YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 280 drug applications between 20 September 2022 and 26 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 49, covering 42 drug names.
2022/09/20 – 2022/09/26
- New acceptances this week
- 280
- 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
280filings, 49 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 135 |
| New drug | 51 |
| Generic | 49 |
| Import | 20 |
| Unspecified | 17 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 195 |
| Therapeutic biologic | 38 |
| TCM | 32 |
| Biologic | 14 |
| 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 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 2 | Allopurinol Tablets | 2 | 1 | 4 |
| 3 | Dopamine Hydrochloride Injection | 2 | 1 | 3 |
| 4 | Calcium Gluconate in Sodium Chloride Injection | 2 | 1 | 5 |
| 5 | Cytarabine Injection | 2 | 1 | 0 |
| 6 | Choline Fenofibrate Sustained-release Capsules | 2 | 1 | 1 |
| 7 | Acetylcysteine Granules | 1 | 1 | 4 |
| 8 | Tacrolimus Sustained-release Capsules | 1 | 1 | 6 |
| 9 | Tafluprost Eye Drops | 1 | 1 | 3 |
| 10 | Lidocaine Cataplasms | 1 | 1 | 7 |
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
166 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Mei Lin Pharma Co., Ltd. romanized | 22 | 16 | 0 |
| 2 | Shanghai Yan An Pharma Co., Ltd. romanized | 12 | 11 | 0 |
| 3 | Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 4 | Vetter Pharma-Fertigung GmbH & Co. KG | 8 | 2 | 0 |
| 5 | Da Lian Tian Shan Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Takeda Development Center Americas Inc. | 4 | 2 | 0 |
| 9 | Beijing Pu Run Ao Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | FUJIFILM Diosynth Biotechnologies UK Ltd | 3 | 3 | 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
85 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/09/26Generic · Class 3 | Allopurinol TabletsCYHS2201610 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2022/09/26Generic · Class 3 | Allopurinol TabletsCYHS2201609 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2022/09/26New drug · Class 1 | 重组人源化单克隆抗体MIL93注射液 · No verified English nameCXSL2200483 | Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized |
| 2022/09/26New drug · Class 1 | 重组人IL12/15-PDL1B单纯疱疹Ⅰ型溶瘤病毒注射液(Vero细胞) · No verified English nameCXSL2200482 | Zhong Sheng Fu Nuo Jian Bio Technology (Shanghai) Co., Ltd. romanized |
| 2022/09/25Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2201608 | Chengdu Giantech Hi-technology Development Co., Ltd.; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized |
| 2022/09/25Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2201607 | Chengdu Giantech Hi-technology Development Co., Ltd.; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized |
| 2022/09/24Import · Class 1 | ALXN1720注射液 · No verified English nameJXSL2200172 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/09/24Import · Class 1 | Futuximab/Modotuximab 注射液 (S95026) · No verified English nameJXSL2200171 | Institut de Recherches Internationales Servier; Servier (Beijing) Pharmaceutical Research & Development CO. LTD |
| 2022/09/24Import · Class 1 | Nemtabrutinib片 · No verified English nameJXHL2200294 | Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2022/09/24Import · Class 1 | Nemtabrutinib片 · No verified English nameJXHL2200293 | Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2022/09/24Generic · Class 3 | Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2201604 | Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized |
| 2022/09/24New drug · Class 2.3 | 养正消积胶囊 · No verified English nameCXZL2200043 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2022/09/24New drug · Class 1 | 靶向HLA-A*02:01/NY-ESO-1的TCR-T细胞注射液 · No verified English nameCXSL2200481 | Shenzhen Pu Rui Jin Bio Pharma Co., Ltd. romanized |
| 2022/09/24New drug · Class 1 | GC301腺相关病毒注射液 · No verified English nameCXSL2200480 | Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized |
| 2022/09/24New drug · Class 1 | 注射用QLS31903 · No verified English nameCXSL2200479 | Qilu Pharmaceutical Co., Ltd. |
| 2022/09/24New drug · Class 1 | 伯瑞替尼肠溶胶囊 · No verified English nameCXHS2200048 | Beijing Pu Run Ao Bio Technology Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2022/09/24New drug · Class 1 | 伯瑞替尼肠溶胶囊 · No verified English nameCXHS2200047 | Beijing Pu Run Ao Bio Technology Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2022/09/23Import · Class 1 | Mezagitamab 注射剂 · No verified English nameJXSL2200170 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd. |
| 2022/09/23Generic · Class 3 | Lidocaine Hydrochloride GelCYHS2201594 | Nanjing Han Xin Pharmaceuticals Technology Co., Ltd. romanized; Mei Yao Xing (Nanjing) Pharmaceutical Co., Ltd. romanized |
| 2022/09/23Generic · Class 3 | Sevelamer Carbonate Powder for oral suspensionCYHS2201593 | Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized |
| 2022/09/23Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2201592 | Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Jian Min Pharma Group Co., Ltd. romanized |
| 2022/09/23New drug · Class 1 | C-13-60细胞制剂 · No verified English nameCXSL2200478 | Chongqing Jing Zhun Bio Technology Co., Ltd. romanized |
| 2022/09/23New drug · Class 1 | ILB-2101注射液 · No verified English nameCXSL2200477 | Ying Nuo Hu Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2022/09/23New drug · Class 1 | YH001注射液 · No verified English nameCXSL2200476 | Name not romanized |
| 2022/09/23New drug · Class 1 | 1A46注射液 · No verified English nameCXSL2200475 | Chengdu En Mu Bio Technology Co., Ltd. romanized; Hai Zheng Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized |
| 2022/09/23New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2200734 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2022/09/23New drug · Class 1 | 伊匹乌肽滴眼液 · No verified English nameCXHL2200733 | Shenzhen Yi Xin Kang Bio Technology Co., Ltd. romanized |
| 2022/09/23New drug · Class 1 | GT919胶囊 · No verified English nameCXHL2200732 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2022/09/23New drug · Class 1 | GT919胶囊 · No verified English nameCXHL2200731 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2022/09/23New drug · Class 1 | GT919胶囊 · No verified English nameCXHL2200730 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
55 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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