YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 267 drug applications between 17 January 2022 and 23 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 58, covering 40 drug names.
2022/01/17 – 2022/01/23
- New acceptances this week
- 267
- Drugs with new generic filings (by drug name, de-duplicated)
- 40
- 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
267filings, 58 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 147 |
| Generic | 58 |
| New drug | 31 |
| Import | 17 |
| Import re-registration | 10 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 204 |
| TCM | 29 |
| Therapeutic biologic | 27 |
| Prophylactic biologic | 7 |
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
40 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 | Rivaroxaban Tablets | 3 | 1 | 3 |
| 3 | Enoxaparin Sodium Injection | 2 | 1 | 16 |
| 4 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
| 5 | Empagliflozin Tablets | 2 | 1 | 18 |
| 6 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 7 | Parecoxib Sodium for Injection | 2 | 1 | 2 |
| 8 | Neostigmine Methylsulfate Injection | 2 | 1 | 4 |
| 9 | Dopamine Hydrochloride Injection | 2 | 1 | 3 |
| 10 | Lurasidone Hydrochloride Tablets | 2 | 1 | 2 |
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
149 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Rui Ze Pharma Co., Ltd. romanized | 14 | 13 | 0 |
| 2 | Hubei Tai Zi Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 3 | Bayer Vital GmbH | 7 | 1 | 0 |
| 4 | Diao Yu Tai Pharmaceuticals Group Jilin Tian Qiang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 6 | Hainan Tong Yong San Yang Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 8 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 3 | 0 |
| 9 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc | 4 | 2 | 0 |
| 10 | AstraZeneca AB | 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
65 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/01/21Generic · Class 3 | Carbocisteine Oral SolutionCYHS2200153 | Guangdong Hua Nan Pharma Group Co., Ltd. romanized; Guangdong Zhong Sheng Pharma Co., Ltd. romanized |
| 2022/01/21Generic · Class 3 | Carbocisteine Oral SolutionCYHS2200152 | Guangdong Hua Nan Pharma Group Co., Ltd. romanized; Guangdong Zhong Sheng Pharma Co., Ltd. romanized |
| 2022/01/21Generic · Class 3 | Efavirenz Lamivudine and tenofovir Disoproxil Fumarate TabletsCYHS2200146 | Shanghai Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized |
| 2022/01/21Generic · Class 3 | Desmopressin Acetate Oral SolutionCYHS2200141 | Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2022/01/21New drug · Class 1 | 注射用重组人源化抗HER2单抗-AS269偶联物(ARX788) · No verified English nameCXSL2200033 | Zhejiang Xin Ma Biopharmaceuticals Co., Ltd. romanized |
| 2022/01/21New drug · Class 1 | IBI319 · No verified English nameCXSL2200030 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2022/01/21New drug · Class 2.4 | 环泊酚注射液 · No verified English nameCXHS2200006 | Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2022/01/21New drug · Class 2.4 | 硫酸阿托品滴眼液 · No verified English nameCXHL2200035 | Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized |
| 2022/01/21New drug · Class 2.4 | 硫酸阿托品滴眼液 · No verified English nameCXHL2200034 | Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized |
| 2022/01/20Import · Class 2.4 | Tucatinib片 · No verified English nameJXHL2200025 | Seagen Inc.; MSD R&D (China) Co. Ltd. |
| 2022/01/20Import · Class 2.4 | Tucatinib片 · No verified English nameJXHL2200024 | Seagen Inc.; MSD R&D (China) Co. Ltd. |
| 2022/01/20Import · Class 1 | venglustat · No verified English nameJXHL2200023 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd |
| 2022/01/20Import · Class 1 | venglustat · No verified English nameJXHL2200022 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd |
| 2022/01/20Generic · Class 3 | Desonide CreamCYHS2200138 | Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized |
| 2022/01/20Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2200134 | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized |
| 2022/01/20Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2200133 | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized |
| 2022/01/20Generic · Class 3 | Peramivir InjectionCYHS2200121 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2022/01/20New drug · Class 1 | IBI321 · No verified English nameCXSL2200028 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2022/01/20New drug · Class 3.3 | 13价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2200027 | Chengdu Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2022/01/20New drug · Class 1 | QR056251胶囊 · No verified English nameCXHL2200039 | Wuhan Lang Lai Technology Development Co., Ltd. romanized |
| 2022/01/20New drug · Class 1 | QR056251胶囊 · No verified English nameCXHL2200038 | Wuhan Lang Lai Technology Development Co., Ltd. romanized |
| 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 |
35 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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