YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 182 drug applications between 28 May 2021 and 3 June 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 27, covering 17 drug names.
2021/05/28 – 2021/06/03
- New acceptances this week
- 182
- Drugs with new generic filings (by drug name, de-duplicated)
- 17
- 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
182filings, 27 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 110 |
| Generic | 27 |
| New drug | 21 |
| Import | 19 |
| Unspecified | 4 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 127 |
| TCM | 27 |
| Therapeutic biologic | 22 |
| Prophylactic biologic | 6 |
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
17 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Latamoxef Sodium for Injection | 3 | 1 | 1 |
| 2 | Edoxaban Tosilate Tablets | 3 | 1 | 9 |
| 3 | Linezolid and Glucose Injection | 2 | 1 | 3 |
| 4 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 5 | 盐酸罗哌卡因氯化钠注射液 · No verified English name | 2 | 1 | 0 |
| 6 | Moxifloxacin Hydrochloride Eye Drops | 2 | 1 | 4 |
| 7 | 硫酸沙丁胺醇雾化吸入溶液 · No verified English name | 2 | 1 | 0 |
| 8 | Febuxostat Tablets | 2 | 1 | 12 |
| 9 | Lacosamide Injection | 1 | 1 | 0 |
| 10 | Azithromycin For Injection | 1 | 1 | 11 |
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
104 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Beijing Bao Nian Tang (He Ze) Pharma Co., Ltd. romanized | 16 | 15 | 0 |
| 2 | Guangzhou Bai Te Medical Yong Pin Co., Ltd. romanized | 6 | 3 | 0 |
| 3 | Shanghai Shang Yao Rui Er Medicines Co., Ltd. romanized | 5 | 4 | 0 |
| 4 | Guangzhou Run Er Yan Ke Bio Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 5 | Pfizer Europe MA EEIG | 4 | 3 | 0 |
| 6 | Celgene Corporation | 4 | 1 | 0 |
| 7 | Janssen Pharmaceuticals Inc. | 4 | 1 | 0 |
| 8 | Genzyme Europe B.V. | 3 | 2 | 0 |
| 9 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized | 3 | 2 | 0 |
| 10 | Bristol-Myers Squibb Company | 3 | 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 |
|---|---|---|
| 2021/06/03Import · Class 1 | HBM9161(HL161BKN)注射液 · No verified English nameJXSL2101037 | Harbour BioMed Therapeutics Limited; He Bo Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/06/03Import · Class 1 | Troriluzole 胶囊 · No verified English nameJXHL2101078 | Bioshin Limited; BioShin (Shanghai) Co. Ltd. |
| 2021/06/03Import · Class 1 | Troriluzole 胶囊 · No verified English nameJXHL2101077 | Bioshin Limited; BioShin (Shanghai) Co. Ltd. |
| 2021/06/03Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2101254 | Shandong Run Ze Pharmaceutical Co., Ltd. romanized |
| 2021/06/03Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2101253 | Shandong Run Ze Pharmaceutical Co., Ltd. romanized |
| 2021/06/03Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2101252 | Shandong Run Ze Pharmaceutical Co., Ltd. romanized |
| 2021/06/03Generic · Class 3 | Milrinone and Glucose InjectionCYHS2101246 | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized |
| 2021/06/03New drug · Class 1 | EMB-06 注射液 · No verified English nameCXSL2101108 | Shanghai An Mai Bio Technology Co., Ltd. romanized |
| 2021/06/03New drug · Class 1 | SYHX1903片 · No verified English nameCXHL2101171 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2021/06/03New drug · Class 1 | SYHX1903片 · No verified English nameCXHL2101170 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2021/06/03New drug · Class 1 | FH-2001胶囊 · No verified English nameCXHL2101169 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized |
| 2021/06/03New drug · Class 1 | FH-2001胶囊 · No verified English nameCXHL2101168 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized |
| 2021/06/02Import · Class 2.2 | 萨特利珠单抗注射液 · No verified English nameJXSL2101036 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2021/06/02Import · Class 1 | GSK3228836 注射液 · No verified English nameJXHL2101076 | GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. LTD |
| 2021/06/02Generic · Class 3 | 硫酸沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2101229 | Shanghai Bao Long Bio Technology Co., Ltd. romanized; Shanghai Zhao Hui Pharma Co., Ltd. romanized |
| 2021/06/02New drug · Class 3.2 | 人血管性血友病因子 · No verified English nameCXSL2101101 | Bo Ya Biopharmaceutical Group Co., Ltd. romanized |
| 2021/06/01Import · Class 1 | BMS-986165片 · No verified English nameJXHL2101075 | Bristol-Myers Squibb Company; Name not romanized |
| 2021/06/01Import · Class 1 | BMS-986165片 · No verified English nameJXHL2101074 | Bristol-Myers Squibb Company; Name not romanized |
| 2021/06/01Import · Class 1 | BMS-986165片 · No verified English nameJXHL2101073 | Bristol-Myers Squibb Company; Name not romanized |
| 2021/06/01Import · Class 2.4 | Encorafenib胶囊 · No verified English nameJXHL2101071 | Array BioPharma Inc a wholly owned subsidiary of Pfizer Inc; Pfizer Investment CO. Ltd. |
| 2021/06/01Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2101224 | Beijing Shi Xin Li Cheng Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2021/06/01New drug · Class 1 | Ociperlimab注射液 · No verified English nameCXSL2101105 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2021/06/01New drug · Class 1 | HB0030注射液 · No verified English nameCXSL2101104 | Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized; Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized |
| 2021/06/01New drug · Class 1 | 注射用CU-20401 · No verified English nameCXSL2101098 | Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized |
| 2021/05/31Import · Class 1 | CC-220胶囊 · No verified English nameJXHL2101070 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2021/05/31Import · Class 1 | CC-220胶囊 · No verified English nameJXHL2101069 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2021/05/31Import · Class 1 | CC-220胶囊 · No verified English nameJXHL2101068 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2021/05/31Import · Class 1 | CC-220胶囊 · No verified English nameJXHL2101067 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2021/05/31New drug · Class 1 | 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2101103 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2021/05/31New drug · Class 1 | 重组人源化抗表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2101102 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
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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