
300filings, 58 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 168 |
| Generic | 58 |
| New drug | 37 |
| Import | 17 |
| Import re-registration | 14 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 238 |
| Therapeutic biologic | 33 |
| TCM | 23 |
| Prophylactic biologic | 5 |
| In vitro diagnostic reagent | 1 |
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
42 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Memantine Hydrochloride Sustained-release Capsules | 4 | 1 | 2 |
| 2 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 3 | Rivaroxaban Tablets | 2 | 2 | 3 |
| 4 | Atomoxetine Hydrochloride Oral Solution | 2 | 2 | 0 |
| 5 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
| 6 | 吸入用七氟烷 · No verified English name | 2 | 1 | 0 |
| 7 | Empagliflozin Tablets | 2 | 1 | 18 |
| 8 | Parecoxib Sodium for Injection | 2 | 1 | 2 |
| 9 | Neostigmine Methylsulfate Injection | 2 | 1 | 4 |
| 10 | Edoxaban Tosilate Tablets | 2 | 1 | 9 |
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
176 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Rui Ze Pharma Co., Ltd. romanized | 22 | 21 | 0 |
| 2 | Guangxi Kun Ze Pharma Co., Ltd. romanized | 12 | 2 | 0 |
| 3 | Bayer Vital GmbH | 9 | 2 | 0 |
| 4 | Hainan Tong Yong San Yang Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 5 | Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | LES LABORATOIRES SERVIER | 4 | 3 | 0 |
| 7 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc | 4 | 2 | 0 |
| 8 | AstraZeneca AB | 4 | 1 | 0 |
| 9 | Janssen Pharmaceuticals Inc. | 4 | 1 | 0 |
| 10 | PFIZER EUROPE MA EEIG | 4 | 1 | 0 |
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
66 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/01/19Import · Class 3.4 | 达雷妥尤单抗注射液(皮下注射) · No verified English nameJXSL2200010 | Janssen Research & Development LLC; Johnson &Johnson(China)Investment Ltd. |
| 2022/01/19Import · Class 1 | MBG453 · No verified English nameJXSL2200009 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/01/19Import · Class 1 | NIS793 · No verified English nameJXSL2200008 | Novartis Pharma AG; China Novartis Institutes for BioMedical Reasearch Co. Ltd |
| 2022/01/19Import · Class 1 | Pritelivir薄膜包衣片 · No verified English nameJXHL2200021 | AiCuris Anti-infective Cures AG; Beijing Medpace Co.Ltd |
| 2022/01/19New drug · Class 1 | 阿得贝利单抗注射液 · No verified English nameCXSS2200006 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized; Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2022/01/19New drug · Class 1 | 注射用BC004 · No verified English nameCXSL2200026 | Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized |
| 2022/01/19New drug · Class 1 | 注射用KL031322 · No verified English nameCXHL2200033 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2022/01/18Generic · Class 3 | 泽布替尼胶囊 · No verified English nameCYHS2200112 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2022/01/18Generic · Class 3 | Oxycodone And Acetaminophen TabletsCYHS2200109 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2022/01/18Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2200108 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2022/01/18Generic · Class 3 | Memantine Hydrochloride Sustained-release CapsulesCYHS2200089 | Nan Tong Lian Ya Pharma Co., Ltd. romanized |
| 2022/01/18Generic · Class 3 | Memantine Hydrochloride Sustained-release CapsulesCYHS2200088 | Nan Tong Lian Ya Pharma Co., Ltd. romanized |
| 2022/01/18Generic · Class 3 | Memantine Hydrochloride Sustained-release CapsulesCYHS2200087 | Nan Tong Lian Ya Pharma Co., Ltd. romanized |
| 2022/01/18Generic · Class 3 | Memantine Hydrochloride Sustained-release CapsulesCYHS2200086 | Nan Tong Lian Ya Pharma Co., Ltd. romanized |
| 2022/01/18Generic · Class 3 | 米诺地尔泡沫剂 · No verified English nameCYHS2200045 | Zhejiang Wan Cheng Pharma Co., Ltd. romanized |
| 2022/01/18Generic · Class 3 | Bromhexine Hydrochloride Solution For InhalationCYHL2200008 | Wan Bang De Pharmaceutical Group Co., Ltd. romanized |
| 2022/01/18New drug · Class 1 | KL-A167注射液 · No verified English nameCXSL2200025 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2022/01/18New drug · Class 1 | 注射用SKB264 · No verified English nameCXSL2200024 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2022/01/18New drug · Class 1 | SMP-100片 · No verified English nameCXHL2200032 | Ke Ling Yuan Bio Technology (Shenzhen) Co., Ltd. romanized |
| 2022/01/18New drug · Class 1 | DAJH-1050766片 · No verified English nameCXHL2200031 | Chengdu Di Ao Jiu Hong Pharmaceutical Factory romanized |
| 2022/01/18New drug · Class 1 | DAJH-1050766片 · No verified English nameCXHL2200030 | Chengdu Di Ao Jiu Hong Pharmaceutical Factory romanized |
| 2022/01/18New drug · Class 2.4 | 优替德隆注射液 · No verified English nameCXHL2200029 | Chengdu Hua Hao Zhong Tian Pharma Co., Ltd. romanized |
| 2022/01/18New drug · Class 2.4 | 优替德隆注射液 · No verified English nameCXHL2200028 | Chengdu Hua Hao Zhong Tian Pharma Co., Ltd. romanized |
| 2022/01/18New drug · Class 1 | TQB3915片 · No verified English nameCXHL2200027 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2022/01/18New drug · Class 1 | TQB3915片 · No verified English nameCXHL2200026 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2022/01/18New drug · Class 2.2 | 利培酮口溶膜 · No verified English nameCXHL2200015 | Qilu Pharmaceutical Co., Ltd. |
| 2022/01/18New drug · Class 2.2 | 利培酮口溶膜 · No verified English nameCXHL2200014 | Qilu Pharmaceutical Co., Ltd. |
| 2022/01/17Import · Class 1 | VAY736注射液 · No verified English nameJXSL2200007 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/01/17Import · Class 1 | RO7191863注射液 · No verified English nameJXHL2200020 | F. Hoffmann-La Roche Ltd.; Roche R & D Center (China) Ltd. |
| 2022/01/17Import · Class 1 | RO7445482注射液 · No verified English nameJXHL2200019 | F. Hoffmann-La Roche Ltd.; Roche R & D Center (China) Ltd. |
36 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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