YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 252 drug applications between 21 August 2021 and 27 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 36, covering 26 drug names.
2021/08/21 – 2021/08/27
- New acceptances this week
- 252
- Drugs with new generic filings (by drug name, de-duplicated)
- 26
- Accepted this week, now under review
- 3
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
252filings, 36 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 169 |
| Generic | 36 |
| New drug | 29 |
| Import | 12 |
| Import re-registration | 4 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 140 |
| TCM | 68 |
| Therapeutic biologic | 36 |
| Prophylactic biologic | 6 |
| Biologic | 2 |
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
26 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation | 3 | 1 | 12 |
| 2 | Edoxaban Tosilate Tablets | 3 | 1 | 9 |
| 3 | 吸入用七氟烷 · No verified English name | 2 | 1 | 0 |
| 4 | Perindopril tert-Butylamine Tablets | 2 | 1 | 5 |
| 5 | Ticagrelor Tablets | 2 | 1 | 10 |
| 6 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
| 7 | Desvenlafaxine Extended-release Tablets | 2 | 1 | 0 |
| 8 | Polidocanol Injection | 2 | 1 | 23 |
| 9 | Rivaroxaban Tablets | 1 | 1 | 3 |
| 10 | Ipratropium Bromide Inhalation Solution | 1 | 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
122 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Ye Zhen Tang Pharma Co., Ltd. romanized | 22 | 22 | 0 |
| 2 | Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized | 16 | 15 | 0 |
| 3 | GUERBET | 13 | 1 | 0 |
| 4 | Guangxi Ge Hong Tang Fang Lve Pharmaceutical Co., Ltd. romanized | 7 | 7 | 0 |
| 5 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 5 | 2 | 5 |
| 6 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Yuan He Sheng (Jilin) Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Qin Huang Dao Da En Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Health Yuan Pharma Group Co., Ltd. romanized | 4 | 2 | 3 |
| 10 | AstraZeneca UK Limited | 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
44 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/08/27Import · Class 1 | Rozanolixizumab注射液 · No verified English nameJXSL2101103 | UCB Pharma SA; UCB Trading (Shanghai) Co. Ltd |
| 2021/08/27Import · Class 1 | HBM9161(HL161BKN)注射液 · No verified English nameJXSL2101102 | Harbour BioMed Therapeutics Limited; He Bo Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/08/27Generic · Class 3 | Desvenlafaxine Extended-release TabletsCYHS2101652 | Zhejiang Jian Feng Pharma Co., Ltd. romanized |
| 2021/08/27Generic · Class 3 | Desvenlafaxine Extended-release TabletsCYHS2101651 | Zhejiang Jian Feng Pharma Co., Ltd. romanized |
| 2021/08/27Generic · Class 3 | 法维拉韦片 · No verified English nameCYHS2101646 | Beijing Si Huan Pharmaceutical Co., Ltd. romanized |
| 2021/08/27New drug · Class 1.1 | 乳藤胶囊 · No verified English nameCXZL2101023 | Zhong Nan Min Zu University romanized |
| 2021/08/27New drug · Class 1 | UBP1213sc注射液 · No verified English nameCXSL2101290 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/08/27New drug · Class 3.3 | 阿柏西普眼内注射溶液 · No verified English nameCXSL2101289 | Sichuan San Ye Cao Biopharmaceutical Co., Ltd. romanized |
| 2021/08/27New drug · Class 1 | YH001注射液 · No verified English nameCXSL2101288 | Name not romanized |
| 2021/08/27New drug · Class 1 | LBL-007注射液 · No verified English nameCXSL2101286 | Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized |
| 2021/08/27New drug · Class 3.3 | 长效重组人胰高血糖素样肽-1注射液 · No verified English nameCXSL2101283 | Beijing SL Pharmaceutical Co., Ltd. |
| 2021/08/27New drug · Class 3.3 | 长效重组人胰高血糖素样肽-1注射液 · No verified English nameCXSL2101282 | Beijing SL Pharmaceutical Co., Ltd. |
| 2021/08/27New drug · Class 1 | 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2101280 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2021/08/27New drug · Class 1 | GH21胶囊 · No verified English nameCXHL2101438 | Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/08/27New drug · Class 1 | GH21胶囊 · No verified English nameCXHL2101437 | Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/08/27New drug · Class 1 | GH21胶囊 · No verified English nameCXHL2101436 | Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/08/26Import · Class 1 | M7824 (MSB0011359C) · No verified English nameJXSL2101104 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2021/08/26Import · Class 3.3 | 乌司奴单抗注射液 · No verified English nameJXSL2101100 | Alvotech Swiss AG; Alvotech & CCHT Biopharmaceutical Co. Ltd. |
| 2021/08/26Generic · Class 3 | Doxorubicin Hydrochloride Liposome InjectionCYHS2101637 | Zhejiang Zhi Da Pharma Co., Ltd. romanized |
| 2021/08/26New drug · Class 1 | 注射用SKB315 · No verified English nameCXSL2101287 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2021/08/25Import · Class 1 | Rilzabrutinib囊片 · No verified English nameJXHL2101169 | Principia Biopharma Inc.; Sanofi (China) Investment Co. Ltd. |
| 2021/08/25New drug · Class 2.4 | α-双炔失碳酯肠溶片 · No verified English nameCXHL2101430 | Zhejiang Jia Chi Pharmaceuticals Kai Fa Co., Ltd. romanized |
| 2021/08/24Import · Class 1 | DS-1062a · No verified English nameJXSL2101101 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
| 2021/08/24Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2101630 | Beijing Fei Sen You Si Ka Bi Pharmaceuticals Co., Ltd. romanized; Nanjing Jian You Sheng Hua Pharmaceutical Co., Ltd. romanized |
| 2021/08/24New drug · Class 1 | IM21嵌合抗原受体T细胞注射液（IM21 CAR-T细胞注射液） · No verified English nameCXSL2101281 | Beijing Yi Miao Shen Zhou Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/08/24New drug · Class 1 | 重组抗金黄色葡萄球菌毒素人源化单克隆抗体注射液 · No verified English nameCXSL2101277 | Xing Meng Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/08/24New drug · Class 2.2 | 复方葡萄糖酸钙颗粒 · No verified English nameCXHS2101035 | Xinjiang Te Feng Pharma Co., Ltd. romanized |
| 2021/08/24New drug · Class 2.4 | 妥布霉素雾化吸入溶液 · No verified English nameCXHL2101429 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2021/08/24New drug · Class 2.4 | Irinotecan Liposome injectionCXHL2101428 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2021/08/24New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2101412 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
14 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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