YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 261 drug applications between 20 April 2022 and 26 April 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 49, covering 36 drug names.
2022/04/20 – 2022/04/26
- New acceptances this week
- 261
- Drugs with new generic filings (by drug name, de-duplicated)
- 36
- 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
261filings, 49 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 143 |
| Generic | 49 |
| New drug | 35 |
| Import | 14 |
| Unspecified | 13 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 191 |
| Therapeutic biologic | 37 |
| TCM | 23 |
| Biologic | 6 |
| Prophylactic biologic | 4 |
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
36 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Cariprazine hydrochloride Capsules | 4 | 1 | 3 |
| 2 | Cefminox Sodium for Injection | 3 | 1 | 0 |
| 3 | Pirfenidone Tablets | 2 | 2 | 5 |
| 4 | Tandospirone Citrate Tablets | 2 | 2 | 2 |
| 5 | 氧(液态) · No verified English name | 2 | 2 | 13 |
| 6 | Sodium Valproate Concentrated Solution for Injection | 2 | 1 | 0 |
| 7 | Tacrolimus Ointment | 2 | 1 | 6 |
| 8 | 司替戊醇干混悬剂 · No verified English name | 2 | 1 | 0 |
| 9 | Temozolomide Capsules | 2 | 1 | 0 |
| 10 | 磷酸奥司他韦干糖浆 · No verified English name | 2 | 1 | 0 |
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
164 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bristol-Myers Squibb Pharma EEIG | 8 | 2 | 0 |
| 2 | Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized | 7 | 1 | 0 |
| 3 | Hubei Hui Hai Pharmaceuticals Technology Research Institute Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Sichuan Tian Fu Kang Da Pharma Group Fu Qing Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Pfizer Inc. | 5 | 3 | 0 |
| 6 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. | 5 | 2 | 4 |
| 7 | GUERBET | 4 | 1 | 0 |
| 8 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Hainan Zhong Yue Medical Health Industry Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Nanjing Cheng Tong Biopharmaceutical Technology Development Co., Ltd. romanized | 3 | 2 | 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
68 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/04/26Import · Class 2.2 | 那西妥单抗注射液 · No verified English nameJXSL2200047 | Y-mAbs Therapeutics Inc.; SciClone Pharmaceuticals (China) Co. Ltd. |
| 2022/04/26Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2200660 | Shandong Tai Sheng Drug Research Co., Ltd. romanized; Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized |
| 2022/04/26Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2200659 | Shandong Tai Sheng Drug Research Co., Ltd. romanized; Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized |
| 2022/04/26New drug · Class 1 | HB0034注射液 · No verified English nameCXSL2200191 | Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2022/04/26New drug · Class 1 | HLX53 · No verified English nameCXSL2200190 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
| 2022/04/25Generic · Class 3 | Citicoline InjectionCYHS2200652 | Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2022/04/25Generic · Class 3 | Tranexamic Acid InjectionCYHS2200651 | Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2022/04/25Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2200649 | Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized |
| 2022/04/25New drug · Class 2.2 | 尼妥珠单抗注射液 · No verified English nameCXSS2200041 | Bai Tai Bio Pharma Co., Ltd. romanized |
| 2022/04/25New drug · Class 3.4 | 治疗用卡介苗 · No verified English nameCXSL2200188 | Chengdu Ke En Bio Technology Co., Ltd. romanized |
| 2022/04/25New drug · Class 2.2 | 盐酸伊立替康脂质体注射液 · No verified English nameCXHS2200019 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/04/25New drug · Class 1 | SC0062胶囊 · No verified English nameCXHL2200260 | Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized |
| 2022/04/25New drug · Class 1 | RJ4287片 · No verified English nameCXHL2200259 | Nanjing Ao Li Mo Si Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/04/25New drug · Class 1 | RJ4287片 · No verified English nameCXHL2200258 | Nanjing Ao Li Mo Si Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/04/25New drug · Class 1 | TSN333片 · No verified English nameCXHL2200257 | Tai Li Bio Technology (Shanghai) Co., Ltd. romanized |
| 2022/04/25New drug · Class 1 | TSN333片 · No verified English nameCXHL2200256 | Tai Li Bio Technology (Shanghai) Co., Ltd. romanized |
| 2022/04/24Import · Class 2.2 | Efgartigimod浓缩注射液 · No verified English nameJXSL2200050 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2022/04/24Import · Class 2.4 | 达罗他胺片 · No verified English nameJXHS2200041 | Bayer HealthCare Pharmaceuticals Inc.; Orion Corporation,Orion Pharma,Espoo; Bayer Healthcare Company Ltd. |
| 2022/04/24Import · Class 2.4 | Ibrexafungerp片 · No verified English nameJXHL2200090 | SCYNEXIS Inc.; JIANGSU HANSOH PHARMACEUTICAL GROUP CO. LTD |
| 2022/04/24Generic · Class 3 | Pirfenidone TabletsCYHS2200634 | Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized |
| 2022/04/24Generic · Class 3 | Cariprazine hydrochloride CapsulesCYHL2200039 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2022/04/24Generic · Class 3 | Cariprazine hydrochloride CapsulesCYHL2200038 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2022/04/24Generic · Class 3 | Cariprazine hydrochloride CapsulesCYHL2200037 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2022/04/24Generic · Class 3 | Cariprazine hydrochloride CapsulesCYHL2200036 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2022/04/24Generic · Class 3 | Regadenoson InjectionCYHL2200035 | Nanjing Rui Ke Wei Biopharmaceuticals Co., Ltd. romanized |
| 2022/04/24New drug · Class 3.3 | 肠道病毒71型灭活疫苗(Vero细胞) · No verified English nameCXSS2200043 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2022/04/24New drug · Class 3.3 | 肠道病毒71型灭活疫苗(Vero细胞) · No verified English nameCXSS2200042 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2022/04/24New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2200185 | Chongqing Pai Jin Bio Technology Co., Ltd. romanized; Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2022/04/24New drug · Class 1 | CMAB017注射液 · No verified English nameCXSL2200183 | Tai Zhou Mai Bo Tai Ke Pharma Co., Ltd. romanized |
| 2022/04/24New drug · Class 1 | 安达西尼胶囊 · No verified English nameCXHS2200018 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
38 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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